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BIOCARTIS KONDIGT 2016 RESULTATEN, 2017 VOORUITZICHTEN EN VERANDERING IN CEO-POSITIE AAN Mechelen, België, 2 maart 2017 - Biocartis Group NV (de 'Vennootschap of 'Biocartis'), een innovatief bedrijf in de moleculaire diagnostiek (Euronext Brussels: BCART), kondigt vandaag zijn operationale hoogtepunten en financiële resultaten van 2016 aan, opgesteld in overeenstemming met IFRS zoals aanvaard binnen de EU. Verder kondigt Biocartis vandaag ook zijn 2017 vooruitzichten aan en een verandering in de CEO-positie van de Vennootschap. Verandering in CEO-positie Rudi Pauwels heeft zijn voorkeur geuit om te focussen op de langere termijn strategie van de Vennootschap,  inclusief een nieuw pad naar een Next-Generation Sequencing gebaseerd productaanbod. De Raad van Bestuur heeft daarom besloten dat Rudi Pauwels de rol van Voorzitter van een nieuw Strategisch Comité  van de Raad van Bestuur zal opnemen, en dat hij de rol van CEO aan een opvolger zal doorgeven. De Vennootschap vertrouwt erop dat een opvolger zal kunnen worden aangekondigd in de eerstvolgende maanden. Hilde Windels, huidige Deputy CEO, zal de rol van CEO opnemen tot een opvolger aangeduidt is. Biocartis organiseert vandaag een webcastpresentatie om 14:00 CET / 13:00 BST (UK) / 08:00 EDT (US) om de 2016 resultaten te bespreken. Klik hier voor toegang tot de live webcast. Wie aan de vraag- en antwoordsessie wil deelnemen, gelieve 5-10 minuten vóór de starttijd in te bellen op +44(0)20 3427 1901 (standaard internationaal), gevolgd door de bevestigingscode 9539312. De webcast en telefoonconferentie zullen in het Engels gevoerd worden. Een herhaling van de webcast zal kort nadien ter beschikking zijn op de Biocartis website. Rudi Pauwels, Chief Executive Officer van Biocartis, bekommentarieerde de 2016 resultaten als volgt: "Onze performantie in 2016 en de voortdurende feedback die we van onze klanten en hun patiënten  ontvangen, bevestigt ons geloof dat we met Idylla(TM) de wereldwijde markt van moleculaire diagnose kunnen impacteren. We blijven een verhoogde interesse zien van grote farmaceutische bedrijven voor makkelijke en snelle moleculaire diagnose testing, nodig voor hun hoge precisie behandelingen en ook om het gezondheidsmodel duurzaam te maken. We zagen dit al vertaald in nieuwe, waardevolle lange termijn partnerschappen voor Biocartis. Voortdurende innovatie in kankerbehandelingen, zoals monitoring gebaseerd op vloeibare biopsieën, geeft ook aan dat de markt voor onze huidige en toekomstige producten groter is dan aanvankelijk gedacht. Er is echter nog werk voor de boeg om onze ambities waar te maken. De start van de commercialisatie in de VS in 2017 is hierin een belangrijke volgende stap; niet alleen omwille van de grootte van deze markt, maar ook door de huidige gecentraliseerde moleculaire diagnose testmarkt in de VS, wat onze klanten zal toelaten om optimaal voordeel te halen uit de USP's die Idylla(TM) te bieden heeft. 2017 wordt zeker en vast nog een interessant jaar voor Biocartis!" Verandering CEO-positie Na de positie voor meer dan 10 jaar vervuld te hebben, heeft Stichter Rudi Pauwels zijn voorkeur geuit aan de Raad van Bestuur om te focussen op de langere termijn strategie van de Vennootschap, inclusief een pad naar een Next-Generation Sequencing gebaseerd productaanbod. De Raad van Bestuur heeft daarom besloten dat Rudi Pauwels de rol van Voorzitter van een nieuw Strategisch Comité binnen de Raad van Bestuur zal opnemen, en dat Hilde Windels de rol van CEO zal opnemen tot een opvolger voor Rudi Pauwels is aangesteld. Sinds de benoeming van Hilde Windels als Deputy CEO in 2015 was Rudi Pauwels al meer gefocust op de strategie en visie van Biocartis, terwijl het dagelijks management gedelegeerd werd naar Hilde Windels. De Vennootschap vertrouwt erop dat een opvolger zal kunnen worden aangekondigd in de eerstvolgende maanden. Rudi Pauwels, Stichter van Biocartis, reageerde als volgt: "Tien jaar geleden hebben we een reis  aangevat  om hoge precisie moleculaire diagnose oplossingen te ontwikkelen die, door hun design, toegankelijker zouden zijn voor laboratoria en gezondheidszorginstellingen in de hele wereld. Ik had het plezier om intens samen te werken met een fantastisch team op de ontwikkeling van het Idylla(TM) platform, dat zijn ontstaan kende bij Philips. De CE-markering eind 2014 was het begin van de commerciële fase en, ondersteund door een groeiend aantal testen, vindt de Idylla(TM) oplossing nu steeds meer zijn weg naar klanten in Europa en in de hele wereld. Ik ben in het bijzonder tevreden om te zien dat het harde werk tijdens de ontwikkeling zich vertaald heeft in fantastische performantie van onze eerste testen. Voortbouwend op deze fundamenten, is het nu belangrijk voor Biocartis om zich steeds meer te richten op wereldwijde commerciële expansie en op de weg naar het uitbouwen van aanzienlijke toplijn inkomsten. Daarom meen ik dat de tijd rijp is om de fakkel als CEO door te geven en ik ben tevreden dat Hilde Windels, die de voorbije 6 jaar aan mijn zijde heeft gewerkt, de rol als interim CEO aanneemt. Zo zal ik, vanuit een andere hoedanigheid, mijn focus op innovatie en strategie nog meer kunnen versterken. Ik kijk ernaar uit om bij Biocartis betrokken te blijven en het bedrijf te begeleiden in de uitrol van innovatieve producten en doorbraken die volgens mij een aanzienlijke bijdrage zullen kunnen maken aan de groeiende rol van moleculaire diagnose in de gezondheidszorg." Rudi Mariën, Voorzitter van Biocartis, voegde hieraan toe: "We zijn dankbaar voor Rudi's toewijding aan Biocartis de voorbije jaren. Zonder hem zou Biocartis niet zijn wat het vandaag is. Onder zijn leiderschap lanceerde het bedrijf zijn vooraanstaand Idylla(TM) programma, haalde het EUR 115 miljoen op in zijn beursgang en zette het beloftevolle samenwerkingen op met leidende bedrijven in de gezondheidszorg, waaronder Johnson and Johnson, Abbott, Amgen, Merck en Thermo Fisher Scientific. We zijn tevreden dat Rudi actief zal blijven in de raad van bestuur, waardoor Biocartis zal kunnen blijven putten uit zijn visionaire inzichten over hoe we onze beloftes kunnen blijven verwezenlijken als één van de koplopers op vlak van innovatie." Kerncijfers 2016 De tabellen hieronder tonen een overzicht van de kerncijfers en een opsplitsing van de bedrijfsinkomsten voor 2016. De geconsolideerde winst- en verliesrekening, de balans, het kasstroomoverzicht en het geconsolideerd mutatieoverzicht van het eigen vermogen van Biocartis Group NV vind je onder 'Financiële informatie' op het einde van dit persbericht. Een overzicht van de tabellen met de kerncijfers 2016 is terug te vinden in de volledige tekst van het persbericht in bijlage. In 2016 bedroegen inkomsten uit samenwerkingen, voornamelijk bestaande uit erkende vooruitbetalingen van licenties en mijlpaalbetalingen van strategische partners,  EUR 5,3 miljoen in vergelijking met EUR 9,7 miljoen in 2015, een daling van ongeveer 46%. Dit was voornamelijk te wijten aan het feit dat in EUR 4,0 miljoen eenmalige mijlpaalbetalingen werden ontvangen, versus EUR 332k mijlpaalbetalingen ontvangen in 2016 (een daling van ongeveer 92%). Erkende inkomsten uit vooruitbetalingen van licenties enerzijds bedroegen EUR 4,7 miljoen, wat een daling van ongeveer 7% vertegenwoordigt. Inkomsten uit productverkopen anderzijds stegen met ongeveer 88% in 2016 tot EUR 6,8 miljoen van EUR 3,6 miljoen in 2015, voornamelijk door de hogere commerciële cartridge verkopen. Erkende subsidies en andere inkomsten in 2016 bedroegen EUR 1,7 miljoen, een stijging van 3,5% in vergelijking met 2015. In 2016 ontving Biocartis twee nieuwe subsidies voor een totaal bedrag van EUR 3,9 miljoen, bestaande uit een EUR 2,5 miljoen strategische steun subsidie van het Vlaams Agentschap voor Innoveren en Ondernemen onder zijn Strategische