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Angels Camp, CA, United States
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Angels Camp, CA, United States

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News Article | May 1, 2017
Site: www.eurekalert.org

Paris, France - 1 May 2017: The risk of heart transplant rejection can be reduced by desensitising patient antibodies, according to research presented today at Heart Failure 2017 and the 4th World Congress on Acute Heart Failure.1 The breakthrough comes on the 50th anniversary of heart transplantation. Before heart transplantation the serum of heart transplant candidates is tested for levels of anti-human leukocyte antigen (HLA) which could bind to donor HLA antigens and cause rejection of the organ. At the time of transplantation, a virtual crossmatch is conducted to determine if the patient's anti-HLA antibodies are directed against the donor's specific HLA antigen -- if yes, they are called "donor specific anti-HLA antibody" (DSA). "Most centres do not perform heart transplantation in patients with a high DSA level since the risk of antibody-mediated rejection is high, particularly hyper-acute rejection," said lead author Dr Guillaume Coutance, a cardiologist at Pitié-Salpêtrière Hospital in Paris, France. "Patients then have to wait for a donor with different HLA antigens." To reduce the chance of rejection in these patients at high immunological risk, in 2009 Pitié-Salpêtrière Hospital began a desensitisation programme. The current study analysed the impact of the programme on survival after heart transplantations performed during 2009 to 2015. The type of desensitisation patients receive depends on their DSA level, which is measured by mean fluorescence intensity (MFI). An MFI between 500 and 1000 is considered "low DSA" and an MFI above 1000 is considered "high DSA". All patients receive anti-thymocyte globulins and conventional immunosuppressive therapy (calcineurin inhibitors, mycophenolate mofetil, and corticosteroids). On top of this, patients with low DSA levels receive intravenous immunoglobulins. Patients with high DSA levels are treated with plasmapheresis before and after transplantation, followed by intravenous immunoglobulins after the complete cycle of plasmapheresis. The study included 523 patients who were 50 years old on average and 77% were men. Nearly half (46%) of patients had no DSA, 17% had low DSA, and 37% had high DSA levels. Patients were followed-up for an average of 3.7 years and survival was compared between the three groups. Compared to patients with no or low DSA, those with high DSA were more often younger, female, and had a ventricular assist device. The length of survival after transplantation was similar between the three groups, even after adjustment for age, sex, and having a ventricular assist device before transplantation. Survival at one year and at the end of follow-up was 79% and 73% for those with no DSA, 80% and 72% in patients with low DSA, and 84% and 76% in patients with high DSA levels, respectively (p=0.85). Antibody-mediated rejections were more common in patients with high DSA levels (27% versus 6% in patients with no DSA). These rejections occurred early (a median of 28 days after transplantation) in patients with high DSA levels but they had no impact on survival and could be treated. Patients with high DSA levels had more bleeding complications due to perioperative plasmapheresis. Dr Coutance said: "By desensitising patient's antibodies, those with high immunological risk experience similar survival to patients without DSA. Pre- and post-operative plasmapheresis results in a dramatic drop in DSA levels, which reduces the risk of hyper-acute rejections and early antibody-mediated rejections. Intravenous immunoglobulins will neutralise DSA for weeks." "Despite this regimen, antibody-mediated rejections were frequent but they were not associated with poor outcomes," added Dr Coutance. "Two factors might explain these good results: early diagnosis of rejection with repetitive routine biopsies, and aggressive treatment of rejections with plasmapheresis and intravenous immunoglobulins even in subclinical rejections. The increased bleeding risk is explained by the loss of coagulation factors during plasmapheresis which is important but does not seem to impact survival." He concluded: "This desensitisation programme could shorten waiting times and increase access to transplantation for patients at high immunological risk. However, it will probably not increase the number of transplantations since donor shortage is the limiting factor."


DUBLIN, May 04, 2017 /PRNewswire/ -- Research and Markets has announced the addition of the "Global HLA Typing Transplant Market 2017-2021" report to their offering. The global HLA typing transplant market to grow at a CAGR of 9.20% during the period 2017-2021. The report,...


