Crown Bioscience, a global contract research organization (CRO) and a JSR Life Sciences company, today announced that its San ...

To maintain the quality of laboratory testing, CLIA requires that laboratories performing moderate or high-complexity testing enroll in an approved proficiency testing program for independent ...

The CLIA-waived CitoCBC® expands patient access to quick CBC results in physician offices, pharmacies, and home care, enabling data-driven diagnostics. CBC is one of the most commonly requested lab ...

Nuclein’s DASH SARS-CoV-2 & Flu A/B Test, which is designed for use with the DASH Rapid PCR System, has gained the US Food and Drug Administration (FDA) 510(k) clearance, as well as a Clinical ...

QuidelOrtho Corporation QDEL recently announced that it has been granted a CLIA Waiver by the FDA, which applies to its new Sofia 2 SARS Antigen+ FIA (fluorescent immunoassay). The Sofia 2 SARS ...

STONY BROOK, N.Y.--(BUSINESS WIRE)-- Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that ...

The undertaking of research in human participants often includes development of clinical laboratory test results associated with an individual research participant. Depending in part on the specified ...

There are two organizations that play a complementary role in ensuring regulatory compliance in laboratory diagnostics and the development of at-home diagnostics. The Food and Drug Administration (FDA ...

The FDA cleared for commercial distribution a diagnostic panel that tests for multiple respiratory viral and bacterial infections on Feb. 3. The BioFire Spotfire Respiratory Panel is the first ...