Transformatiesteun ('STS') programma om de uitbreiding van de productiecapaciteit te ondersteunen (18 oktober 2016) en een EUR 1,4 miljoen subsidie van VLAIO, de Vlaamse organisatie voor Innoveren en Ondernemen, ter ondersteuning van de ontwikkeling van snelle NGS Prep Panel testen (31 oktober 2016). Van deze subsidies werd EUR 0,4 miljoen erkend in 2016. De totale bedrijfsinkomsten in 2016 bedroegen aldus EUR 13,8 miljoen in vergelijking met EUR 15,0 miljoen in 2015. De totale bedrijfskosten in 2016 bedroegen EUR 63,9 miljoen in vergelijking met EUR 54,6 miljoen in 2015, een stijging van 17%. Dit omvatte EUR 5,7 miljoen verkoopskosten in vergelijking met EUR 2,6 miljoen in 2015, gedreven door de stijging van inkomsten uit productverkopen in 2016. Naast de verkoopskosten, stegen de bedrijfskosten in 2016 van EUR 52,0 miljoen in 2015 naar EUR 58,2 miljoen, een stijging van 12,1% te wijten aan hogere kosten in onderzoek & ontwikkeling (O&O) en marketing & distributie en lagere algemene & administratieve kosten. Uitgaven voor onderzoek & ontwikkeling stegen van EUR 36,6 miljoen in 2015 met 15,1% in 2016 naar EUR 42,1 miljoen. Dit was het gevolg van gestegen personeels- (en gerelateerde) kosten en gestegen onderzoek & ontwikkelingsactiviteiten voor test- en platformontwikkeling die gedeeltelijk gecompenseerd werden door lagere uitgaven voor subcontracting. De stijging in personeels- en gerelateerde kosten werd gedreven door de stijging van 38 personeelsleden in het O&O team in 2015 (de meerderheid werd pas gerekruteerd tegen het einde van 2015, waardoor de personeelskosten voor deze medewerkers bijgevolg pas in 2016 een volledige jaarimpact hadden) alsmede een stijging in het O&O personeelsbestand met 5 medewerkers in 2016. In 2016 breidde het marketing & distributieteam uit met 16 medewerkers, waarvan velen onder hen al als externe medewerker vanuit Janssen Pharmaceutica NV actief waren sinds 2015. Dat was ook de voornaamste reden van daling van de subcontracting kosten in 2016. Algemene & administratieve kosten daalden in 2016 met 12,5% naar EUR 5,8 miljoen (EUR 6,7 miljoen in 2015) door de lagere uitgaven voor extern advies (2015 was uitzonderlijk geïmpacteerd door de beursgang van Biocartis in april 2015), voor facilities & office en voor personeel, hetgeen gedeeltelijk gecompenseerd werd door gestegen personeelskosten. Het bedrijfsresultaat in 2016 bedroeg een verlies van EUR 50,2 miljoen in vergelijking met een verlies van EUR 39,7 miljoen in 2015. Als resultaat van het voorgaande steeg het verlies voor het jaar na belastingen van EUR 39,8 miljoen in 2015 naar EUR 49,7 miljoen in 2016. Vaste activa bestonden voornamelijk uit, onder andere, productiemateriaal (inclusief materiaal eigendom van Biocartis, materiaal onder leasing en materiaal dat onder constructie is voor de uitbreiding van zijn huidige cartridge productielijn en voor de bouw van zijn tweede cartridge productielijn), Idylla(TM) systemen geplaatst bij klanten (onder operationele leasecontracten of huurcontracten) of voor intern gebruik, alsook laboratorium & ICT materiaal. In 2016 stegen de vaste activa met EUR 8,8 miljoen van EUR 14,2 miljoen in 2015 naar EUR 23,1 miljoen als resultaat van de investeringen (netto, na desinvesteringen) van EUR 12,6 miljoen en afschrijvingen van EUR 3,8 miljoen. Investeringen bestonden voornamelijk uit productiemateriaal en Idylla(TM) systemen voor intern gebruik en systemen geplaatst bij klanten onder operationele leasecontracten of huurcontracten. Handelsvorderingen daalden in 2016 met EUR 2,9 miljoen van EUR 5,9 miljoen in 2015 naar EUR 2,9 miljoen, voornamelijk door de ontvangen mijlpaal- en vooruitbetalingen van strategische partners. Andere vorderingen waren gerelateerd aan BTW-vorderingen en kapitaalsubsidies en bedroegen EUR 2,2 miljoen op het einde van 2016. Andere vlottende activa omvatten verworven subsidie-inkomsten en uitgestelde kosten en stegen in 2016 naar EUR 1,9 miljoen in vergelijking met EUR 1,3 miljoen in 2015. De totale financiële schuld bedroeg EUR 31,4 miljoen op het einde van 2016, wat een stijging van EUR 20,6 miljoen vertegenwoordigt in vergelijking met de EUR 10,8 miljoen totale financiële schuld die openstond eind 2015. De stijging is voor EUR 12,6 miljoen gerelateerd aan de verkregen lease financiering voor het bekostigen van de investeringen voor Biocartis' huidige en tweede cartridge productielijn. Bovendien is de EUR 8,1 miljoen gerelateerd aan de nieuwe achtergestelde lening van EUR 15,0 miljoen die de Vennootschap verkreeg in juli 2016 om een bestaande achtergestelde lening te herfinancieren (nominaal bedrag van EUR 5m, exclusief opgelopen rentekosten) die afliep eind 2016. Het korte termijngedeelte van de lange termijn schuld op 31 december 2016 bedroeg EUR 3,7 miljoen en het langetermijn gedeelte bedroeg EUR 27,7 miljoen. De handelsschulden eind 2016 bedroegen EUR 6,3 miljoen, hetgeen een daling vertegenwoordigde van EUR -7,6 miljoen in vergelijking met de EUR 13,9 miljoen openstaand eind 2015. Deze daling was voornamelijk te wijten aan facturen ontvangen in 2015 voor de uitbreiding van de productie, die in 2016 betaald werden. Uitgesteld inkomen daalde in 2016 naar EUR 2,1 miljoen (EUR 5,2 miljoen eind 2015), voornamelijk door de erkenning van vooruitbetaalde vergoedingen van Janssen Pharmaceutica m.b.t. de strategische licentie-, ontwikkelings- en commersialisatie samenwerkingen. Kasstroom De kasstroom uit bedrijfsactiviteiten bedroeg EUR -53,4 miljoen in 2016 in vergelijking met EUR -27,3 miljoen  in 2015, dit door een stijgend verlies voor de periode (voornamelijk te wijten aan hogere bedrijfsuitgaven) in combinatie met investeringen in werkkapitaal in 2016 in vergelijking met aanzienlijke positieve bewegingen in werkkapitaal voor 2015. De kasstroom uit investeringsactiviteiten in 2016 bedroeg EUR -9,3 miljoen in vergelijking met EUR -5,4 miljoen in 2015, voornamelijk gedreven door de gestegen investeringen voor de uitbreiding van de cartridge productie en hogere investeringen in immateriële activa, voornamelijk bestaande uit software en IP licenties. De kasstroom uit financieringsactiviteiten bedroeg in 2016 EUR 41,8 miljoen, gedreven door de netto opbrengsten van de private plaatsing in november 2016 en opbrengsten uit nieuwe leningen, alsook de opbrengsten ontvangen van de leasing financieringsverstrekker van de Vennootschap gerelateerd aan het productiemateriaal dat initieel door Biocartis was betaald en nadien herfinancierd werd met lease financiering. De  kasstroom uit financieringsactiviteiten in 2015 bedroeg EUR 125,9 miljoen, hetgeen uitzonderlijk was ten gevolge van de netto opbrengsten uit de beursgang van de Vennootschap in april 2015. Gedreven door het bovenstaande bedroeg de totale netto kasstroom in 2016 EUR -20,9 miljoen in vergelijking met EUR 93,2 miljoen in 2015. Webcast en presentatie Biocartis organiseert een conference call met live webcast om de 2016 resultaten voor te stellen, gevolgd door een vraag- en antwoordsessie. Deze gaat vandaag door, op 2 maart 2017, om 14:00 CET / 13:00 BST (VK) / 08:00 EDT (VS). Klik hier voor toegang tot de webcast. Wie wil deelnemen in de vraag- en antwoordsessie,  gelieve in te bellen op +44(0)20 3427 1901 (standaard internationaal) met bevestigingscode 9539312. Een herhaling van de webcast zal kort nadien ter beschikking zijn op de Biocartis website (onder 'investeerders'). Financiële informatie De geconsolideerde jaarrekening werd opgesteld in overeenstemming met IFRS, zoals aanvaard binnen de EU. De financiële informatie opgenomen in dit persbericht is een uittreksel uit de volledige IFRS geconsolideerde financiële jaarrekening, die gepubliceerd zal worden op 30 maart 2017. De commissaris, Deloitte Bedrijfsrevisoren/Reviseurs d'Entreprises, vertegenwoordigd door Gert Vanhees, heeft de controlewerkzaamheden voor de IFRS geconsolideerde jaarrekening