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Genetics & Genomics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

Genetron Health Gets CE Mark for Coronavirus PCR Test

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.

FDA Issues Emergency Use Authorization for Viracor Eurofins Coronavirus LDT

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.

FDA Issues Emergency Use Authorization for Gnomegen Coronavirus Test

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 Receives FDA Emergency Use Authorization for Second SARS-CoV-2 Assay

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.

Co-Diagnostics Gets FDA Emergency Use Authorization for Coronavirus Test

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.

Apr 03, 2020

Becton Dickinson, BioGX Get FDA Emergency Use Authorization for Rapid SARS-CoV-2 Test

Apr 02, 2020

Siemens Healthineers Developing Molecular Kit for Coronavirus Detection

Apr 02, 2020

Ipsum Diagnostics Coronavirus Test Gets FDA Emergency Use Authorization

Apr 01, 2020

FDA Releases New EUA Guidance for MDx Labs Offering SARS-CoV-2 Testing

Apr 01, 2020

FDA Proposes Reclassification of HCV RNA, Antibody Tests

Apr 01, 2020

Genetic Signatures Gets CE Mark for Coronavirus Molecular Test

Mar 31, 2020

Qiagen Receives FDA Emergency Use Authorization for SARS-CoV-2 Respiratory Panel

Mar 30, 2020

Rendu Biotechnology Gets Emergency Approval in China for Coronavirus Detection Kit

Mar 30, 2020

Myriad Genetics Seeks Japan Approval for Advanced Pancreatic, Prostate Cancer Companion Diagnostic

Mar 27, 2020

Abbott POC Coronavirus Test Snares FDA Emergency Use Authorization

Mar 27, 2020

Luminex Receives FDA Emergency Use Authorization for Coronavirus Multiplex Panel

Mar 27, 2020

Sysmex Obtains Japan Marketing Approval to Distribute BGI Genomics Coronavirus Kit

Mar 27, 2020

Avellino Labs Receives FDA Emergency Use Authorization for Coronavirus Test

Mar 26, 2020

Fosun Long March Gets Chinese Regulatory Approval for Coronavirus MDx Kit

Mar 26, 2020

Thermo Fisher Scientific COVID-19 Test Receives CE Mark, Expanded FDA EUA

Mar 25, 2020

Quidel SARS-CoV-2 Test Receives Expanded FDA Emergency Use Authorization

Mar 24, 2020

PerkinElmer Coronavirus Assay Gets FDA Emergency Use Authorization

Mar 24, 2020

BioMérieux Rapid Coronavirus Test Gets FDA Emergency Use Authorization

Mar 24, 2020

Mesa Biotech COVID-19 Test Receives FDA Emergency Use Authorization

Mar 24, 2020

GenoScreen Gets CE-IVD Mark for Tuberculosis Test