Zepto Life Technology has announced the launch of the FungiFlex® Mold Panel, a plasma-based molecular diagnostic test now ...

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 ...

CMS has issued a final rule that gives the agency greater discretion in enforcing the Clinical Laboratory Improvement Amendments, according to the Taking Essential Steps for Testing Act of 2012. Under ...

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 ...

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 ...

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 ...