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This Week In Diagnostics

Trinity Biotech acquires Fiomi Diagnostics Trinity Biotech plc (Nasdaq: TRIB), a developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, says that it has acquired Fiomi Diagnostics AB (Uppsala, Sweden) for $13.1M consisting of a cash payment of $5.6M, 408,000 Trinity Biotech ADRs at the acquisition date ($4.1M) and a contingent cash consideration of $3.4M.  The Swedish company has reported that it is in the late stages of developing a panel of point-of-care cardiac marker assays based on technology that was originally developed by Amic AB. To date, Fiomi's efforts have focused on developing a cardiac test for Troponin I.   Critical Diagnostics reports results of biomarker panel study Critical Diagnostics, a biomarker company focused on cardiovascular diseases, has reported positive results from a multi-center study in ambulatory heart failure patients, which confirmed that a contemporary panel of biomarkers was strongly predictive of risk and significantly improved the likelihood of identifying patients at risk for adverse events, compared to the most commonly used clinical risk score in heart failure, the Seattle Heart Failure Model (SHFM). The Penn Heart Failure Study was a multi-center cohort of 1,513 outpatients with chronic heart failure, used a panel of seven biomarkers, including ST2 as measured using the Presage ST2 Assay, and compared results to SHFM. Patients in the highest one-third of the multi-marker score had a 13.7-fold increased risk of adverse outcomes compared to the lowest one-third, and this risk remained nearly 7-fold higher after adjustment for the SHFM. Moreover, the PHFS panel appropriately reclassified a quarter of the patients into a higher risk category.   Transgenomic validates its Clopidogrel (Plavix®) Response Panel Transgenomic Inc. (OTCBB: TBIO) has provided news about the publication of a new study by researchers at Vanderbilt University that further validates the role of both genes found in the company’s PGxPredict®:CLOPIDOGREL (Plavix®) Panel, a comprehensive test to predict a patient’s response to clopidogrel (Plavix®). The study confirms the results of two previous studies demonstrating that outcomes in patients receiving clopidogrel were better for patients without genetic variations in CYP2C19, a gene whose effect is described in the drug’s label, and ABCB1, a gene that is unique to Transgenomic’s panel. The results were published by Delaney, et al., in the February issue of Clinical Pharmacology and Therapeutics.   Courtagen to Partner with Avaxia Biologic Courtagen Life Sciences says that it has entered into a strategic collaboration with Avaxia Biologics to develop an assay that will streamline the development of an oral antibody therapy to mitigate the gastrointestinal damage that follows radiation exposure that might occur after a nuclear incident. Together the two companies will pursue a first in class solution that could enable the Biomedical Advanced Research and Development Authority (BARDA) and other Federal biodefense programs to achieve their goal of developing therapeutics to mitigate the damage to the gastrointestinal tract that follows severe whole body exposure to ionizing radiation.   Molecular disease model for lung cancer developed Cancer Commons, an open‐science initiative to personalize cancer treatments and accelerate research, have published a molecular disease model (MDM) for lung cancer. The paper, by Lisandra West, Ravi Salgia, was published in the February 21 issue of PLoS ONE (http://www.plosone.org). The purpose of this paper, the authors say, is to highlight the key molecular aberrations observed in lung cancer, including those for which there is still only preclinical data, with the hope of accelerating the process of translational research by providing a dynamic conduit between basic science researchers, clinical trialists, and treating physicians. The lung cancer MDM classifies the disease into subtypes based on a tumor’s histology and its molecular profile. Each subtype is then linked to published clinical treatment guidelines and other proposed therapy options, including investigational agents available through clinical tests. This information can help physicians understand therapy options for individual patients based on their tumor’s molecular subtype. Going forward, the resulting clinical responses can be used to refine the model. The MDM is a living review article, maintained by experts and continually updated based on input from the entire cancer community. “CollabRx is very excited to have been a collaborator on this important open science initiative. Using technology to make the best science readily accessible to patients and their physicians in the rapidly emerging field of personalized medicine is the very reason we were founded,” said James Karis, CEO of CollabRx, a cancer informatics company that collaborated on the development of the MDM.   Complete Genomics creates Advisory Board Complete Genomics Inc. (Nasdaq: GNOM) says that it has formed a Genomic Medicine Advisory Board (GMAB) that will provide insight and guidance on the best ways for the company to provide sequencing services to healthcare organizations and physicians interested in implementing genomic medicine in their practice. Robert Nussbaum, MD, Holly Smith Professor of Medicine, chief of the Division of Medical Genetics in the Department of Medicine, and director of the Cancer Risk and Cardiovascular Genetics Programs at the University of California, San Francisco, will serve as GMAB chairman.   CombiMatrix appoints board members Richard Ding, CEO of bioTheranostics Inc. and Joseph M. Limber, President and CEO of Prometheus Laboratories have been appointed to the Board of Directors of CombiMatrix. The addition of the new directors brings the total number of board members to nine.   BioNJ Diagnostics & Personalized Medicine Innovation Summit BioNJ, the trade association for New Jersey's biotechnology industry, is hosting its BioNJ Diagnostics & Personalized Medicine Innovation Summit and Funding Roundtable, part of BioNJ's ongoing Diagnostics & Personalized Medicine Initiative, on March 14, 2012 at Princeton University. The event is designed to bring together leaders from major global biotechnology and pharmaceutical companies, diagnostics companies and emerging "innovator" companies for this half-day, interactive summit meeting. The focus of this half-day summit is to help participants identify opportunities for partnership, funding and growth while updating them on the latest trends, developments and challenges in the evolution and adoption of personalized medicine. All companies and individuals with an interest in diagnostics and personalized medicine are welcome to attend this event. The Summit will include company presentations and opportunities for one-on-one communication and interaction between leading global pharmaceutical companies, emerging diagnostics companies, funding organizations and life sciences company business development professionals. Details: www.bionj.org -Peter Winter

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