over het boekjaar afgesloten op 31 december 2016, ten gronde voltooid en heeft bevestigd dat de geconsolideerde balans, het geconsolideerde overzicht van het totaalresultaat, het geconsolideerde kasstroomoverzicht en en het geconsolideerde mutatieoverzicht van het eigen vermogen, opgenomen in dit persbericht, zonder materiële afwijkingen overeenstemmen met de geconsolideerde jaarrekening op basis waarvan deze werden opgemaakt. Een overzicht van de geconsolideerde resultatenrekening, de geconsolideerde balans, het geconsolideerd kasstroomoverzicht en het geconsolideerd mutatieoverzicht van het eigen vermogen is terug te vinden in de volledige tekst van het persbericht in bijlage. Over Biocartis  Biocartis (Euronext Brussels: BCART) is een innovatief bedrijf in de moleculaire diagnostiek (MDx) dat diagnostische oplossingen van de nieuwste generatie aanbiedt om de klinische praktijk te verbeteren ten voordele van de patiënt, clinici, kostendragers en de sector. Het Idylla(TM) MDx systeem van Biocartis is een volledig geautomatiseerd, staal-tot-resultaat real-time PCR-systeem (Polymerase Chain Reaction ofwel Polymerasekettingreactie) dat accurate, zeer betrouwbare moleculaire informatie verstrekt op basis van nagenoeg elk biologisch staal, in nagenoeg elke omgeving. Biocartis lanceerde in 2014 het Idylla(TM) platform. Biocartis ontwikkelt en commercialiseert een snel uitbreidend testmenu dat voldoet aan belangrijke onvoldane klinische behoeften in oncologie en infectieziekten. Deze domeinen zijn respectievelijk het snelst groeiende en het grootste segment van de MDx-markt wereldwijd. Vandaag heeft Biocartis acht oncologietesten en twee infectieziektentesten op de markt. Meer informatie op www.biocartis.com. Persfoto's vindt  u hier. Volg ons op Twitter: @Biocartis_. Bepaalde uitdrukkingen, overtuigingen en opinies in dit persbericht zijn naar de toekomst gericht, en geven de huidige intenties, overtuigingen, verwachtingen en projecties weer van de Vennootschap en van haar bestuurders en management, betreffende toekomstige gebeurtenissen zoals de resultaten van de Vennootschap, haar financiële toestand, liquiditeit, prestaties, vooruitzichten, groei, strategieën en de industrie waarin de Vennootschap actief is. Het is eigen aan toekomstgerichte verklaringen dat zij een aantal risico's, onzekerheden, veronderstellingen, en andere factoren inhouden die werkelijke resultaten of gebeurtenissen materieel kunnen doen verschillen van deze uitgedrukt of verondersteld door de toekomstgerichte verklaringen. Deze risico's, onzekerheden, veronderstellingen en factoren kunnen een negatief effect hebben op de uitkomst en financiële gevolgen van de plannen en gebeurtenissen hierin beschreven. Een verscheidenheid aan factoren inclusief, maar niet beperkt tot, veranderingen in vraag, concurrentie en technologie, kunnen werkelijke gebeurtenissen, prestaties of resultaten wezenlijk doen verschillen van de verwachte ontwikkeling. Toekomstgerichte verklaringen in dit persbericht betreffende tendensen of activiteiten in het verleden staan niet garant voor toekomstige resultaten en dienen niet te worden beschouwd als een garantie dat zulke tendensen en activiteiten voortduren in de toekomst. Tevens, zelfs indien werkelijke resultaten of ontwikkelingen consistent zijn met de toekomstgerichte verklaringen in dit persbericht, geven deze resultaten of ontwikkelingen geen indicatie omtrent resultaten of ontwikkelingen in de toekomst. Bijgevolg neemt de Vennootschap uitdrukkelijk afstand van elke verplichting of verbintenis om enige update of wijziging te publiceren van enige toekomstgerichte verklaring in dit persbericht resulterend uit veranderingen in verwachtingen of in gebeurtenissen, voorwaarden, veronderstellingen of omstandigheden waarop deze toekomstgerichte verklaringen zijn gebaseerd. Noch de Vennootschap, noch haar adviseurs of vertegenwoordigers, noch haar dochtervennootschappen of haar kaderleden of werknemers garanderen dat de veronderstellingen waarop zulke toekomstgerichte verklaringen gebaseerd zijn, vrij zijn van fouten, noch aanvaarden zij enige verantwoordelijkheid voor de toekomstige nauwkeurigheid van de toekomstgerichte verklaringen opgenomen in dit persbericht of het werkelijk plaatsvinden van de voorspelde ontwikkelingen. U mag geen onvoorwaardelijk vertrouwen plaatsen in toekomstgerichte verklaringen aangezien zij enkel van toepassing zijn op de datum van dit persbericht. [5] Het gaat over een nieuwe reeks mutaties in het EGFR-ectodomein. Terwijl de meer gekende EGFR-mutaties zich in het kinasedomein van de EGFR-receptor bevinden, hetgeen zich binnenin de cel bevindt, is het EGFR-ectodomein het deel van de receptor die zich buiten de cel bevindt. Dit is waar de echte receptor-functie gelokaliseerd is waar EGF zich verbindt, en waar anti-EGFR antilichamen voor de behandeling van colorectale (darm)kanker zoals cetuximab en panitumumab de EGFR-receptor verbinden en zo EGF-binding voorkomen. [6] De analyse is op basis van een stukje FFPE (in formaline gefixeerde, in parrafine ingebedde) tumorweefsel. [7] Janku et al. BRAF Mutation Testing in Cell-Free DNA from the Plasma of Patients with Advanced Cancers Using a Rapid, Automated Molecular Diagnostics System. Mol Cancer Ther (2016) 15(6): 1-8; Schreuer et al. Quantitative assessment of BRAF V600 mutant cell-free tumor DNA from plasma as a diagnostic and therapeutic biomarker in patients with BRAF V600 mutant melanoma. ASCO 2015; De Biase et al. 'Fully Automated PCR detection of KRAS Mutations on Pancreatic Endoscopic Ultrasound Fine Needle Aspirates'. J Clin Pathol 2016; Reijans et al. ESMO 2016, gepubliceerd op 6 oktober 2016; De Luca et al., J Clin Pathol 2016; J.L. Sherwood et al., KRAS - ESMO Abstract 91 P: "Implications of key differences across 12 KRAS mutation detection technologies and their relevance in clinical practice", publically available on https://cslide.ctimeetingtech.com/library/esmo/browse/itinerary/5286/2016-10-10#2z95w; Ellen Vercauteren et al., NRAS - ESMO Abstract 1175P: "Ultra-rapid, sensitive, and fully automated extended RAS testing for metastatic colorectal cancer - evaluation of an NRAS/BRAF/EGFR492 module", publiek ter beschikking op https://cslide.ctimeetingtech.com/library/esmo/browse/itinerary/5286/2016-10-10#2z95w Preliminary Performance Study based on Research data. Martin Reijans et al., EGFR - ESMO Abstract 1173P: "Fully automated and sensitive detection of EGFR exon 18, 19, 20 and 21 mutational status in less than 2.5 hours from a single FFPE slice", publiek ter beschikking op https://cslide.ctimeetingtech.com/library/esmo/browse/itinerary/5286/2016-10-10#2z95w Jérôme Solassol et al., "Multi-Center Evaluation of the Fully Automated PCR-Based Idylla(TM) KRAS Mutation Assay for Rapid KRAS Mutation Status Determination on Formalin-Fixed Paraffin-Embedded Tissue of Human Colorectal Cancer", te downloaden op: http://journals.plos.org/plosone/article/asset?id=10.1371/journal.pone.0163444.PDF [8] James L. Sherwood, "Implications of Key Differences Across 12 KRAS Mutation Detection Technologies and Their Relevance in Clinical Practice", voor het eerst gepresenteerd tijdens ESMO in oktober 2016. [13] Onderbrekingen in DNA-herstelpaden zorgen ervoor dat cellen voorbestemd zijn om DNA-schade te accumuleren. Er is steeds meer bewijs voorhanden dat aantoont dat tumoren progressief meer mutaties in DNA-herstelproteïnes opstapelen, wanneer de kanker voortschrijdt. DNA-herstelmechanismen tasten in grote mate de responsgraad van cytotoxische behandelingen aan. Aldus is het begrijpen van deze mechanismen en het vinden van manieren om ontregelde herstelprocessen tegen zichzelf te keren om tumorsterfte te veroorzaken het doel van de inspanningen van DNA herstel-inhibitie. Bron: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4125008/, laatste geconsulteerd op 14 februari 2017.