Esperite's (Euronext: ESP) biotech subsidiary The Cell Factory develops extracellular vesicles (EVs) biologic drug (CF-MEV-117) for treatment of drug-resistant epilepsy in children. The consortium sponsored by The Cell Factory have achieved an important milestone in the CF-MEV-117 drug development confirming an anti-inflammatory and immunosuppressive activity of the CF-MEV-117 in a dose response manner. Full results will be presented during the International Society for Extracellular Vesicles (ISEV) meeting in Toronto, Canada from 18-21 May, 2017. The Cell Factory, a company of Esperite Group in collaboration with Bambino Gesù Children's Hospital in Rome, Mario Negri Institute for Pharmacological Research in Milan and Women's and Children's Health Department of the University of Padua are developing the EVs drug candidate (CF-MEV-117) for treatment of drug resistant epilepsy in children. The consortium is investigating the immunomodulatory properties of EVs derived from MSCs in several in vitro and in vivo models. It has been demonstrated by independent research groups that inhibitory effects of MSCs on human leukocytes was mediated by secreted EVs. Subsequently, it was demonstrated by our partners that MSC-derived EVs were responsible for inhibition of B-cell proliferation and differentiation and activation of T-cell apoptosis (Budoni et al., 2013; Del Fattore et al., 2015). These results have been recently confirmed with the CF-MEV-117 drug candidate manufactured by The Cell Factory. Preclinical and clinical study demonstrate that brain inflammation could be responsible for severe epileptic seizures. Pro-inflammatory molecules secreted by the stimulated glial cells are responsible for a status epilepticus. Therefore, immunomodulatory and anti-inflammatory treatment focused on astrocytes and microglia cells are reducing or eliminating symptoms of epilepsy and can prevent a relapse of the disease in the future. The project is investigating anti-inflammatory and anti-epileptic effect of the CF-MEV-117 drug candidate in both an acute phase of epilepsy and preventing development of a chronic disease. In addition, we expect that CF-MEV-117 will demonstrate much broader therapeutic effect in neurology influencing neural cells apoptosis, neurons hyperexcitability, and neurogenesis process leading to faster brain regeneration. This will allow using the MSC-derived EVs in treatment of unmet medical needs e.g. stroke, TBI, spinal cord injury. EVs stability and small size are the key advantages allowing their immediate use in acute injuries and the drug penetration through the blood brain barrier. CF-MEV-117 is produced using a proprietary technology developed by The Cell Factory for a large-scale production of ultra-pure EVs, using fully defined, serum-free, xeno-free culture media with no use of animal-derived components and human platelet lysates at any stage of the production process. Production is performed in a closed and scalable stirring bioreactors including a downstream processing based on the integrated sequential filtration system. EVs are continuously secreting by expanded MSCs allowing multiple harvests during one production cycle. This approach significantly reduces the contamination risk, production time, staff, GMP labs use and the cost of goods. Effectively the production of the single EVs dose is now up to 10 times cheaper when comparing to the allogenic MSCs dose equivalent. CF-MEV-117 product is sterilised by filtration during production process what is not possible for any cell therapy products (ATMPs). CF-MEV-117 product has very high batch-to-batch reproducibility. Product analysis is performed using broad range of state-of-the-art techniques i.e. NTA, immunophenotyping, proteomics, among others. Several surface markers have been analysed for CF-MEV-117 product including the tetraspanin transmembrane proteins characteristic for EVs (CD9+, CD63+ and CD81+). Interestingly, CF-MEV-117 EVs do not express HLA-ABC and HLA-DRPQ what increases the drug's safety in human use. The consortium is fully focused on demonstration of the CF-MEV-117 product's anti-inflammatory and immunosuppressive activity and its mode of action. For that purpose T-cells and B-cells have been isolated from human peripheral blood and the cells were stimulated using anti-CD3/CD28 and CpG, respectively. CF-MEV-117 product has increased the activated T reg proliferation and effectively the T reg / T eff ration. In addition, reduction of the activated B cells proliferation and plasma cell differentiation have been observed in response to CF-MEV-117. This confirms previous results obtained using the research-grade EVs. It is worth stressing that the experiments were performed in parallel with the MSCs used for the CF-MEV-117 production. The results have confirmed the same anti-inflammatory effect of the MSCs and the MSC-derived EVs (CF-MEV-117) on stimulated human leukocytes. The CF-MEV-117 drug's effect was observed in a dose responsive manner. The next step is confirmation of the CF-MEV-117 in in vivo models before the clinical translation. EVs including exosomes are nanometre-size, natural biological particles secreted by different types of cells in vivo and in vitro. They contain proteins, growth factors, mRNA and other molecules responsible for the therapeutic effect of MSCs. In addition, EVs have several advantages over allogenic MSCs e.g.: up to 10-times lower production costs, no risk of uncontrolled proliferation and differentiation, lower risk of immune response and easy and safe delivery into different tissues and organs in vivo. High stability allows for easy transport and storage of the "ready-to-use" products. The Cell Factory is developing MSC-EVs drug candidate (CF-MEV-117) for treatment of untreatable-yet acute and chronic drug-resistant epilepsy. Epilepsy carries significant detrimental effects on the quality of life and can lead to a secondary brain damage. The disease can have different etiology, including stroke, brain trauma, and neuro-inflammation. Epilepsy is one of the most common brain diseases affecting about 1 in 100 