Previously, this blog covered the FDA’s decision to regulate lab-developed tests (LDTs) as medical devices.  However, ...

Outfront Health launches virtually painless at-home biomarker kits with lab analysis & secure portal, helping adults track performance & longevity.

Rapid urinary antigen testing is widely used for pneumonia diagnosis, yet it often lacks the consistency and traceability required in today’s clinical laboratories. This webinar explor ...

The Department of Public Health and Social Services is celebrating a milestone, the recertification of its Northern Region Community Health Center laboratory, which provides critical services to ...

U.S.-headquartered CRO Crown Bioscience’s San Diego laboratory has received Clinical Laboratory Improvement Amendments (CLIA) certification. This milestone enables Crown Bioscience to deliver clinical ...

Today, Inocras, a leader in whole genome sequencing (WGS) and bioinformatics, operating a CLIA/CAP-certified laboratory in San Diego, announced that its whole genome sequencing (WGS)-based cancer ...

Background: With the emergence of disease-modifying therapies for Alzheimer’s disease (AD), there is an urgent need for scalable, accurate, and well-validated blood test alternatives to positron ...

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...

The Food and Drug Administration did not appeal a recent U.S. District Court decision that set aside the agency’s final rule aimed at increasing its authority over laboratory developed tests, ...

NEW YORK – With its recent decision to discontinue the Clinical Laboratory Improvement Advisory Committee (CLIAC), the US Department of Health and Human Services (HHS) has shut down one of the ...