BioGX's expanded flu/RSV test gets CE-IVD Mark
October 23, 2019 -- BioGX announced that its new automated polymerase chain reaction test for influenza A, influenza B, and respiratory syncytial virus (RSV) has received the CE-IVD Mark.
Danaher divests lab business units to Sartorius for $750M
October 21, 2019 -- Danaher is selling parts of its life science portfolio -- including its FortéBio label-free biomolecular characterization business -- to Sartorius for $750 million in cash to help satisfy regulatory requirements related to its acquisition of GE's biopharmaceutical business.
Ortho Sera extended blood typing clears FDA
October 18, 2019 -- Ortho Clinical Diagnostics has announced the U.S. Food and Drug Administration (FDA) clearance of its Ortho Sera ID-Micro Typing System (MTS) extended antigen phenotyping in blood transfusion products, for use on the company's Ortho Vision analyzer.
Singapore sequencing project maps genes in Asians
October 18, 2019 -- Whole-genome sequencing data for almost 5,000 people in Singapore were published on October 17 in the journal Cell, in what the researchers described as the largest genetic study of Asian populations in the world.
Invitae warns of false negatives on consumer tests
October 18, 2019 -- Direct-to-consumer genetic tests that provide limited screening put people at risk for false-negative results, according to a study by Invitae presented at the American Society of Human Genetics annual meeting held October 15-19 in Houston.
NIH test inspects abnormal tau in cerebrospinal fluid
October 17, 2019 -- A new test for abnormal tau in cerebrospinal fluid has potential for diagnosing a range of neurodegenerative conditions, researchers from the U.S. National Institutes of Health (NIH) concluded in a study published online October 16 in Acta Neuropathologica.
NeuMoDx adds HPV test with pathology spin-off Self-screen
October 17, 2019 -- NeuMoDx is working with the Netherlands-based biotech spin-off Self-screen on a CE-IVD Marked test for high-risk HPV that is compatible with its NeuMoDx 288 and 96 models.
Cleveland Diagnostics' prostate cancer blood test gets breakthrough status
October 16, 2019 -- Cleveland Diagnostics' IsoPSA blood test for prostate cancer has been designated by the U.S. Food and Drug Administration as a breakthrough device, which allows greater collaboration with officials and typically a faster regulatory review.
New AncestryHealth features physician-ordered tests in CLIA labs
October 15, 2019 -- Ancestry is adding genetic profiling to its offerings, with a focus on tests ordered by physicians and performed in CLIA-certified laboratories in the U.S.
Novigenix drafted for neuroendocrine tumor blood test
October 15, 2019 -- Novigenix is working with radiopharmaceutical company RadioMedix to develop a molecular test that can detect neuroendocrine tumors early and predict treatment response.