children under 17-year old according to CDC. Severity of the seizures is variable and the antiepileptic drugs are effective only in about 2/3 of the patients. CDC estimated annual costs related to epilepsy exceeds 15 billion USD in the United States alone. It is expected that EVs products will be effective in treatment of other neuroinflammatory-related injuries of central nervous system. Moreover, EVs will be able to target an acute diseases i.e. TBI, brain stroke, spinal cord injury, more effectively when comparing to allogenic MSCs, due to the EV's stability and easier administration at shorter time what is critical for successful therapy. Diseases of central nervous system are among most devastating for patients and their relatives. Neurological disorders are generating a significant additional cost related to hospitalisation, rehabilitation, often eliminate the patients and their relatives from a job market. CDC estimated that annual costs related to epilepsy exceeds 15 billion USD in the United States alone with 50 million patients worldwide (WHO). Cost related to brain stroke in the United States is estimated to 34 billion USD per year (CDA), with 15 million new patients worldwide each year (WHO). Cumulative cost related to traumatic brain injury (TBI) and spinal cost injury in the United States is over 80 billion USD per year (CDA and AANS), with up to 0.5 million new incidents of spinal cord injury and 10 million of TBI per year (WHO). Most of these diseases have no effective therapy yet. The consortium led by Esperite's The Cell Factory is gathering the leading teams in paediatric regenerative medicine, neurology, gastroenterology, immunology and EVs science. The CF-MEV-107 product is developing in collaboration with Professor Maurizio Muraca's team at the Department of Women's and Children's Health at the University of Padova in Italy. The CF-MEV-117 product is developing in collaboration with Professor Federico Vigevano and Dr Alessandra Fierabracci team at Bambino Gesù Children's Hospital in Rome, Italy and with Dr. Annamaria Vezzani at Mario Negri Institute in Milan, Italy. Frederic Amar, CEO: "The Cell Factory is focused on development, clinical translation and commercialization of the advanced extracellular vesicles (EVs) biologic drugs and autologous stem cell therapies. The Cell Factory goal is to master the development and production of extracellular vesicles drugs in treatment of different indications." ESPERITE Group, listed at Euronext Amsterdam and Paris, is a leading international company in regenerative and predictive medicine established in 2000. The Cell Factory is a biotech company, a subsidy of the Esperite group, developing highest quality therapeutic tools for affordable regenerative medicine. The Cell Factory led by Dr. Marcin Jurga is focused on development, clinical translation and commercialization of the advanced extracellular vesicles (EVs) biologic drugs and autologous stem cell therapies. The Cell Factory goal is to become a leader in development and production of extracellular vesicles drugs in treatment of different indications i.e. graft versus host disease (GvHD) after solid organ and cell transplantations, arthritis, multiple sclerosis, cystic fibrosis, stroke, traumatic brain and spinal cord injury, newborn encephalopathy, and type 1 diabetes among others. The Cell Factory focuses on development of the selected EVs drug candidates from a TRL 4 (non-GLP POC) until TRL 6-7 (Clinical phase II). The Cell Factory is looking for partners and investors who are interested in a rapidly growing, disruptive technology of EVs biological drugs. We are looking for different collaboration models including out-licencing, technology transfer and joint venture product development and dilutive investments. The Cell Factory owns the full rights of a broad international patent family enabling MSC-derived extracellular vesicles (EVs) use in treatment of autoimmune, chronic and acute inflammatory diseases. The patents have been already granted in Europe and recently in China. The Cell Factory is developing the EVs biologic drug products for multiple indications in immunology, neurology and gastroenterology. The leading products are CF-MEV-107 for treatment of Crohn's disease (drug resistant perianal fistulae) and CF-MEV-117 for treatment of drug resistant epilepsy in children. The CF-MEV-107 product is ready for clinical translation and the consortium of leading academic and clinical teams sponsored by The Cell Factory is preparing the CF-MEV-107 product for first in man clinical translation in 2017. To learn more about ESPERITE Group, or to book an interview with CEO Frederic Amar: +31 575 548 998 - ir@esperite.com or visit the websites at www.esperite.com, www.cell-factory.com, www.cryo-save.com and www.genoma.com.


News Article | May 4, 2017
Site: www.businesswire.com

LONDON--(BUSINESS WIRE)--Technavio market research analysts forecast the global human leukocyte antigen (HLA) typing transplant market to grow at a CAGR of more than 9% during the forecast period, according to their latest report. The market study covers the present scenario and growth prospects of the global HLA typing transplant market for 2017-2021. The report also lists systems and software as the two major product segments. According to Srinivas Sashidar, a lead analyst at Technavio for in-vitro diagnostics research, “The increasing demand for organ transplantation has driven the sales of HLA typing tests. The growing incidence of chronic diseases such as kidney disease, end-stage renal disease, coronary artery disease, and acute and chronic hepatitis among all age groups has increased the need for HLA typing to reduce the graft rejection cases.” Technavio’s insights help you make informed business decisions: Buy this report now Technavio reports answer key questions relating to market size and growth, drivers and trends, top vendors, challenges, and more. Their analysts continuously monitor and evaluate the market landscape to help businesses assess their competitive position. Technavio analysts highlight the following three market