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News and Notes in Diagnostics October 2016

October 28, 2016 | News from Cirina, Illumina, HudsonAlpha, and more. 

MDxHealth SA announced that Health Care Services Corporation (HCSC) has issued coverage for patients meeting the eligibility criteria established under the positive medical policy on the ConfirmMDx(R) for Prostate Cancer test. HCSC is the largest customer-owned health insurer in the United States and fourth largest overall, operating through HCSC's Blue Cross and Blue Shield(R) Plans in Illinois, Montana, New Mexico, Oklahoma and Texas. The company, founded in 1936, serves more than 15 million members across five states and employs more than 22,000 people in over 60 local offices. Press release

Emulate announced that its human Lung-Chip system has expanded functionality to now also model conditions in which inhaled toxins enter the lung, including cigarette smoke, e-cigarettes constituents, and potentially environmental airborne contaminants. The new applications are based on results published online in Cell Systems led by the Wyss Institute for Biologically Inspired Engineering at Harvard University. Emulate has exclusively licensed the technology used in the study from the Wyss Institute at Harvard University for translation into commercial products, including the company’s “Human Emulation System.” Press release

Cirina named Maneesh Jain, PhD, its CEO, and announced the completion of Series A financing, and the expansion of its headquarters. The company was co-founded in 2014 by the plasma nucleic acid scientist, Dennis Lo. Lo was the first scientist to discover the presence of fetal DNA in a pregnant mother’s blood-plasma. He has been recognized with several prestigious awards for his numerous discoveries and lifetime of contributions to the field. He was recently named a 2016 Thomson Reuters Citation Laureate in recognition of the high citations of his research work that rank him in the top 0.1 percent of his field worldwide. He also received the 2016 Future Science Prize in Life Science for all of his contributions to the field of noninvasive blood-based diagnoses. Cirina is applying his life-long work and utilizing his expertise to develop products that will enable clinicians to confidently diagnose various forms of cancer and other deadly diseases at their earliest stages, empowering people to take action when curative treatment is still viable. Press release

Illumina and Laboratory Corporation of America Holdings announced that on October 5, 2016, the Düsseldorf Regional Federal Court in Germany issued a preliminary injunction order against amedes MVZ Trägergesellschaft Göttingen mbH and a related company (collectively “amedes”). The order requires amedes to immediately stop performing the Fetalis non-invasive prenatal screening test in Germany, which is based on technology from Ariosa Diagnostics. The Application for the Grant of a Preliminary Injunction against amedes was filed by Sequenom, a wholly-owned subsidiary of LabCorp, as patent owner of EP 0 994 963. The patent relates to the detection of cell-free fetal DNA for non-invasive prenatal screening. Illumina exclusively licenses the patent in the field of in vitro diagnostics. Illumina and Sequenom have significant intellectual property rights in the area of non-invasive prenatal screening and will continue to enforce those rights when appropriate. This suit adds to prior patent infringement suits filed against others in Europe, Australia and the United States. Press release

Golden Helix announced the availability of Copy Number Variation (CNV) analysis in its VarSeq software. The CNV capability is part of the VarSeq clinical reports package.

The VarSeq Clinical Suite offers streamlined and integrated analysis, taking a sample from a VCF formatted file to a clinical report seamlessly. VarSeq’s automated workflows allow labs to automate the process in order to create a high-throughput environment. Further, VSWarehouse provides centralized storage of all genomic data, providing the additional capability to search for variants, easily engineer complex queries, and connect to other lab and hospital level applications.

Good Start Genetics announced reduced and simplified pricing to further expand access to EmbryVu, the company's proprietary, preimplantation genetic screening (PGS) test. PGS is a physician-ordered test used to identify embryos with the correct number of chromosomes prior to implantation to help improve pregnancy rates. The new price for the test is $150 per embryo in all cases, decreasing further to $100 per embryo after the eighth embryo tested. Press release

ClearLight Diagnostics announced that it has signed a collaboration agreement with the Oregon Health & Science University Center for Spatial Systems Biomedicine (OCSSB) to study the tumor microenvironment in patients with cancer. Working with researchers at OCSSB, ClearLight will utilize proprietary methods for tissue processing and 3D light-sheet microscopy, to develop biomarkers to map key aspects of the microenvironment of human pancreatic cancer.  Press release

HudsonAlpha Institute for Biotechnology has diagnosed more than 100 children through the Clinical Sequencing Exploratory Research project (CSER), which works to identify genetic diagnoses for children with intellectual disabilities and developmental delay. The announcement was made when HudsonAlpha scientists, collaborators, patients and their families gathered at the Institute to celebrate the achievement. Press release