Mechelen, Belgium, 2 March 2017 - Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces its operational highlights and financial results for 2016, prepared in accordance with IFRS as adopted by the European Union. Furthermore, the Company today provides its outlook for 2017 and announces a change in the Company's CEO position. Change in CEO position Rudi Pauwels has expressed his preference to focus on the longer term strategy of the Company, including a pathway towards a Next-Generation Sequencing based product offering. Therefore, the Board has decided that Rudi Pauwels will take on the role of Chairman of a new Strategy Committee of the Board and that he will pass on the role of CEO to a successor. The Company is confident that a successor can be announced in the next few months. Hilde Windels, currently Deputy CEO, will assume the role of CEO until a successor is on board. Biocartis will host a conference call with live webcast presentation today at 14:00 CET / 13:00 BST (UK) / 08:00 EDT (US) to discuss the 2016 results. Click here to access the live webcast.   To participate in the questions and answers session, please dial 5-10 minutes prior to the start time the number +44(0)20 3427 1901 (standard international), followed by the confirmation code 9539312.   The conference call and webcast will be conducted in English. A replay of the webcast will be available on the Biocartis investors' website shortly after. Commenting on the 2016 results, Rudi Pauwels, Chief Executive Officer of Biocartis, said: "Our 2016 performance and the continued feedback from our customers and their patients confirms our belief that with Idylla(TM) we can disrupt the global market of molecular diagnostics. We continue to see an increased interest by large pharmaceutical companies for easy and rapid molecular diagnostics testing needed for their high precision treatments, and to keep the healthcare model sustainable. We already saw this translated into valuable new long-term partnerships for Biocartis. Continued innovation around cancer treatments, such as liquid biopsy based monitoring, also indicates that the market for our current and future products is larger than initially thought. Still a lot of work is needed to materialize our ambitions. Starting commercialization in the US in 2017 is an important next step here. This not only because of the size of this market, but also due to the US' current centralized nature of MDx testing which will allow our clients to optimally benefit from the USPs Idylla(TM) has to offer. 2017 is definitely going to be another exciting year for Biocartis!" Update test menu strategy Biocartis continuously monitors market, technological and scientific developments that have an impact on the competitive positioning of its current and future menu of Idylla(TM) tests. These reviews have resulted in a menu optimization as summarized below: Additional background on the summarized menu update will be provided during today's webcast presentation at 14:00 CET. Change in CEO position After having fulfilled the CEO position for 10 years, Founder Rudi Pauwels has expressed his preference to the Board to focus on the longer term strategy of the Company, including a pathway towards a Next-Generation Sequencing based product offering. The board has decided that Rudi will take on the role of Chairman of a new Strategy Committee of the Board and that Hilde Windels will assume the role of CEO until a successor for Rudi Pauwels is on board. Since the appointment of Hilde Windels as Deputy CEO in 2015, Rudi Pauwels was already more focused on the strategy and vision of Biocartis, whereas the day to day execution was delegated to Hilde Windels. The Company is confident that a successor can be announced in the next few months. Rudi Pauwels, Founder of Biocartis, commented: "Ten years ago, we embarked on a journey to develop high precision molecular diagnostic solutions that by design would be more accessible to laboratories and healthcare settings around the globe. I had the pleasure to work intensely together with a great team on the development of the Idylla(TM) platform that has its roots at Philips. The CE-marking late 2014 was the beginning of the commercial phase and, fueled by a growing number of tests, the Idylla(TM) solution is now increasingly finding its way to customers in Europe and around the world. I am particularly pleased to see that the hard work during the development has translated into great performance of our first tests. Building further on these foundations, Biocartis must now increasingly focus on worldwide commercial expansion and on the pathway towards building significant top line revenue. I therefore feel it is time for me to hand over the torch as CEO and I am happy that Hilde Windels, with whom I have been working side-by-side over the last 6 years, is taking over from me as interim CEO. This will allow me to increase my focus on innovation and strategy even more, in another capacity. I look forward to continue to be involved with Biocartis and to assist the Company in its roll-out of innovative products and breakthrough solutions that I believe can make a significant contribution to the growing role of molecular diagnostics in healthcare." Rudi Mariën, Chairman of Biocartis, added: "We are thankful for Rudi's dedication to Biocartis over the past years. Without him, Biocartis would not have been what it is today. Under his leadership, the Company launched its flagship program Idylla(TM), successfully raised EUR 115m in its IPO and established promising partnerships with healthcare leaders including amongst others Johnson and Johnson, Abbott, Amgen, Merck and Thermo Fisher Scientific. We are pleased to see that Rudi will remain active on the Board, which will enable Biocartis to continue to benefit from his visionary views and insights on how to continue to deliver on our promises while remaining at the forefront of innovation." Key figures for 2016 The tables below show an overview of the key figures and a breakdown of operating income for 2016. A consolidated income statement, balance sheet, cash flow statement and statement of changes in equity of Biocartis Group NV is presented in the paragraph 'Financial information' at the end of this press release. Please find an overview of the key figures tables in the full version of the press release in attachment. Income statement In 2016, collaboration revenues, predominantly consisting of recognized upfront license revenues and milestone revenues from strategic partners, amounted to EUR 5.3m compared to EUR 9.7m in 2015, a decrease of approx. 46%. This was mainly driven by the fact that EUR 4.0m of one-off milestone payments were collected in 2015 versus EUR 332k of milestone payments that were received in 2016 (a decrease of approx. 92%). Recognized upfront license revenues amounted to EUR 4.7m, representing a decrease of approx. 7%. Product sales revenues on the other hand increased with approx. 88% in 2016 to EUR 6.8m from EUR 3.6m in 2015, predominantly driven by higher cartridge sales for commercial purposes. Recognized grants and other income in 2016 amounted to EUR 1.7m being a 3.5% increase compared to 2015. During 2016, Biocartis obtained two new grants for a total amount of EUR 3.9m, consisting of a EUR 2.5m strategic grant from the Flemish Agency for Innovation & Entrepreneurship under its Strategic Transformation Support ('STS') program to support manufacturing expansion capacity (18 October 2016) and a EUR 1.4m grant from VLAIO, the Flanders organization for Innovation & Entrepreneurship, to support development of its rapid NGS Prep Panels (31 October 2016). Of these grants, EUR 0.4m was recognized in 2016. Total operating income in 2016 consequently amounted to EUR 13.8m compared to EUR 15.0m in 2015. Total operating expenses in 2016 amounted to EUR 63.9m compared to EUR 54.6m in 2015, an increase of 17%. This included EUR 5.7m of cost of sales compared to EUR 2.6m in 2015, driven by the increase in product sales revenues in 2016. Excluding cost of sales, operating expenses increased in 2016 from EUR 52.0m in 2015 to EUR 58.2m, an increase of 12.1% driven by higher expenses in R&D and Marketing & Distribution and lower expenses for General & Administrative (G&A). R&D expenses increased from EUR 36.6m in 2015 with 15.1% in 2016 to EUR 42.1m. This as the consequence of increased staffing (and related costs) as well as increased R&D activities for test and platform development which were partially offset by lower expenses for subcontracting. The increase in staffing and related costs was driven by the 38 headcount increase of the R&D team in 2015 (majority was only recruited towards the end of 2015, staffing costs for these employees consequently only had a full year impact as of 2016) as well as a headcount increase of the R&D team with 5 employees in 2016. Marketing and Distribution expenses increased from EUR 8.7m in 2015 to EUR 10.3m in 2016 (18.0% increase) as a result of an expansion of the Marketing & Distribution