drivers that are contributing to the growth of the global HLA typing transplant market: The demand for tissue and organs such as bone marrow, heart, liver, kidney, and lungs is very high worldwide. The increasing rate of alcohol consumption, unhealthy lifestyles and food habits, and drug intake are the leading causes of organ failure. In addition, the rise in older adult population results in increased demand for organs for transplantation. According to a combined study conducted by the Department of Internal Medicine, Division of Hepatology, Loyola University Medical Center; Department of Preventive Health Sciences, Stritch School of Medicine, Loyola University Chicago; and Division of Gastroenterology and Hepatology, University of Michigan Health System, in 2015, liver cirrhosis is one of the major factors of death in the US. As a part of the treatment, a person might undergo liver transplantation procedure. For liver recipients, HLA testing is conducted to match the HLAA, HLA B, and HLA DR LOCi. It is safe when the HLA of both organ donor and recipient matches as it reduces the graft rejection cases. The development of new and improved transplantation products, such as organ preservation solution for particular organs, tissue typing technology (HLA typing), and surgical medical instruments, drives the market growth. Also, the advances in PCR, such as improvements in system design and advanced assay development, provide high accuracy and efficiency in tissue typing. The advancement in transplant technology increases patient safety and monitors organ functioning. This ultimately increases the post-transplant recovery period. The growing acquisition of small hospitals has helped to increase organ transplantation, wound care, and transplant diagnosis in the market, which has indirectly impacted the growth of HLA typing transplant market positively. Tier 1 hospitals acquire small specialized hospitals, which helps to train the healthcare staff, physicians, and nurses. It also helps to meet growing patient needs by providing a range of patient monitoring equipment. “The presence of skilled professionals in these hospitals encourages people to opt for these smaller specialty hospitals. The skills and techniques used by professional healthcare providers have improved with the increasing number of M&As. It helped the global HLA typing transplant market to grow,” says Srinivas. Become a Technavio Insights member and access all three of these reports for a fraction of their original cost. As a Technavio Insights member, you will have immediate access to new reports as they’re published in addition to all 6,000+ existing reports covering segments like oncology, vaccines, and urology devices. This subscription nets you thousands in savings, while staying connected to Technavio’s constant transforming research library, helping you make informed business decisions more efficiently. Technavio is a leading global technology research and advisory company. The company develops over 2000 pieces of research every year, covering more than 500 technologies across 80 countries. Technavio has about 300 analysts globally who specialize in customized consulting and business research assignments across the latest leading edge technologies. Technavio analysts employ primary as well as secondary research techniques to ascertain the size and vendor landscape in a range of markets. Analysts obtain information using a combination of bottom-up and top-down approaches, besides using in-house market modeling tools and proprietary databases. They corroborate this data with the data obtained from various market participants and stakeholders across the value chain, including vendors, service providers, distributors, re-sellers, and end-users. If you are interested in more information, please contact our media team at media@technavio.com.


DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Global HLA Typing Transplant Market 2017-2021" report to their offering. The global HLA typing transplant market to grow at a CAGR of 9.20% during the period 2017-2021. The report, Global HLA Typing Transplant Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market. One trend in the market is new government initiatives for HLA typing. The growing concerns about hepatitis and HIV are leading the government to develop few standards and strategies to reduce the number of communicable diseases through transplantation. Quality measurement in government-introduced programs lead to increased adoption of bone marrow and umbilical cord transplantation. According to the report, one driver in the market is growing incidence of organ failure. The demand for tissue and organs such as bone marrow, heart, liver, kidney, and lungs is very high worldwide. The increasing rate of alcohol consumption, unhealthy lifestyles and food habits, and drug intake are the leading causes of organ failure. In addition, the rise in older adult population results in increased demand for organs for transplantation. According to a combined study conducted by the Department of Internal Medicine, Division of Hepatology, Loyola University Medical Center; Department of Preventive Health Sciences, Stritch School of Medicine, Loyola University Chicago; and Division of Gastroenterology and Hepatology, University of Michigan Health System, in 2015, liver cirrhosis is one of the major factors of death in the US. For more information about this report visit http://www.researchandmarkets.com/research/3rgnwf/global_hla_typing


News Article | May 8, 2017
Site: www.businesswire.com

