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The current invention concerns a method for identifying the presence of a cancer and/or an increased risk of a cancer in a mammal, by calculating a parameter obtained from a biological sample whereby said cutoff value is a prerequisite for the presence or absence of one or more aneuploidies in said target chromosome or chromosome segment which is an indicator of the presence and/or increased risk of cancer.


The current invention describes a method for determining the presence or absence of a fetal chromosomal aneuploidy in a pregnant female, the method comprising the calculation of a parameter p from sequences obtained from a biological sample from said pregnant female. The current invention equally provides a method for determining the fetal fraction of said sample.


News Article | May 10, 2017
Site: globenewswire.com

Mechelen, Belgium, 10 May 2017 - Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), is pleased to announce Herman Verrelst as its new Chief Executive Officer (CEO), effective as of August 2017. Herman is a seasoned executive and serial entrepreneur with a proven international commercial track-record in molecular diagnostics. Herman currently holds the position of Vice President and General Manager of the Genomics and Clinical Applications Division of Agilent Technologies Inc. (NYSE: A), a global leader in life sciences, diagnostics and applied chemical markets with revenues of USD 4.2 billion in 2016. In this role, Herman has been instrumental in expanding Agilent's product portfolio through product innovations and the addition of new technologies. These were primarily in the area of precision genomics for oncology, the gateway to precision medicine, which is an excellent background to assist Biocartis in accelerating its worldwide commercial expansion and test menu development. Herman joined Agilent in May 2015 as General Manager of the Clinical Applications Division following Agilent's acquisition of Cartagenia, of which Herman was CEO and founder. Cartagenia was a spin-off of Katholieke Universiteit Leuven (Belgium) and was focused on software solutions for clinical genetics and molecular oncology. Prior to that, Herman was CEO of Medicim, which was acquired by the Swiss-based Nobel Biocare AG in 2007, as well as founder and CEO of DATA4s, which was acquired by Norkom Technologies Ltd. in 2004. Herman holds a Master's degree in Electrical Engineering (Katholieke Universiteit Leuven, Belgium). Rudi Mariën, Chairman of Biocartis, commented: "It is with great excitement that we today announce that Herman will be appointed as our new CEO. Herman has demonstrated true leadership in his previous positions where he realized impressive commercial and shareholder successes. I am confident that under the leadership of Herman, Biocartis will excel in its next phase of growth. We congratulate Herman and wish him all the best in his new role." Herman Verrelst added: "I am passionate by growth stories that are driven by true innovation and as such very pleased to be given the opportunity to join Biocartis. I look forward to work with the team and with Rudi Pauwels, whose passion and vision I share, to continue to disrupt the molecular diagnostics market with solutions that bring precision medicine into practice. The Idylla(TM) platform is an extremely elegant and best-in-class platform to achieve this goal." Rudi Pauwels, founder of Biocartis, and Hilde Windels, interim CEO, commented: "We are convinced that Herman's commercial track-record, industry experience and personality are a perfect fit for this leadership role within Biocartis. We look forward to work with Herman and to further execute our plans, making sure that Biocartis can impact on a global scale the way molecular diagnostics is performed." 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 with a primary focus oncology followed by 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.


