The test, which may be performed only by labs CLIA certified to perform high- or moderate-complexity tests, runs on the company's DZ-lite 3000 Plus CLIA Analyzer.
Roche announced on Thursday that two of its tests for Alzheimer's disease have received 510(k) clearance from the US Food and Drug Administration. The Elecsys Beta-Amyloid (1-42) CSF II and Elecsys ...
High payment rates for tests for rare disorders in regions covered by two Medicare Administrative Contractors could spark debate about genetic testing fraud.
Despite a few less successful elements, the overall portfolio increased test availability and RADx is now becoming a model ...
This month's clearances include assays for congenital cytomegalovirus infection, hepatitis C infections, genetic diseases in newborns, and hemostasis measurements.
National Institutes of Health-funded project is coordinating hundreds of researchers with goals of determining the causes and ...
The marketing authorization makes Thermo Fisher’s SeCore CDx HLA Sequencing System the first and so far only commercially available HLA typing companion diagnostic.
The report found that 378 labs out of 19,577 billed Medicare Part B for large amounts of add-on respiratory and other testing with their COVID-19 tests.
The ReconAAsense trial will enroll 15,000 patients to measure the clinical performance of the firm's combined mRNA, DNA, and fecal immunochemical test.
The company plans to purchase common shares through open market, privately negotiated, or other means for up to 24 months.
National Institutes of Health-funded project is coordinating hundreds of researchers with goals of determining the causes and ...
The firm will evaluate its epigenomic liquid biopsy test to detect pancreatic cancer among patients considered high-risk for the disease due to their diabetes.