CAMBRIDGE, Mass.--(BUSINESS WIRE)--ImmusanT, Inc., a clinical-stage company developing Nexvax2®, a therapeutic vaccine intended to protect against the effects of gluten exposure while maintaining a gluten-free diet in HLA-DQ2.5+ patients with celiac disease, today announced the presentation of data demonstrating a novel method of identifying patients on a gluten-free diet with celiac disease. The study, conducted in collaboration with researchers from the Walter and Eliza Hall Institute, was presented in an oral presentation at Digestive Disease Week (DDW) 2017 in Chicago, Illinois. Celiac disease (CeD) is an immune-mediated gastrointestinal disease caused by dietary gluten predominantly in individuals who carry the human leukocyte antigen-DQ2.5 (HLA-DQ2.5) immune recognition gene, and shares key pathogenic and genetic features with organ-specific autoimmune diseases. Currently, there is no pharmaceutical treatment for celiac disease and the only method of management is to maintain a gluten-free diet (GFD). GFD is often adopted before evaluation for CeD, which renders current tests for CeD inaccurate and creates diagnostic and management uncertainty. Patients on a GFD who seek a diagnosis of CeD often refuse or cannot tolerate a gluten challenge for the duration typically needed for accurate results of tests for serological and histological markers of CeD. Because of this, a faster and more tolerable diagnostic is needed to identify patients on a gluten-free diet with celiac disease. “In this study, we have identified a distinct cytokine signature present in the serum of subjects with celiac disease 4 hours after the ingestion of gluten, suggesting that the measurement of serum cytokines following a single gluten challenge may allow for the identification of patients on a gluten-free diet with celiac disease,” said Dr. Bob Anderson, Chief Scientific Officer of ImmusanT. “We are hopeful that with additional studies, this could ultimately provide an improved alternative to current methods of testing for the diagnosis of celiac disease, which are cumbersome and often not well tolerated by the patient.” “Celiac disease is estimated to affect approximately 1% of the United States population, but over 80% of cases remain undiagnosed, as methods of diagnosis are invasive and inconvenient for patients,” said Leslie Williams, President and Chief Executive Officer of ImmusanT. “The study presented today provides rationale for continued development of this novel diagnostic method as we aim to provide a more sensitive, rapid and tolerable alternative to current tests for patients suffering from celiac disease.” In an oral presentation titled “Serum IL-2 and IL-8 are elevated within 4h after gluten ingestion in celiac disease (CeD) patients on glutenfree diet (GFD) – potential to resolve indeterminate diagnoses for patients on GFD,” Dr. Anderson presented data from a randomized, double-blind, placebo-controlled food challenge study that enrolled volunteers with HLA-DQ2.5+ celiac disease who were compliant with a gluten-free diet. In the study, 21 volunteers received either vital wheat gluten flour or a matched gluten-free flour drink over the course of 10 minutes. Serum chemokines and cytokines were measured 30 minutes prior to food challenge, then at four, six, and 24 hours after the challenge. Vital signs and patient-reported outcomes (CeD PRO) were recorded hourly. Results of the study demonstrated that, at 4 hours following food challenge, serum levels of the cytokine IL-8 were significantly higher after exposure to gluten than placebo (median fold change from baseline: gluten: 2.4 vs. placebo: 1.1, p=0.012). Serum levels of IL-2 were also significantly increased at 4 hours, confirming T-cell activation in response to gluten exposure (median fold change from baseline: gluten: 19.5 vs. placebo: 0.7, p=0.0001). Celiac disease is a T cell-mediated autoimmune disease triggered by the ingestion of gluten from wheat, rye and barley in genetically susceptible individuals. A gluten-free diet is the only current management for this disease. The community prevalence of celiac disease is approximately 1% in the U.S., but over 80% of cases go unrecognized. When a person with celiac disease consumes gluten, the individual’s immune system responds by triggering T cells to fight the offending proteins, damaging the small intestine and inhibiting the absorption of important nutrients into the body. Undiagnosed, celiac disease is a major contributor to poor educational performance and failure to thrive in children. Untreated disease in adults is associated with osteoporosis and increased risk of fractures, anemia, reduced fertility, problems during pregnancy and birth, short stature, dental enamel hypoplasia, dermatitis, recurrent stomatitis and cancer. With no available drug therapy, the only option is a strict and lifelong elimination of gluten from the diet. Compliance is often challenging, and the majority of people continue to have residual damage to their small intestine in spite of adherence to a gluten free diet. Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 6-9, 2017, at McCormick Place, Chicago, IL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org. ImmusanT is a privately held biotechnology company focused on protecting patients with celiac disease against the effects of gluten. By harnessing new discoveries in immunology, ImmusanT aims to improve diagnosis and medical management of celiac disease by protecting against the effects of gluten exposure while patients maintain a gluten-free diet. The company is developing Nexvax2®, a therapeutic vaccine for celiac disease, and diagnostic and monitoring tools to improve celiac disease management. ImmusanT’s targeted immunotherapy discovery platform can be applied to a variety of autoimmune diseases. Founded in 2010, ImmusanT is backed by Vatera Healthcare Partners. More information may be found at www.ImmusanT.com, or follow ImmusanT on Twitter.