team and increased sales and promotional expenses. During 2016, the Marketing & Distribution team was expanded with 16 employees of which several were already externally sourced from Janssen Pharmaceutica NV since 2015. That has also been the main reason for the decreased subcontracting costs in 2016. G&A expenses decreased in 2016 with 12.5% to EUR 5.8m (EUR 6.7m in 2015) due to lower expenses for external advice (2015 was exceptionally impacted by the Company's IPO in April 2015), facilities & office and human resources that were partially offset by increased staff costs. The operational result in 2016 amounted to a loss of EUR 50.2m compared to a loss of EUR 39.7m in 2015. As a result of the foregoing, the loss for the year after taxes increased from EUR 39.8m in 2015 to EUR 49.7m in 2016. Balance sheet Property plant & equipment predominantly consist, amongst others, of manufacturing equipment (including equipment owned by Biocartis, equipment held under lease and equipment that is under construction for the expansion of its current cartridge manufacturing line and for the building of its second cartridge manufacturing line), Idylla(TM) systems placed at clients (under operational lease contracts or rental contracts) or held for internal use as well as laboratory & ICT equipment. In 2016, property, plant & equipment increased with EUR 8.8m from EUR 14.2m in 2015 to EUR 23.1m as the results of investments (net, after disposals) of EUR 12.6m and depreciation of EUR 3.8m. Investments predominantly consisted of manufacturing equipment and Idylla(TM) systems for internal use and systems placed at clients under operational lease contracts or rental contracts. Deferred tax assets per 31 December 2016 amounted to EUR 3.1m and relate to tax credits for research and development in Belgium. Inventory increased from EUR 5.8m in 2015 to EUR 9.8m end of 2016 mainly driven by higher levels of raw materials and semi-finished products in view of the increased commercial cartridge volumes. Finished products included cartridges and systems held for expected commercialization, including systems placed at customers under the Company's early adopter program. Trade receivables decreased in 2016 with EUR 2.9m from EUR 5.9m in 2015 to EUR 2.9m mainly driven by collection of milestone and upfront payments from strategic partners. Other receivables related to VAT receivables and capital grants and amounted EUR 2.2m as per end of 2016. Other current assets included accrued grant income and deferred charges and increased in 2016 to EUR 1.9m compared to EUR 1.3m in 2015. The Company's cash and cash equivalents end of 2016 amounted to EUR 83.2m compared to EUR 104.1m end of 2015. Total financial debt amounted to EUR 31.4m as per end of 2016, representing an increase of EUR 20.6m compared to the EUR 10.8m of total financial debt outstanding end of 2015. The increase is for EUR 12.6m related to obtained lease financing for the funding of investments for Biocartis' current and second cartridge manufacturing line. Furthermore, EUR 8.1m is related to the new subordinated loan of EUR 15.0m that the Company attracted in July 2016 to refinance an existing subordinated loan (nominal amount of EUR 5m, excluding accrued interest charges) that was due end of 2016. The current portion of financial debt as per 31 December 2016 amounted to EUR 3.7m and the non-current portion to EUR 27.7m. Trade payables end of 2016 amounted to EUR 6.3m, representing a decrease of EUR -7.6m compared to the EUR 13.9m that was outstanding end of 2015. This decrease was predominantly driven by invoices received in 2015 for manufacturing expansion that were paid for in 2016. Deferred income decreased in 2016 to EUR 2.1m (EUR 5.2m end of 2015), mainly because of recognized upfront payments from Janssen Pharmaceutica in relation to the strategic licensing, development and commercialization collaborations. Cash flow statement The cash flow from operating activities amounted to EUR -53.4m in 2016 compared to EUR -27.3m in 2015 driven by an increased loss for the period (predominantly due to higher operational expenses) in combination with investments in working capital in 2016 compared to significant positive moments in working capital for 2015. The cash flow from investing activities in 2016 amounted to EUR -9.3m compared to EUR -5.4m in 2015 principally driven by increased investments for the cartridge manufacturing expansion and higher investments in intangible assets, mainly consisting of software and IP licenses. The cash flow from financing activities in 2016 amounted to EUR 41.8m driven by the net proceeds from the private placement in November 2016 and proceeds from new borrowings, as well as the proceeds received from the Company's lease financing provider related to manufacturing equipment that was initially paid for by Biocartis and afterwards re-financed with lease financing. The cash flow from financing activities in 2015 amounted to EUR 125.9m, which was exceptionally impacted by the net proceeds from the Company's IPO in April 2015. Driven by the aforementioned, the total net cash flow in 2016 amounted to EUR -20.9m compared to EUR 93.2m in 2015. Webcast and presentation Biocartis will host a conference call with live webcast, during which the 2016 results will be presented, followed by a Q&A session. This event will be held today, 2 March 2017 at 14:00 CET / 13:00 BST (UK) / 08:00 EDT (US). Access the webcast by clicking here. If you would like to participate in the Q&A, please dial +44(0)20 3427 1901 (standard international) with confirmation code 9539312. A replay of the webcast will be available on the Biocartis investors' website shortly after. Financial information The consolidated financial statements have been prepared in accordance with IFRS, as adopted by the EU. The financial information included in this press release is an extract from the full IFRS consolidated financial statements, which will be published on 30 March 2017. The statutory auditor, Deloitte Bedrijfsrevisoren /Reviseurs d'Entreprises, represented by Gert Vanhees, has substantially completed the audit procedures on the IFRS consolidated statements as of and for the year ended 31 December 2016, and has confirmed that the consolidated balance sheet, the consolidated statements of comprehensive income, cash flow and changes in shareholders' equity, included in this press release, are consistent in all material aspects with the consolidated accounts from which they have been derived. Please find an overview of the Consolidated Income Statement, the Consolidated Balance Sheet, the Consolidated Cash Flow Statement and the Consolidated Statement of Changes in Shareholder Equity in the full version of the press release in attachment. About Biocartis  Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla(TM) platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis launched the Idylla(TM) platform in 2014. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest growing and largest segments of the MDx market worldwide. Today, Biocartis has eight oncology tests and two infectious disease tests in its product menu. More information: www.biocartis.com Press Photo Library available here. Follow us on Twitter: @Biocartis_. Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors' current expectations and projections concerning future events such as the Company's results of operations, financial condition, liquidity, performance, prospects, growth, strategies and the industry in which the Company operates. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future.  In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. [1] See further under 'Performance studies'. An overview of the publications can be found on www.biocartis.com. [2] The collaboration announced on 3 February 2016 focused on selected reference hospitals in Brazil, Canada, Colombia, Mexico, Saudi Arabia, Spain and Turkey. [3] The collaboration does not include the US, China and Japan. [4] It concerns a new set of mutations in the EGFR ectodomain. While the commonly known EGFR mutations reside in the kinase domain of the EGFR receptor, which is located inside the cell, the EGFR ectodomain is the portion of the receptor located outside the cell, and represents the true receptor function where EGF binds, and where anti-EGFR antibodies for the treatment of colorectal cancer such as cetuximab and panitumumab engage the EGFR receptor and prevent EGF binding. [5] The analysis is done based on a slice of FFPE (formalin fixed paraffin embedded) tumor. [6] Janku et al. BRAF Mutation Testing in Cell-Free DNA from the Plasma of Patients with Advanced Cancers Using a Rapid, Automated Molecular Diagnostics System. Mol Cancer Ther (2016) 15(6): 1-8; Schreuer et al. Quantitative assessment of BRAF V600 mutant cell-free tumor DNA from plasma as a diagnostic and therapeutic biomarker in patients with BRAF V600 mutant melanoma. ASCO 2015; De Biase et al. 