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Genetics & Genomics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The company said that three of its clinical laboratories have passed a COVID-19 external quality assessment by China's National Center for Clinical Laboratories.

The assay is a real-time RT-PCR test designed for the qualitative detection of specific sequences of the SARS-CoV-2 N gene in respiratory specimens.

The PCR-based test is designed to detect the nucleocapsid gene of the SARS-CoV-2 virus in nasal, nasopharyngeal, and oropharyngeal swab specimens.

Luminex said that with two FDA EUAs it is now providing SARS-CoV-2 diagnostic tests for high-complexity, high-throughput labs and moderate-complexity testing facilities.

The PCR-based test, which recently received CE-IVD marking, uses Co-Diagnostics' CoPrimer technology to detect the RdRp gene of the SARS-CoV-2 virus.

Los Angeles brought and settled a civil enforcement action against the makers of an at-home test for SARS-CoV-2, NPR reports. 

The Guardian reports that Cancer Research UK is cutting its research funding by £44 million.

Technology Review examines factors affecting SARS-CoV-2 testing turnaround times.

In PNAS this week: mapping of ancient human migrations in Europe, recurrent gene fusion in breast cancer, and more.