The global HLA typing transplant market to grow at a CAGR of 9.20% during the period 2017-2021. The report, Global HLA Typing Transplant Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market. One trend in the market is new government initiatives for HLA typing. The growing concerns about hepatitis and HIV are leading the government to develop few standards and strategies to reduce the number of communicable diseases through transplantation. Quality measurement in government-introduced programs lead to increased adoption of bone marrow and umbilical cord transplantation. According to the report, one driver in the market is growing incidence of organ failure. The demand for tissue and organs such as bone marrow, heart, liver, kidney, and lungs is very high worldwide. The increasing rate of alcohol consumption, unhealthy lifestyles and food habits, and drug intake are the leading causes of organ failure. In addition, the rise in older adult population results in increased demand for organs for transplantation. According to a combined study conducted by the Department of Internal Medicine, Division of Hepatology, Loyola University Medical Center; Department of Preventive Health Sciences, Stritch School of Medicine, Loyola University Chicago; and Division of Gastroenterology and Hepatology, University of Michigan Health System, in 2015, liver cirrhosis is one of the major factors of death in the US. PART 01: Executive summary PART 02: Scope of the report PART 03: Research Methodology PART 04: Introduction PART 05: Market landscape PART 06: Market segmentation by products PART 07: Market segmentation by technology PART 08: Market segmentation by end-user PART 09: Geographical segmentation PART 10: Decision framework PART 11: Drivers and challenges PART 12: Market trends PART 13: Vendor landscape PART 14: Key vendor analysis PART 15: Appendix For more information about this report visit http://www.researchandmarkets.com/research/4zmjxq/global_hla_typing To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-hla-typing-transplant-market-to-grow-at-a-cagr-of-92-by-2021-growth-driven-by-new-government-initiatives-for-hla-typing---research-and-markets-300451293.html


DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Blood Group Typing Market - Global Forecast to 2021" report to their offering. The blood group typing market is projected to reach USD 3.12 billion by 2021 from USD 1.95 billion in 2016, at a CAGR of 9.8%. Growth in the blood group typing market is primarily attributed to the increasing demand for blood and blood products, growing number of road accidents and trauma cases that necessitate blood transfusion, need for blood grouping during prenatal testing, and increasing usage of blood group typing in forensic sciences. Stringent regulatory standards for blood transfusion are also expected to fuel the growth of the blood group typing market during the forecast period. Based on product and service, the market is segmented into consumables, instruments, and services. The consumables segment is further categorized into antisera reagents, anti-human globulin reagents, red blood cells reagents, and blood bank saline. The consumables segment is expected to grow at the highest CAGR during the forecast period. The increase in blood donation rates and major surgical procedures (including organ transplant procedures) are the key factors driving the growth of this segment. Based on test type, the market is segmented into antibody screening, HLA typing, cross-matching tests, ABO blood tests, and antigen typing. The antibody screening segment is expected to grow at the highest CAGR during the forecast period. The growth of this market segment is primarily driven by the increasing prevalence of chronic disorders and growing demand for the early diagnosis of diseases. For more information about this report visit http://www.researchandmarkets.com/research/l25zhx/blood_group


News Article | April 27, 2017
Site: globenewswire.com

                   Paris, France - 27 avril 2017 - Le Directoire de Diaxonhit (Alternext : ALEHT, FR0004054427), groupe français leader sur le marché du diagnostic in vitro de spécialités dans les domaines de la transplantation, des maladies infectieuses et de l'oncologie, s'est réuni le 26 avril 2017 et a arrêté les comptes consolidés au 31 décembre 2016. Ces comptes ont été vérifiés par le Conseil de Surveillance2. La transition engagée dès l'été 2016 a entrainé un certain nombre de charges financières et exceptionnelles qui sont notamment liées au plan de réorientation et au plan de réduction de la dilution mis en oeuvre, pour un montant global d'environ 1 M€. Ces facteurs expliquent le résultat net en retrait à -7,9 M€, incluant tous les amortissements liés à l'acquisition d'Ingen, et à -9,6 M€ pro forma, incluant tous les frais financiers et amortissements liés aux acquisitions d'Ingen et de Capforce Plus. Les ventes annuelles de produits de diagnostic in vitro s'inscrivent dans la fourchette annoncée en janvier 2017. Elles s'élèvent ainsi à 27,6 M€ contre 28,9 M€ en 2015, et reflètent le retard dans la disponibilité des nouveaux tests NGS pour le typage HLA et le ralentissement des commandes de tests transplantation à cause des contraintes budgétaires des laboratoires hospitaliers, partiellement compensés par la bonne progression des autres secteurs du diagnostic et du contrôle qualité. Par ailleurs, les produits de R&D thérapeutique se sont élevés à 0,1 M€, en diminution par rapport à 2015 où la Société avait reçu un paiement d'étape non-récurrent d'Allergan de 0,4 M€. Sur une base pro forma, intégrant les résultats 2016 de la société Capforce Plus et de ses filiales comme si elles avaient été acquises le 1er janvier 2016, le chiffre d'affaires annuel s'élève à 44,1 M€, et le montant des revenus annuels à 45 M€. La réduction du coût d'achat des marchandises est directement liée à la baisse des ventes de produits de diagnostic in vitro. Toutefois ce coût d'achat reste affecté par la poursuite du renchérissement du dollar US. Compte-tenu des caractéristiques des contrats d'achat à terme de dollars US détenus par Diaxonhit, le taux de change moyen des dollars achetés en 2016 s'est établi à 1,1463 dollars US par euro contre 1,2173 en 2015. A taux de change constant entre 2015 et 2016, le coût d'achat des marchandises aurait ainsi été inférieur d'environ 0,9 M€. Il est rappelé que les actifs commerciaux réévalués consécutivement à l'acquisition d'IBS font l'objet d'un amortissement sur 10 ans, soit 1 286 K€ au 31 décembre 2016. Ils sont inclus dans les frais marketing et commerciaux. De même, depuis le début de la commercialisation de BJI Inoplex, un actif R&D relatif à ce test et également réévalué consécutivement à l'acquisition d'IBS, fait l'objet d'un amortissement sur 10 