News Article | May 10, 2017
Site: globenewswire.com

Mechelen, België, 10 mei 2017 - Biocartis Group NV (de 'Vennootschap' of 'Biocartis'), een innovatief bedrijf in de moleculaire diagnostiek (Euronext Brussels: BCART), is verheugd om Herman Verrelst aan te kondigen als zijn nieuwe Chief Executive Officer (CEO) vanaf augustus 2017. Herman is een geroutineerd executive en seriële ondernemer met een bewezen internationaal commercieel track-record in moleculaire diagnostiek. Herman bekleedt momenteel de positie van Vice President en General Manager van de afdeling 'Genomics and Clinical Applications' van Agilent Technologies Inc. (NYSE: A), een wereldwijde leider in life sciences, diagnostiek en toegepaste chemische markten met een omzet van USD 4,2 miljard in 2016. In deze rol was Herman essentieel voor de uitbreiding van Agilent's productportfolio door productinnovaties en de toevoeging van nieuwe technologieën. Deze situeerden zich voornamelijk in het domein van genomische precisie-oncologie, de poort naar precisie geneeskunde, hetgeen een ideale achtergrond is om Biocartis te ondersteunen in de versnelling van zijn wereldwijde commerciële expansie en ontwikkeling van zijn menu aan testen. Herman vervoegde Agilent in mei 2015 als General Manger van de afdeling Clinical Applications, volgend op Agilent's acquisitie van Cartagenia waarvan Herman CEO en stichter was. Cartagenia was een spin-off van de Katholieke Universiteit Leuven (België) en was gericht op software-oplossingen voor klinische genetische en moleculaire oncologie. Daarvoor was Herman CEO van Medicim, dat overgenomen werd door het in Zwitserland gebaseerde Nobel Biocare AG in 2007, alsmede stichter en CEO van DATA4s dat overgenomen werd door Norkom Technologies Ltd. in 2004. Herman heeft een Master diploma Ingenieurswetenschappen (Katholieke Universiteit Leuven, België). Rudi Mariën, Voorzitter van Biocartis, reageerde: "Vandaag kondigen we met veel enthousiasme Herman aan als onze nieuwe CEO. Herman heeft echt leiderschap getoond in zijn vorige functies, waar hij indrukwekkende commerciële- en aandeelhouderssuccessen realiseerde. Ik heb er alle vertrouwen in dat Biocartis onder het leiderschap van Herman zal uitblinken in zijn volgende groeifase. We willen Herman dan ook feliciteren en hem alle succes toewensen in zijn nieuwe rol." Herman Verrelst voegde hieraan toe: "Ik heb een passie voor groeiverhalen, gedreven door echte innovatie, en ben daarom ook erg blij dat ik de kans krijg om Biocartis te vervoegen. Ik kijk er naar uit om te werken met het team en met Rudi Pauwels, wiens passie en visie ik deel, om te blijven innoveren in de moleculaire diagnosemarkt met oplossingen die precisie geneeskunde in de praktijk brengen. Het Idylla(TM) platform is een uiterst elegant en best-in-class platform om dit doel te bereiken." 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 september 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.


Grant
Agency: European Commission | Branch: FP7 | Program: CSA-SA | Phase: HEALTH.2013.4.1-4 | Award Amount: 553.89K | Year: 2013

The landscape of genetic testing is rapidly changing. Soon, whole genome sequence analysis (3Gb-testing) will be an effective and financially viable alternative to targeted gene analysis. New technologies that allow efficient sequencing of a whole human genome in a diagnostic setting will have an enormous impact on diagnostic centres replacing many existing molecular and cytogenetic tests. Patients deserve to benefit from our vastly growing knowledge on functional genomics. 3Gb-testing is the ideal method to bring these benefits to the public. However, it is critical to avoid mistakes with respect to ethics, quality, over or mis-interpretation of data. It is essential that our society is prepared for the change once it is implemented. Hence, current gaps in our knowledge have to be identified and research has to be initiated to bridge these gaps. The 3Gb-TEST project will bring stakeholders together and ensure they are informed with respect to the desirable and undesirable developments. The clinical utility and cost effectiveness of whole genome sequencing needs to be determined as part of a robust health technology assessment process (HTA). Interpretation of sequence data in terms of clinical relevance will pose a challenge to both laboratory and clinical geneticists. Substantial investments may be required and the logistic restructuring of genetic services will need to be addressed. This project aims to prepare Europe for innovations in molecular testing. Quality assessment schemes, HTA and guidelines have to be in place. Healthcare professionals must be aware of the impending change and potential impact on practice. The Consortium will inform the healthcare community and make recommendations to the European Commission, the European Society of Human Genetics, and national organizations relevant to this field. A key output will be a validated roadmap for the implementation of diagnostic genome sequencing in Europe.


