COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

COVID-19 Briefings

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

FDA Issues Second EUA for Whole Genome Sequencing COVID-19 Diagnostic Test

FDA maze of regulations

New EUA issued for COVID-19 diagnostic test that can also be used to monitor for viral mutations

The US Food and Drug Administration (FDA) announced the issuance of an emergency use authorization (EUA) for a whole genome sequencing test used to diagnose COVID-19. This EUA marks only the second authorization for a COVID-19 diagnostic test that sequences the entire viral genome.

The SARS-CoV-2 NGS Assay by Twist Bioscience Corporation is a next-generation sequencing (NGS)-based test that sequences the full genome of SARS-CoV-2 RNA and is used to diagnose COVID-19. The whole genome testing technology that this test utilizes not only diagnoses the presence of COVID-19 but can also provide information about viral variants and is not affected by mutations that may occur.

While there are many high-throughput diagnostic tests available for COVID-19, our solution enables clinicians and researchers the ability to sequence and surveil the evolution of mutations in the virus over time and geography. This is especially significant at the moment as more variants are identified that are more contagious,” said Emily M. Leproust, PhD, CEO and Co-founder of Twist Bioscience, in a statement. Importantly, while many labs are conducting individual sequencing runs for each patient sample, this assay and the accompanying software provide a way to batch about 100 samples together, providing actionable information that can then be used to inform public health and clinical decisions.”

This new EUA provides clinical laboratories with access to new diagnostic technologies that include monitoring capabilities for emerging SARS-CoV-2 variants.

Related Resources:

FDA EUA Letter:  SARS-CoV-2 NGS Assay