ans, soit 98 K€ au 31 décembre 2016, inclus dans les frais de R&D. L'écart d'acquisition restant fait aussi l'objet d'un amortissement sur 10 ans qui vient en déduction du résultat opérationnel et représente, au 31 décembre 2016, une charge de 308 K€. L'ensemble de ces amortissements représente une charge sans effet sur la trésorerie de la Société. Au 31 décembre 2015, Diaxonhit disposait d'une trésorerie de 11,7 M€. Compte-tenu de financements reçus de 0,5 M€ nets des charges d'intérêts et remboursements intervenus sur les obligations, les emprunts et les avances remboursables de la Société, et d'une consommation de trésorerie opérationnelle de 3,3 M€, la trésorerie du Groupe s'élève à 7,9 M€ au 31 décembre 2016. Diaxonhit détient la licence exclusive du test AlloMap® pour l'Europe. En janvier 2016, Diaxonhit et CareDx Inc. ont finalisé avec succès le transfert du test d'expression génomique AlloMap pour la surveillance régulière et non invasive du rejet cellulaire aigu chez les greffés cardiaques, au Laboratoire Central d'Immunologie des Hôpitaux Universitaires de Strasbourg (HUS) en France. Ce transfert a été réalisé en plusieurs étapes qui ont démontré que les résultats des tests AlloMap effectués par le laboratoire des HUS sont les mêmes que ceux qui ont été obtenus par le laboratoire principal de CareDx aux États-Unis. C'est une étape importante pour Diaxonhit et CareDx, tout en étant le premier transfert de ce type pour un test moléculaire développé et déjà commercialisé aux USA. En mai 2016, Diaxonhit et les HUS ont inauguré le centre de traitement des tests AlloMap. Ce centre répond à toutes les exigences de qualité nécessaires pour assurer la précision et la reproductibilité des résultats rendus aux prescripteurs. La Société lui fournit les éléments du test produits par CareDx et lui met également à disposition les instruments nécessaires à la réalisation du test. Diaxonhit fournit aussi aux centres de transplantation cardiaque européens un kit pour réaliser la préparation des échantillons de sang et leur expédition. Dans le cadre de cette étude, dont les résultats sont attendus au cours de l'année 2017, 1 700 prélèvements à l'aiguille fine ont été effectués sur des nodules thyroïdiens découverts chez les 1 581 patients recrutés dans 17 centres cliniques européens (10 en France, 4 en Italie et 3 en Espagne) spécialisés dans le diagnostic et le suivi du cancer de la thyroïde. Avec ces caractéristiques, l'étude CITHY est la plus grosse étude de ce type et une première en Europe qui va également permettre de mieux caractériser les pratiques européennes de suivi des patients présentant un ou plusieurs nodules de la thyroïde. Une nouvelle étude prospective en vie réelle a été réalisée à l'hôpital Raymond-Poincaré (AP-HP) de Garches et à l'hôpital Joseph-Ducuing de Toulouse. Elle a porté sur l'utilisation en routine de BJI InoPlex, avec 361 tests réalisés sur 314 patients plus représentatifs de la population ciblée dans les centres de deuxième ligne. Pour les 80 patients avec une infection chronique à staphylocoque, la performance de BJI InoPlex est améliorée par rapport à celle observée dans l'étude de validation du test. Par ailleurs, les résultats du test BJI InoPlex et de la mise en culture de ponctions articulaires réalisées avant chirurgie, qui avaient été obtenus dans le cadre de l'étude initiale de validation, ont fait l'objet d'une analyse complémentaire en excluant les 72 patients pour lesquels aucune ponction n'avait été réalisée ou pour lesquels le résultat de BJI InoPlex était indéterminé. Cette nouvelle analyse montre d'une part que les résultats de culture sur ponctions articulaires réalisées avant intervention chirurgicale ne sont pas aussi fiables qu'il est généralement admis. Ils montrent aussi clairement que cette fiabilité peut être améliorée en combinant la microbiologie classique à BJI InoPlex. Pendant l'année 2016, DIAXONHIT collaborait avec la société de biotechnologie InnaVirVax dans le cadre d'un consortium ayant pour objectif la mise au point de VAC-3S, un vaccin thérapeutique pour traiter les malades atteints du Sida, et le développement d'un test diagnostique compagnon du vaccin, dont le prototype avait été finalisé en cours d'année.                   InnaVirVax vient d'annoncer à la Société que les résultats de sa dernière étude clinique étaient médiocres. Sur cette base, InnaVirVax a pris la décision d'interrompre définitivement le développement de VAC-3S, et en a notifié Bpifrance et les membres du consortium Prothevih. En conséquence, le développement du test compagnon de VAC-3S est également arrêté par Diaxonhit. La Société évalue actuellement les conséquences de cet arrêt, et en particulier l'utilité de poursuivre le développement du test indépendamment du vaccin thérapeutique.                     Afin de réduire la dilution future des actionnaires de Diaxonhit, quatre transactions spécifiques ont été réalisées en deux temps.                   Au cours de l'exercice 2016, la société a réalisé tout d'abord des amortissements en numéraire d'obligations convertibles émises en juin 2014 (OCA), pour un total de 383 K€. D'autre-part, elle a procédé au rachat en numéraire de 6.158.000 bons de souscription qui avaient également été émis en juin 2014 (BSA), pour 537 K€. Ce dernier montant a constitué une charge financière exceptionnelle sur l'exercice 2016.                   Depuis le 1er janvier 2017, et notamment dans le cadre de la finalisation de l'acquisition de Capforce Plus, Diaxonhit a procédé à deux nouveaux amortissements en numéraire d'OCA pour un montant total de 525 K€, puis racheté 5.953.470 BSA.  Cette restructuration globale a entrainé l'émission de 3.453.012 actions nouvelles.                   Sur la base d'un amortissement par émission d'actions au cours de 0,22€ par actions, les amortissements effectués en numéraire en 2016 et depuis le début de l'année 2017, se seraient traduits par l'émission de 4.127.093 actions supplémentaires. Cumulé aux transactions effectuées sur les BSA, c'est un total de 12.785.551 actions qui ne seront plus émises, soit environ 7% du capital actuel.                     