Labroots

Analytical Validation of a Next Generation Sequencing Laboratory-Developed Test

Next-generation sequencing (NGS) has become the go-to tool for testing laboratories looking for increased efficiencies and profitability. NGS allows labs to use smaller tissue samples and reduced time ...
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 ...
Royal Society of Chemistry

Analytical Test Methods Validation for GxP Laboratory Compliance: FDA, ICH and USP Requirements - Webinar By GlobalCompliancePanel

This Validation training will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method ...
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 ...