Labroots

Analytical and Clinical Validation Requirements for Next Generation Sequencing Laboratory-Developed Tests

Next generation sequencing (NGS) has revolutionized molecular diagnostic testing. It is important to note that, as with many molecular diagnostic tests currently in clinical use, there are very few ...
Nature

Molecular genetic testing for ultra rare diseases: models for translation from the research laboratory to the CLIA-certified diagnostic laboratory

Clinical Laboratory Improvement Amendments (CLIA)-certified clinical molecular diagnostic laboratory—a molecular diagnostic laboratory that has obtained formal certification through CLIA, 1 under the ...
The New England Journal of Medicine

Covid-19 Molecular Diagnostic Testing — Lessons Learned

On February 4, 2020, the U.S. secretary of health and human services declared that emergency use of diagnostics for SARS-CoV-2 was justified, triggering emergency authority for the Food and Drug ...
GEN

Synergy Holds Key in Molecular Diagnostics

PCR continues to revolutionize molecular diagnostics. Its ability to enrich genomic regions of interest for next-generation sequencing (NGS) and interface with other technologies such as mass ...
Business Wire

Aptorum Group Updates on the Clinical Validation of RPIDD Infectious Disease Liquid Biopsy Molecular Diagnostics

NEW YORK & LONDON & PARIS--(BUSINESS WIRE)--Regulatory News: Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) a clinical stage biopharmaceutical company dedicated to tackling unmet medical ...