Fort de ses 120 collaborateurs, le nouveau groupe Diaxonhit, acteur intégré français du diagnostic in vitro, intervient de la recherche à la commercialisation de produits diagnostiques de spécialités et désormais également de produits pour la recherche dans le domaine des sciences de la vie. D'autre-part, son expansion continue à s'appuyer à la fois sur la croissance de ses activités commerciales de distribution et sur le développement de produits propriétaires et innovants à forte valeur ajoutée.         Diaxonhit possède un portefeuille étendu et diversifié de produits propriétaires dans quatre spécialités : la transplantation, les maladies infectieuses, les sciences du vivant et le cancer.                   Dans le domaine de la transplantation, le groupe commercialise des milieux de transport et de préservation des greffons de cornée ainsi qu'un dispositif breveté, Iglide(TM), pour en faciliter la mise en oeuvre chirurgicale. Il commercialise également Allomap, un test moléculaire pour le suivi des transplantés cardiaques, dont il détient la licence exclusive pour l'Europe.                   Dans le domaine des maladies infectieuses, le groupe commercialise plusieurs produits propriétaires et notamment TQS pour l'identification du statut immunitaire vis-à-vis du tétanos, BJI Inoplex pour le diagnostic des infections ostéo-articulaires sur prothèse, ainsi que la gamme de biologie moléculaire Eurobioplex (EBX) qui comprend un ensemble de tests permettant d'identifier de nombreux agents pathogènes et d'en évaluer la quantité présente dans l'organisme des patients infectés.                   Dans le domaine des sciences de la vie, le groupe développe un ensemble de produits destinés à la R&D, en particulier auprès d'organismes publics de recherche et de l'industrie pharmaceutique. Il commercialise notamment des milieux de culture cellulaires, des réactifs de biologie moléculaire ainsi que des anticorps propriétaires. Doté d'un laboratoire et d'une forte expertise industrielle, le groupe propose un service de production à façon dédié aux sociétés de biotechnologie ou pharmaceutiques.                   Par ailleurs, Diaxonhit développe d'autres produits sur la base de sa plateforme de biologie moléculaire, en particulier Dx15 pour le diagnostic du cancer de la thyroïde. A travers ses filiales commerciales, Eurobio et Ingen, le groupe renforce aujourd'hui sa position de 1er distributeur indépendant français de diagnostics in vitro sur son territoire.                   Dans ce cadre, il commercialise des tests de diagnostic de spécialité auprès des laboratoires d'analyses de biologie médicale hospitaliers et privés. Il est ainsi le leader en France du marché des tests HLA pour la transplantation. Il commercialise également en exclusivité des tests et des solutions automatisées issus de partenaires industriels étrangers (américains, coréens, européens.) dans les domaines des maladies infectieuses, de l'auto-immunité et des contrôles qualité. Il propose aussi toute une gamme de réactifs et d'instruments dédiés aux laboratoires des sciences de la vie.                   S'appuyant sur ses ingénieurs et spécialistes produits, le groupe assure également un service client haut-de-gamme, avec assistance téléphonique, support technique et service après-vente pour une importante base de plus de 400 instruments installés dans les laboratoires de ses clients. Diaxonhit (Alternext, FR0004054427, ALEHT) est un acteur majeur dans le domaine du diagnostic in vitro de spécialités et des sciences de la vie. Il intervient de la recherche à la commercialisation de tests diagnostiques dans les domaines de la transplantation, des maladies infectieuses et de l'oncologie, ainsi que de produits pour la recherche dans le domaine des sciences du vivant. Il est notamment le leader en France de la commercialisation des tests HLA. Avec ses nombreux partenariats et sa forte présence hospitalière, Diaxonhit dispose de son propre réseau étendu de distribution et d'un portefeuille de produits propriétaires parmi lesquels Tétanos Quick Stick®, BJI Inoplex®, et la gamme de biologie moléculaire EBX (Dengue, Chickungunya, Zika, Hépatite delta, etc.) dans le domaine des maladies infectieuses. Dans le domaine des sciences de la vie, le groupe développe un ensemble de produits destinés à la R&D, en particulier auprès d'organismes publics de recherche et de l'industrie pharmaceutique. Il commercialise notamment des milieux de culture cellulaires, des réactifs de biologie moléculaire ainsi que des anticorps propriétaires, et propose un service de production à façon dédié aux sociétés de biotechnologie ou pharmaceutiques. Diaxonhit produit et commercialise également des milieux de transport et de préservation des greffons de cornée ainsi qu'un dispositif breveté, Iglide(TM), pour en faciliter la mise en oeuvre chirurgicale. La Société est membre du GIE européen DiaMondial. Ce communiqué comporte des éléments non factuels, notamment et de façon non exclusive, certaines affirmations concernant des résultats à venir et d'autres événements futurs. Ces affirmations sont fondées sur la vision actuelle et les hypothèses de la Direction de la Société. Elles incorporent des risques et des incertitudes connues et inconnues qui pourraient se traduire par des différences significatives au titre des résultats, de la rentabilité et des événements prévus. En outre, Diaxonhit, ses actionnaires et ses affiliés, administrateurs, dirigeants, conseils et salariés respectifs n'ont pas vérifié l'exactitude des, et ne font aucune déclaration ou garantie sur, les informations statistiques ou les informations prévisionnelles contenues dans le présent communiqué qui proviennent ou sont dérivées de sources tierces ou de publications de l'industrie; ces données statistiques et informations prévisionnelles ne sont utilisées dans ce communiqué qu'à des fins d'information. Enfin, le présent communiqué peut être rédigé en langue française et en langue anglaise. En cas de différences entre les deux textes, la version française prévaudra.

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