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 ...

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 ...

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 ...

The onset of COVID-19 proved to be a real-time stress test of America’s clinical testing system. The experience exposed several flaws in the system that policymakers should address, specifically, ...

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 ...

High Expression of FGD3, a Putative Regulator of Cell Morphology and Motility, Is Prognostic of Favorable Outcome in Multiple Cancers In all, 142 (95%) of 150 questionnaires were completed by 38 ...

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 Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same ...

The UC Santa Cruz Colligan Clinical Diagnostic Laboratory (CCDL) has received its CLIA certificate of registration from the California Department of Public Health, which clears the way for it to begin ...

Leveraging metagenomics next-gen sequencing (mNGS), the Evvy Vaginal Health Test is the most comprehensive vaginal health test available. NEW YORK, Dec. 13, 2022 /PRNewswire/ -- Evvy, a female-founded ...