Grant
Agency: European Commission | Branch: H2020 | Program: CSA | Phase: HCO-15-2014 | Award Amount: 1.20M | Year: 2015

The Genetics Clinic of the Future (GCOF) project aims to ensure that the clinical implementation of genome technologies is relevant and responsive to the needs of all. It offers a stepping stone approach towards the genetics clinic of the future, engaging all stakeholders involved in a process of mutual learning and information exchange. The GCOF project implements key Science with and for Society issues, ensuring that ethical reflection and stakeholder involvement do not occur in parallel, but are effectively integrated in the core of the project. It establishes a robust communication and implementation strategy that integrates the projects outcomes and recommendations in research and clinical practices and policy processes, outlining opportunities for a more responsive health research and innovation system by: 1. Envisioning the Genetics Clinic of the Future (WP1) 2. Mapping out the concept of data control (WP2) 3. Considering ethical and legal dimensions in the consent framework (WP3) 4. Exploring novel models for use of clinical data in research and vice versa (WP4) 5. Initiating public engagement, mutual learning and dissemination (WP5) 6. Engaging policy makers (WP6) The consortium brings together 12 key partners from 10 countries across Europe who represent the breadth of stakeholders involved in the genetics clinic of the future: genomics research, clinical genetics, bioinformatics, public health, policy making, patient representation, education, commercial genetics and bioinformatics services, social research, communication, responsible innovation and ethics and law. The GCOF project connects to the major EU-initiatives in the field of personalised health and care. The consortium also represents a variety of organisation types, including research organisations, businesses, policy makers, civil society organisations, education establishments and science & society centres.


Patent
Cartagenia | Date: 2014-11-10

A method of target DNA genome analysis is provided. The method comprises the steps of: obtaining non-overlapping segments of target DNA stretches with segment boundaries defined by the presence of particular restriction enzyme recognition sites, whereby the assembly of said non-overlapping segments compose a reduced representation library of said target DNA genome; obtaining for said segments, raw metrics from a sequencing process applied on said reduced representation library; clustering non-overlapping, nearby segments with similar raw metrics to provide master segments; providing metrics describing the master segments, making a final discrete DNA call based on the master segments and its metrics.


Healthspan (the life period when one is generally healthy and free from serious disease) depends on nature (genetic make-up) and nurture (environmental influences, from the earliest stages of development throughout life). Genetic studies increasingly reveal mutations and polymorphisms that may affect healthspan. Similarly, claims abound about lifestyle modifications or treatments improving healthspan. In both cases, rigorous testing is hampered by the long lifespan of model organisms like mice (let alone humans) and the difficulty of introducing genetic changes to examine the phenotype of the altered genome. We will develop C. elegans as a healthspan model. Already validated extensively as an ageing model, this organism can be readily modified genetically, and effects of environmental manipulations on healthspan can be measured in days or weeks. Once validated as a healthspan model, it can be used for an initial assessment of preventive and therapeutic measures for humans, as well as for risk identification and the initial evaluation of potential biomarkers. It will also prove useful to study interactions between genetic and various environmental factors.