'Fully Automated PCR detection of KRAS Mutations on Pancreatic Endoscopic Ultrasound Fine Needle Aspirates'. J Clin Pathol 2016; Reijans et al. ESMO 2016, published on 6 October 2016; De Luca et al., J Clin Pathol 2016; J.L. Sherwood et al., KRAS - ESMO Abstract 91 P: "Implications of key differences across 12 KRAS mutation detection technologies and their relevance in clinical practice", publically available on https://cslide.ctimeetingtech.com/library/esmo/browse/itinerary/5286/2016-10-10#2z95w; Ellen Vercauteren et al., NRAS - ESMO Abstract 1175P: "Ultra-rapid, sensitive, and fully automated extended RAS testing for metastatic colorectal cancer - evaluation of an NRAS/BRAF/EGFR492 module", publically available on https://cslide.ctimeetingtech.com/library/esmo/browse/itinerary/5286/2016-10-10#2z95w Preliminary Performance Study based on Research data. Martin Reijans et al., EGFR - ESMO Abstract 1173P: "Fully automated and sensitive detection of EGFR exon 18, 19, 20 and 21 mutational status in less than 2.5 hours from a single FFPE slice", publically available on https://cslide.ctimeetingtech.com/library/esmo/browse/itinerary/5286/2016-10-10#2z95w Jérôme Solassol et al., "Multi-Center Evaluation of the Fully Automated PCR-Based Idylla(TM) KRAS Mutation Assay for Rapid KRAS Mutation Status Determination on Formalin-Fixed Paraffin-Embedded Tissue of Human Colorectal Cancer", available for download: http://journals.plos.org/plosone/article/asset?id=10.1371/journal.pone.0163444.PDF [7] James L. Sherwood, "Implications of Key Differences Across 12 KRAS Mutation Detection Technologies and Their Relevance in Clinical Practice", first presented at ESMO in October 2016. [8] Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). [12] Disruptions in DNA repair pathways predispose cells to accumulating DNA damage. A growing body of evidence indicates that tumors accumulate progressively more mutations in DNA repair proteins as cancers progress. DNA repair mechanisms greatly affect the response to cytotoxic treatments, so understanding those mechanisms and finding ways to turn dysregulated repair processes against themselves to induce tumor death is the goal of all DNA repair inhibition efforts. Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4125008/, last updated on 14 February 2017.


Frost & Sullivan hosts a complimentary briefing discussing new growth opportunities unveiled by paradigm shifts in direct to Consumer Testing and Point of care Molecular Diagnostics markets The Global In vitro diagnostics (IVD) industry is being disrupted due to the integration of multi-disciplinary capabilities in biology, chemistry and computational power that companies can leverage to develop new solutions to diagnose, treat and manage chronic disease conditions such as cancer, cardiovascular diseases and diabetes. There is an immense pressure on companies to build new competencies in product development, manufacturing and distribution of new technology platforms such as point-of-care molecular diagnostics and capture new growth opportunities in the precision medicine market. Shifting payment models are transforming the IVD industry. "As healthcare industry moves away from the fee-for-service model, it is more important than ever to understand how your company's product or solution fits into patient care continuum and why it's valuable to clinicians and patients. Reimbursement strategy must be a top priority for IVD companies," said Harry Glorikian, Board Advisor of Nuclelis, Evidation Health, GeneNews. "The rapid adoption of clinical Next-generation sequencing platforms and companion diagnostics applications is set to catalyze improvement in the precision medicine landscape," noted Nitin Naik, Global Life Sciences Vice President at Frost & Sullivan. In Vitro Diagnostics is also opening new revenue streams for non-healthcare companies in the Telecommunications and Health Information Technology areas that are willing to partner with diagnostics companies. "IVD vendors focus on integration, miniaturization and consumerization of diagnostic products.  On the other hand, IT companies and original equipment manufacturers (OEMs) help with the interoperability and data management to create a more patient-centric ecosystem," said Unmesh Lal, Life Sciences Program Manager at Frost & Sullivan. "M&A's will continue to grow in the area of point of care testing and liquid biopsy. Tier 1 companies will be seen making strategic acquisitions in the market for the most promising technologies," noted Divyaa Ravishankar, Senior Industry Analyst, Life Sciences at Frost & Sullivan. To attend the webinar, please click or email Mariana Fernandez, Corporate Communications: Join Frost & Sullivan's Clinical Diagnostics experts, as they present insights on Lab Automation , Shift to Data-Driven Healthcare and Consumer centric Lab Testing. The team will also offer specific  perspectives on Changing Reimbursement Models and Regulations and Investing in Unifying Technologies. The presentation will be followed by a live Question & Answer session. Why You Should Attend: Frost & Sullivan, the global Growth Partnership Company, has spent more than 50 years guiding our clients toward transformational growth strategies. We focus on innovation opportunities driven by disruptive technologies, mega trends, emerging markets and new business models. Through our Growth Partnership model, we collaborate with clients to leverage visionary innovation that takes advantage of our convergence expertise, an experiential learning platform, 360-degree industry coverage and complete global perspective. Is your organization prepared for the next profound wave of industry disruption, increasing competitive intensity, breakthrough best practices, changing customer dynamics and emerging economies? Contact us: Start the discussion


News Article | February 15, 2017
Site: www.prnewswire.co.uk

Frost & Sullivan hosts a complimentary briefing discussing new growth opportunities unveiled by paradigm shifts in direct to Consumer Testing and Point of care Molecular Diagnostics markets The Global In vitro diagnostics (IVD) industry is being disrupted due to the integration of multi-disciplinary capabilities in biology, chemistry and computational power that companies can leverage to develop new solutions to diagnose, treat and manage chronic disease conditions such as cancer, cardiovascular diseases and diabetes. There is an immense pressure on companies to build new competencies in product development, manufacturing and distribution of new technology platforms such as point-of-care molecular diagnostics and capture new growth opportunities in the precision medicine market. Shifting payment models are transforming the IVD industry. "As healthcare industry moves away from the fee-for-service model, it is more important than ever to understand how your company's product or solution fits into patient care continuum and why it's valuable to clinicians and patients. Reimbursement strategy must be a top priority for IVD companies," said Harry Glorikian, Board Advisor of Nuclelis, Evidation Health, GeneNews. "The rapid adoption of clinical Next-generation sequencing platforms and companion diagnostics applications is set to catalyze improvement in the precision medicine landscape," noted Nitin Naik, Global Life Sciences Vice President at Frost & Sullivan. In Vitro Diagnostics is also opening new revenue streams for non-healthcare companies in the Telecommunications and Health Information Technology areas that are willing to partner with diagnostics companies. "IVD vendors focus on integration, miniaturization and consumerization of diagnostic products.  On the other hand, IT companies and original equipment manufacturers (OEMs) help with the interoperability and data management to create a more patient-centric ecosystem," said Unmesh Lal, Life Sciences Program Manager at Frost & Sullivan. "M&A's will continue to grow in the area of point of care testing and liquid biopsy. Tier 1 companies will be seen making strategic acquisitions in the market for the most promising technologies," noted Divyaa Ravishankar, Senior Industry Analyst, Life Sciences at Frost & Sullivan. To attend the webinar, please click or email Mariana Fernandez, Corporate Communications: Join Frost & Sullivan's Clinical Diagnostics experts, as they present insights on Lab Automation , Shift to Data-Driven Healthcare and Consumer centric Lab Testing. The team will also offer specific  perspectives on Changing Reimbursement Models and Regulations and Investing in Unifying Technologies. The presentation will be followed by a live Question & Answer session. Why You Should Attend: Frost & Sullivan, the global Growth Partnership Company, has spent more than 50 years guiding our clients toward transformational growth strategies. We focus on innovation opportunities driven by disruptive technologies, mega trends, emerging markets and new business models. Through our Growth Partnership model, we collaborate with clients to leverage visionary innovation that takes advantage of our convergence expertise, an experiential learning platform, 360-degree industry coverage and complete global perspective. Is your organization prepared for the next profound wave of industry disruption, increasing competitive intensity, breakthrough best practices, changing customer dynamics and emerging economies? Contact us: Start the discussion


