The project, which is an initiative of the Quest Diagnostics Foundation, aims to expand healthcare access in the area, including through no-cost laboratory testing.

The guidelines address items like interpretation of results that may be affected by gender-affirming hormone therapy and improving electronic health record practices.

The agency cleared more than a dozen assays and instruments for microbiology, molecular biology, clinical chemistry, and other testing.

The PCR-based panels detect up to 22 of the most common bacteria, viruses, and parasites associated with gastroenteritis.

The company aims to complete the international development and validation of the test, as well as to obtain European regulatory approval and commercialize it as a service and a kit.

Last week, readers were most interested in a story about Achieve Diagnostics buying the pharmacogenomic assets of H&M Molecular Diagnostics.

The company will conduct a prospective, multicenter study enrolling approximately 954 men with elevated PSA levels who are scheduled for a prostate biopsy.

Thermo Fisher Scientific has launched LabScreen Single Antigen HLA Class II ExPlex – Group 2, a new panel that broadens human leukocyte antigen-DQ (HLA-DQ) coverage to support more complete antibody ...

NEW YORK – The Clinical Laboratory Improvement Amendments (CLIA) regulations are receiving renewed attention as both federal legislators and the US Centers for Medicare and Medicaid Services (CMS) ...

NEW YORK – As 2024 closed, the US Food and Drug Administration had — much to the chagrin of clinical labs — at last made good on its decades-long promise to regulate laboratory-developed tests (LDTs), ...

NEW YORK – The US Food and Drug Administration granted 20 in vitro diagnostics-related 510(k) clearances in April for devices and assays, including antimicrobial susceptibility, infectious diseases, ...