- Customers of Cartagenia's Bench Lab NGS software platform now have option to access N-of-One Clinical Interpretation uniquely specific to each patient's molecular profile BOSTON, March 17, 2015 /PRNewswire/ -- Cartagenia, leader in providing clinical genetics and pathology labs with variant assessment & reporting support software, today announced a partnership with Lexington, MA-based N-of-One, an industry-leading provider of patient-specific Clinical Interpretation for molecular profiles at the disease, gene and variant level. With the availability of N-of-One's services from within the Bench Lab NGS software platform, pathology genetics laboratories can now integrate N-of-One Clinical Interpretation based on genomic profiling and tumor information into their somatic variant analysis and reporting workflow. N-of-One Clinical Interpretation saves pathologists and physicians hours of research and preparation time per patient, without sacrificing quality. N-of-One Clinical Interpretation delivers scientific and clinical evidence that supports possible therapeutic strategies relevant to each specific patient case. N-of-One Clinical Interpretation can be configured to easily and efficiently integrate into an organization's reporting needs. The N-of-One Clinical Interpretation services are complementary to the capabilities Cartagenia provides with the Bench Lab NGS platform, noted Steven Van Vooren, scientific co-founder of Cartagenia. "No tumor is exactly the same - and N-of-One has a team of experts that provides exactly those deep and patient-specific insights our pathology lab customers need," Van Vooren said. "Labs automate their somatic variant assessment SOPs on our software platform to identify variants that are relevant to further review, and now can look to N-of-One to provide tailored, patient-specific insights that will efficiently support the pathologists in providing physicians with the relevant information regarding drugs, trials and treatment options. Labs can include configurable N-of-One Clinical Interpretation in their lab reports in a single, controlled and supervised workflow." To enable this partnership, Cartagenia has created the infrastructure necessary to integrate a lab's internal knowledge with external information, such as publicly available databases, data shared between collaborating labs, and partner services. Labs can now bring together their proprietary expert knowledge – from their own curation efforts, literature review, and previous findings from other samples – with up-to-date, tailored content on treatment options. Herman Verrelst, Cartagenia's CEO, states: "NGS is rapidly being adopted as a standard test in pathology labs. Our customers derive great value from complementing their internal knowledge bases with up-to-date, high-quality interpretation and insights that help physicians assess treatment options. We are very excited to work with N-of-One as their team of in-house PhD and MD experts deliver industry-leading, clinical and scientific evidence tailored to each cancer patient's molecular profile." "Cartagenia serves a broad customer base of leading clinical genetics and pathology laboratories that value an efficient diagnostic workflow," said Chris Cournoyer, CEO of N-of-One. "We are excited to partner with Cartagenia. The integration of our Clinical Interpretation services into Cartagenia's clinical-grade software platform for variant assessment support will allow clinical laboratories to keep up with the scale and pace of change in knowledge, and support their physicians in patient treatment planning." N-of-One and Cartagenia will promote the partnership by cooperating on marketing initiatives to inform customers of the benefits and advantages of the joint use of each company's solutions. Cartagenia will be showcasing the availability of N-of-One's Clinical Interpretation services through the Bench Lab NGS software platform at the upcoming American College of Medical Genetics annual clinical meeting (ACMG 2015) on March 25-27 at the Salt Palace Convention Center in Salt Lake City, Utah. About Cartagenia Cartagenia supplies variant assessment support and lab report automation software, database systems, and related services to genetic labs, pathology labs and clinicians, enabling them to perform clinically relevant genetic analyses quickly and efficiently, and offer patients and carers high-quality genetic interpretation and counselling. Cartagenia Bench Lab allows automation of variant assessment protocols and lab report generation for structural and molecular variant assays such as Arrays, Sanger and Next Generation Sequencing. It supports communication with referring physicians, allows labs and clinicians to put variants in their clinical context, and supports confident data sharing. The Cartagenia Bench platform is built in collaboration with genetics labs and clinical experts involved in routine medical practice. Because of this, Bench Lab addresses the specific needs of genetic diagnostic labs and clinicians. Cartagenia Bench is built using a certified ISO13485 Quality Management System and is registered with the FDA as an exempt Class I Medical Device in the United States and as a Class I Medical Device in Europe in conformity with the essential requirements and provisions of the Council Directive 93/42/EEC concerning medical devices, and with the relevant harmonized standards EN ISO62304. About N-of-One N-of-One, a leader in enabling precision medicine for oncology, leverages its world-class team of experts coupled with a highly proprietary platform that allows us to provide clinical solutions and services, such as molecular interpretation, to clinicians at the point of care. N-of-One's team of experts has interpreted thousands of samples for oncologists and patients worldwide, through partnerships with leading diagnostic companies, hospital systems, directly to oncologists and through employee access benefit programs. N-of-One does not provide medical advice or promote any product or service. For more information, please visit www.n-of-one.com or call 617-202-9808.


News Article | November 10, 2016
Site: www.businesswire.com

SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today released Cartagenia Bench Lab 5.0, a major new version of its lab software with new capabilities for somatic variant classification and reporting. Cartagenia Bench Lab is designed to help laboratories involved in clinical genetics and molecular pathology efficiently interpret and report on genomic variants. The clinical-grade software platform – registered as an exempt Class I Medical Device in the U.S. – has become

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