Sepsis is a life threatening condition caused by the host immune system response for the infection caused by bacterial, viral, fungal, parasitic organisms. It occurs when the immune system gets activated due to the invasion of the bacteria to respond to that infection and then there is a release of chemicals by the immune system to treat the infection. This chemical enters in the blood stream and this causes inflammation in the body which causes clots and leakage in blood vessels which deprives the vital activity of the organs and other body parts. This disease is caused in 3 different stages which starts with sepsis, leading to severe sepsis, and finally septic shock, which is considered as a medical emergency. Due to the rise in hospital acquired infections and improved technology to for the treatment of sepsis will help in driving the growth of the market. On the basis of technology the market will be segmented into Molecular Diagnostics, Biomarkers, and Immunoassays among others. The molecular techniques can be applied directly on whole blood samples. They are the best choice for rapid identification of a microorganism in the blood. The main advantages of PCR detection directly from the blood are the increased sensitivity and the avoidance of time-consuming culture. This results in substantial reduction in turnaround time even compared with PCR identification from positive blood cultures. The global sepsis diagnostics market is expected to grow at a CAGR of ~8% during the period 2016 to 2022. • bioMérieux, Inc. (US), • EKF Diagnostics (UK), • Immunexpress (US), • T2 Biosystems, Inc. (US), • Sandstone Diagnostics, Inc. (US) • Becton, Dickinson and Company (US), • Axis-Shield Diagnostics Ltd. (Scotland), • Cube Dx GmbH (Austria), Technological advances in the field of diagnostics along with increasing need for quick and accurate results. Moreover, inclination of doctors towards molecular diagnostic techniques for diagnosis are factors which will boost the growth of the Sepsis diagnostics market. Taste the market data and market information presented through more than 30 market data tables and figures spread over 110 numbers of pages of the project report. Avail the in-depth table of content TOC & market synopsis on “Sepsis Diagnostics Market Research Report- Global Forecast to 2022”. The Global Sepsis Diagnostics Market has been evaluated as a growing market and it is expected that the market will touch high growth figures in future. Factors such the growing prevalence of chronic dieses like AIDS, cancer, diabetes among others will drive the growth of the market. The global Sepsis Diagnostics market is expected to grow with CAGR of ~8% during the forecasted period. Depending on geographic region, Sepsis Diagnostics market is segmented into four key regions: North America, Europe, Asia Pacific, and Middle East & Africa. Globally North America is the largest market for sepsis diagnostics as they deploy the most advanced healthcare technologies and increasing demand for the reliable and cost effective products. Europe is the second-largest market for clinical trial management system. Asia pacific region is expected to be fastest growing region in Sepsis Diagnostics market due to increasing healthcare expenditure. Global sepsis diagnostics market has been segmented on the basis of techology which comprises of molecular diagnostics, biomarkers, immunoassays and others. On the basis of type of product; market is segmented into kits, instruments, blood culture media and others. On the basis of end users; market is segmented into pathology laboratories, specialty clinics, hospitals, diagnostic centers and others. The report of global sepsis diagnostics market by Market Research Future comprises of extensive primary research along with detail analysis of qualitative as well as quantitative aspects by various industry experts and key opinion leaders to gain a deeper insight of the market and industry performance. Brief TOC 1 Introduction 1.1 Definition 1.2 Scope of Study 1.3 Research Objective 1.4 Assumptions & Limitations 1.5 Market Structure: 2 Research Methodology 2.1 Research Process 2.2 Primary Research 2.3 Secondary Research 3 Market Dynamics 3.1 Drivers 3.2 Restraints 3.3 Opportunities 3.4 Challenges 3.5 Macroeconomic Indicators 4 Market Factor Analysis 4.1 Porter’s five forces model 4.1.1 Bargaining Power of suppliers 4.1.2 Bargaining Power of Customer 4.1.3 Intensity of Competitor’s 4.1.4 Threat of New Entrants 5 Global Sepsis Diagnostics Market, by Technology Continued…. Spinal implants market information, by type (fusion implants, non-fusion implants), by procedure (open surgery, minimally invasive surgery) by material (titanium, titanium-alloy, stainless steel, and plastic) - Forecast till 2022 At Market Research Future (MRFR), we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Raw Research Reports (3R), Continuous-Feed Research (CFR), and Market Research & Consulting Services. MRFR team have supreme objective to provide the optimum quality market research and intelligence services to our clients. Our market research studies by products, services, technologies, applications, end users, and market players for global, regional, and country level market segments, enable our clients to see more, know more, and do more, which help to answer all their most important questions. For more information, please visit https://www.marketresearchfuture.com/reports/sepsis-diagnostics-market


News Article | February 16, 2017
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SAN FRANCISCO & ST. LOUIS--(BUSINESS WIRE)--Cofactor Genomics, a software-driven biotechnology company developing unique molecular diagnostics centered on RNA, has launched a clinically-validated oncology assay which provides unique insight into a patient’s cancer profile. The assay, named Cofactor Pinnacle, utilizes the company’s proprietary software technology to compare each patient’s cancer expression profile to Cofactor’s database of thousands of expression profiles from the same cancer type. The assay reports on both aberrant oncology-relevant gene expression and known cancer gene fusions detected in the tumor sample. In 2016, after multi-year efforts to standardize and certify Cofactor’s foundational molecular protocols for clinical use, Cofactor became one of the first laboratories to receive CAP-accreditation for RNA-seq. Pinnacle is built on the foundation of these protocols; the assay is currently approved for use with Formalin-Fixed, Paraffin-Embedded (FFPE) tumor tissue. Cofactor has secured early-access partnerships for the assay within two key groups: drug developers and academic medical centers. Within the drug development pipeline, Pinnacle is being used to identify new patient populations and explain phenotypic responses in trials. In the clinic, Cofactor Pinnacle is providing potential treatment targets for patients who have not responded to first or second line chemotherapy. “Clinical oncology has relied so heavily on the development of DNA assays, but there’s still a biological gap to be addressed. Recognizing RNA’s ability to identify relevant targets in cancer drug development, as well as more accurately predict the correct treatment for cancer patients, are the key reasons we have built a company committed to developing technologies to interpret the complex data represented by RNA. Cofactor’s Pinnacle adds valuable biological context that’s needed and currently missing from oncology assays,” noted Cofactor CEO, Dr. Jarret Glasscock. Pinnacle is offered as a laboratory-developed test exclusively through Cofactor’s CAP-accredited laboratories. Pinnacle will be featured at CHI’s 24th International Molecular Med TRI-CON 2017. Jon Armstrong, Cofactor’s CSO will present "Reaching the Pinnacle: A Unique Cancer Diagnostic Tool that Harnesses the Power of RNA" on Tuesday, February 21 at 11:45 am - 12:15 pm in the Molecular Diagnostics track. Cofactor Genomics uses RNA to diagnose disease. Y Combinator backed Cofactor is founded by three former Human Genome Project molecular and data scientists who are developing key technologies to enable RNA’s use in understanding and diagnosing disease in the 95 percent of disease that can’t be diagnosed with DNA alone. Cofactor has contracts with eight of the world’s largest pharma and biotech companies, providing pre-clinical RNA sequencing and analysis, custom assay development, and clinical RNA sequencing. With the acquisition of Narus Biotechnologies in 2015 and a fully-funded Phase II SBIR grant, Cofactor has expanded into the molecular diagnostics arena, centered on oncology and neurodegenerative diseases. Find out more about Cofactor Genomics at cofactorgenomics.com.


