The effort, called SepTech, will begin on Sept. 1 and run through August 2029, and it picks up from an earlier project called ECLIPSE.

NEW YORK – Roche announced on Wednesday that it has received US Food and Drug Administration approval for the expanded use of two companion diagnostic tests with Jazz Pharmaceuticals' Ziihera ...

The firm recently raised $15 million in seed financing to further validate and commercialize its pathogen detection and antimicrobial resistance profiling platform. Recent catalysts such as an FDA ...

The test is intended to support rule-in and rule-out assessment of amyloid pathology across primary and specialty care settings.

NEW YORK — Proscia said on Thursday that its Concentriq AP-Dx digital pathology software has received 510(k) clearance from the US Food and Drug Administration for use with Leica Aperio GT 450 DX ...

NEW YORK – Four years into implementation of the federal No Surprises Act (NSA), claims for clinical lab testing comprise a substantial proportion of bills being disputed under the law. And in the ...

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 – Congress is taking another stab at establishing formal timelines for local coverage determination (LCD) reviews by Medicare Administrative Contractors (MACs). Last month, Rep. Neal Dunn, ...

ANAHEIM, Calif. — Point-of-care firm Kompass Diagnostics took first place in the Disruptive Technology Award Competition at the Association for Diagnostics & Laboratory Medicine's annual meeting here ...

NEW YORK – Following de novo clearance this month of its combination influenza and COVID-19 lateral flow test for over-the-counter use, Houston-based Healgen Scientific expects to scale up ...

NEW YORK – Based on data generated in the National Lung Screening Trial (NLST) cohort, cancer testing firm Mercy BioAnalytics believes its lung cancer early detection assay can identify cancers missed ...

NEW YORK – During a webcast presentation at the 44 th Annual JP Morgan Healthcare Conference in San Francisco on Monday, Qiagen CEO Theirry Bernard projected a near-term revival of lab equipment ...