September 29, 2016 | News from MDxHealth, Xcell Biosciences, Canon, and more.
Roche announced that the Harmony Prenatal Test for assessing the probability of Down syndrome (Trisomy 21) and other chromosomal disorders has received the CE mark. This enables laboratories to perform local in vitro diagnostic (IVD) testing in countries that accept the mandatory conformity marking. Local testing availability permits laboratories to comply with reimbursement requirements and expedite test results for healthcare providers and expectant parents in their regions. Press release.
MDxHealth announced that it has signed a distribution agreement with The European Health Centre Innovation (EHC Innovation) to offer its SelectMDx(TM) for Prostate Cancer and ConfirmMDx(R) for Prostate Cancer tests to their urology customers throughout Poland. Under the terms of the agreement, EHC Innovation will be one of two exclusive distributors of SelectMDx in Poland and the only exclusive distributor of ConfirmMDx. Samples will be sent to MDxHealth's state-of-the-art clinical diagnostic laboratory in Nijmegen, The Netherlands for analysis. EHC Innovation will reimburse MDxHealth for all testing services. Press release.
HudsonAlpha Institute for Biotechnology announced that it will extend its unique breast and ovarian cancer genetic risk testing initiative Information is Power for a second year. The announcement was made at HudsonAlpha’s annual Tie the Ribbons luncheon to support breast and ovarian cancer research. The initiative was set to wrap up in October of this year, but because of a sponsorship from Redstone Federal Credit Union, the initiative will be extended and expanded. Press release.
Xcell Biosciences announced today that it has extended its collaborative work with the University of California, San Francisco (UCSF) to include working with three principal investigators on pilot studies using Xcell’s Avatar cell culture system and proprietary analytics platform. The work will determine if large scale RNA profiling from peripheral blood and other patient-derived sample sources cultured in the Avatar System and correlated to clinical outcomes can predict a patient’s response to first or second line treatments in prostate, bladder and kidney cancers. Press release.
Canon U.S.A. announced that it has made an equity investment in T2 Biosystems, a company developing innovative diagnostic products to improve patient health. Through this investment, Canon U.S.A. has purchased approximately $40 million of the company's stock at the closing market price of $6.56 in a private placement, resulting in Canon's ownership of approximately 19.9% of T2 Biosystems. Canon U.S. Life Sciences, a wholly owned subsidiary of Canon U.S.A., began working with T2 Biosystems back in February of 2015 to develop a diagnostic test panel for rapidly detecting Lyme disease. Press release.
The American Society of Human Genetics (ASHG) has chosen Bruce R. Korf, MD, PhD, as the incoming Editor-in-Chief of The American Journal of Human Genetics (AJHG), published by Cell Press. Dr. Korf’s term will begin in January 2018. The current Editor-in-Chief, David L. Nelson, PhD, will end his tenure in December 2017. Dr. Korf is a medical geneticist, educator, and child neurologist, with research interests in the molecular diagnosis of genetic disorders and the natural history, genetics, and treatment of neurofibromatosis. He currently serves as Wayne H. and Sara Crews Finley Chair in Medical Genetics, Professor and Chair of the Department of Genetics, and Director of the Heflin Center for Genomic Sciences at the University of Alabama, Birmingham (UAB). He also co-directs the UAB-HudsonAlpha Center for Genomic Medicine. A member of ASHG since 1983, Dr. Korf served on the Society’s Board of Directors from 2004-2005 and received its annual Award for Excellence in Human Genetics Education in 2009. He was a member of the AJHG Editorial Board from 2003-2005, and has served on numerous institutional, regional, and national committees over the years. He has published nearly 200 articles in the scientific literature. Press release.
DNAnexus announced that M2Gen has adopted the company’s cloud translational science platform to support molecular data access, management, collaboration, and analysis for the Oncology Research Information Exchange Network (ORIEN) Avatar Research Program. This initiative unites academic cancer centers and pharmaceutical companies in pursuit of shared translational oncology goals: the development of more precise cancer treatments for patients. Press release.
GenomeDx Biosciences announced the publication of the first prospective validation study for its Decipher Prostate Cancer Classifier test, Decipher Post-Op, a genomic test used to improve clinical decision-making following radical prostatectomy. In the study, Decipher Post-Op reclassified tumor aggressiveness in a large number of patients based on genomic risk assessment, as compared to traditional clinical and pathological risk assessment. These reclassifications have the potential to alter postoperative therapy decisions for patients following prostatectomy by predicting if an individual is at low, intermediate or high risk of tumor metastasis. The study, titled "Decipher correlation patterns post-prostatectomy: initial experience from 2342 prospective patients," was published this month ahead of print in Prostate Cancer and Prostatic Diseases. Press release.