An infusion system is a device, and any associated disposables, used to deliver fluids or drugs in solution to the patient. The common routes are: intravenous, subcutaneous, epidural or enteral. The simplest devices, gravity controllers, employ a clamping action to vary the flow of liquid under the force of gravity. More complex systems use a positive pumping action for infusion. The infusion systems are used in almost all the treatments. The infusion systems are required in high volume on a daily basis. As the number of clinics and hospitals is increasing globally, the requirement of the infusion systems will increase multiple times. • Baxter International, Inc. (U.S.) • Smiths Medical (U.S.) • Medtronic, Inc. (U.S.) • Roche Holdings Ltd. (Switzerland) • Pfizer Inc. (U.S.) • Johnson & Johnson (U.S.) • CareFusion Corporation (U.S.) • ICU Medical Inc. (U.S.) Global infusion systems Market has been segmented on the basis of product types which comprises of ambulatory pumps, I.V. disposables, syringe pump systems, volumetric pump sets and others. On the basis of application, market is classified into chemotherapy, cardiovascular diseases, Diabetes, Pediatrics and others. On the basis of end users, market is segmented into Hospitals, Clinics, Research laboratories and others. The report for Global Infusion Systems Market of Market Research Future comprises of extensive primary research along with the detailed analysis of qualitative as well as quantitative aspects by various industry experts, key opinion leaders to gain the deeper insight of the market and industry performance. Taste the market data and market information presented through more than 50 market data tables and figures spread in 130 numbers of pages of the project report. Avail the in-depth table of content TOC & market synopsis on “Global Infusion Systems Market Research Report- Forecast To 2027” • To provide detailed analysis of the market structure along with forecast for the next 10 years of the various segments and sub-segments of the Infusion Systems Market • To provide insights about factors affecting the market growth • To Analyze the Infusion Systems Market based on various factors- price analysis, supply chain analysis, porters five force analysis etc. • To provide historical and forecast revenue of the market segments and sub-segments with respect to four main geographies and their countries- Americas, Europe, Asia, and Rest of World. • To provide country level analysis of the market with respect to the current market size and future prospective • To provide country level analysis of the market for segments by type, by application, by end users and sub-segments. • To provide overview of key players and their strategic profiling in the market, comprehensively analyzing their core competencies, and drawing a competitive landscape for the market • To track and analyze competitive developments such as joint ventures, strategic alliances, mergers and acquisitions, new product developments, and research and developments in the Global Infusion Systems Market. Americas • North America • US • Canada • Latin America Europe • Western Europe • Germany • France • Italy • Spain • UK • Rest of Western Europe • Eastern Europe Asia– Pacific • Asia • China • India • Japan • South Korea • Rest of Asia • Pacific The Middle East& Africa The report gives the clear picture of current market scenario which includes historical and projected market size in terms of value and volume, technological advancement, macro economical and governing factors in the market. The report provides details information and strategies of the top key players in the industry. The report also gives a broad study of the different markets segments and regions Global Molecular Diagnostics Market Information by technique types (polymerase chain reaction, spectral karyotype imaging) by application (diseases, oncology, pharmacogenomics, genetic disease screening, human leukocyte antigen typing, coagulation, others) by end users (Laboratories, Hospitals, Academic Institutes) - Forecast to 2027 At Market Research Future (MRFR), we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Raw Research Reports (3R), Continuous-Feed Research (CFR), and Market Research & Consulting Services. MRFR team have supreme objective to provide the optimum quality market research and intelligence services to our clients. Our market research studies by products, services, technologies, applications, end users, and market players for global, regional, and country level market segments, enable our clients to see more, know more, and do more, which help to answer all their most important questions. For more information, please visit https://www.marketresearchfuture.com/reports/infusion-systems-market


ROCKVILLE, Md., March 1, 2017 /PRNewswire/ -- The market for nucleic acid tests (NAT) used in blood donation screening is constrained by stagnant or declining transfusion rates in the developed world. As reviewed in The World Market for Molecular Diagnostics, 7th Edition, from market resea...


Molecular diagnostics is a collection of technical systems used to examine biological markers in the genome and proteome of the individual's hereditary code and how their cells express their qualities as proteins by applying sub-atomic biology to therapeutic testing. Get Sample copy of this Report @ https://www.marketresearchfuture.com/sample_request/1171 Global Molecular Diagnostics Market has been segmented on the basis of applications which consist of infectious diseases, oncology, pharmacogenomics, genetic disease screening, human leukocyte antigen typing, and coagulation. On the basis of technique type which includes polymerase chain reaction (PCR), fluorescent in situ hybridization (FISH), spectral karyotype imaging (SKI), and DNA chip technology. On the basis of end users which includes Laboratories, Hospitals, Academic Institutes and others The report for Global Molecular Diagnostics Market of Market Research Future comprises of extensive primary research along with the detailed analysis of qualitative as well as quantitative aspects by various industry experts, key opinion leaders to gain the deeper insight of the market and industry performance. Taste the market data and market information presented through more than 50 market data tables and figures spread in 115 numbers of pages of the project report. Avail the in-depth table of content TOC & market synopsis on “Global Molecular Diagnostics Market Research Report- Forecast To 2027" • To provide detailed analysis of the market structure along with forecast for the next 10 years of the various segments and sub-segments of the Global Molecular Diagnostics Market • To provide insights about factors affecting the market growth • To Analyze the Global Molecular Diagnostics Market based on various factors- price analysis, supply chain analysis, porters five force analysis etc. • To provide historical and forecast revenue of the market segments and sub-segments with respect to four main geographies and their countries- Americas, Europe, Asia, and Middle East & Africa • To provide country level analysis of the market with respect to the current market size and future prospective • To provide country level analysis of the market for segments by technique type, by application, by end users and sub-segments. • To provide strategic profiling of key players in the market, comprehensively analyzing their core competencies, and drawing a competitive landscape for the market • To track and analyze competitive developments such as joint ventures, strategic alliances, mergers and acquisitions, new product developments, and research and developments in the Global Molecular Diagnostics Market The report gives the clear picture of current market scenario which includes historical and projected market size in terms of value and volume, technological advancement, macro economical and governing factors in the market. The report provides details information and strategies of the top key players in the industry. The report also gives a broad study of the different markets segments and regions Global Pharmacogenomics Market Information by Application (drug safety, Tailor treatments, drug discovery), By Therapeutic application (cancer, oncology, cardiovascular) By Methods (haplotype analysis, multivariate techniques) - Forecast to 2027 https://www.marketresearchfuture.com/reports/pharmacogenomics-market At Market Research Future (MRFR), we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Raw Research Reports (3R), Continuous-Feed Research (CFR), and Market Research & Consulting Services. MRFR team have supreme objective to provide the optimum quality market research and intelligence services to our clients. Our market research studies by products, services, technologies, applications, end users, and market players for global, regional, and country level market segments, enable our clients to see more, know more, and do more, which help to answer all their most important questions. For more information, please visit https://www.marketresearchfuture.com/reports/molecular-diagnostics-market


DUBLIN, Feb 17, 2017 /PRNewswire/ -- Research and Markets has announced the addition of the "Global Point of care Molecular Diagnostics Market Analysis & Trends - Technology, Test Location, Application - Forecast to 2025" report to their offering. Some of the prominent...

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