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New Idylla Ebola Virus Triage Test Granted Emergency Use Authorization by U.S. FDA

As part of Johnson & Johnson’s commitment to combat Ebola, Janssen Pharmaceutica NV today announced that the Idylla™ Ebola Virus Triage Test (Idylla™ EBOV Test) was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA)[1]. The Idylla™ Ebola Virus Triage Test is a diagnostic that detects the presence of the Ebola Zaire virus in patients with signs and symptoms of Ebola virus disease and was jointly developed by Janssen Diagnostics, a division of Janssen Pharmaceutica, Biocartis NV (Biocartis), and the Belgium Institute of Tropical Medicine.

LabCorp Announces the Launch of the Epi proColon Test for Colorectal Cancer Screening

Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) today announced the launch of Epi proColon®, a blood-based test for colorectal cancer screening that was approved on April 13, 2016 for clinical use by the U.S. Food and Drug Administration (FDA). Epi proColon® is the first FDA-approved DNA based blood test for colorectal cancer. The test was developed by Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) and is available under a joint commercialization agreement with Polymedco, Inc. in North America. LabCorp, the world’s leading healthcare diagnostics company, is the first laboratory in the U.S. to offer this FDA-approved, blood-based colorectal cancer screening test.

VolitionRx Announces CE Marks for Two NuQ Blood Assays for Detection of Colorectal Cancer

VolitionRx Limited (NYSE MKT: VNRX) recently announced CE marking for two blood-based diagnostic assays for the detection of colorectal cancer. The biomarker assays, NuQ®V001 and NuQ®T003, identify and analyze fragments of chromosomes, called nucleosomes, circulating within the blood for the presence of cancer signatures.

NX Prenatal Premature Birth Biomarker Study Published in Prestigious American Journal of Obstetrics and Gynecology

NX Prenatal, Inc. recently announced that the American Journal of Obstetrics and Gynecology (“AJOG”) published a manuscript entitled, “Evaluation of proteomic biomarkers associated with circulating microparticles as an effective means to stratify the risk of spontaneous preterm birth,” from a clinical study evaluating blood-based biomarkers in pregnant mothers. In the study, candidate biomarker panels comprised of exosome-associated proteins evaluated at week 10-12 of gestation were shown to effectively differentiate groups women who go on to deliver spontaneously at less than 34 weeks versus term delivering controls (≥ 37 weeks).

200 Million Americans Now Have Insurance Coverage for Biodesix’s VeriStrat Test; BCBS of FLorida and Health Services Corporation Issue Positive Coverage Decisions

VeriStrat®, Biodesix’ proteomic blood test for patients with advanced NSCLC, has received multiple positive coverage decisions in 2016. As a result, 200 million Americans now have insurance coverage for VeriStrat. The most recent positive coverage decisions include BlueCross BlueShield (BCBS) of Florida and Health Care Services Corporation (HCSC).