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Genetics & Genomics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

Cepheid, Roche Coronavirus Tests Get FDA Emergency Use Authorization

The FDA last week also reissued an EUA for a PCR-based SARS-CoV-2 test from Quest Diagnostics to permit its use with pooled samples.

FDA Reissues EUA for Stanford Health Care Coronavirus Test to Include Self-Collected Nasal Swabs

The RT-PCR-based test was first authorized earlier this year for the detection of SARS-CoV-2 nucleic acid in specimens collected by a healthcare provider.

FDA Issues EUAs for Gravity Diagnostics Coronavirus Test, Sample Self-Collection Kit from RapidRona

The FDA also reissued Emergency Use Authorizations for SARS-CoV-2 tests from Roche and Express Gene to reflect their permitted use with additional sample types.

Cepheid Receives CE Mark for SARS-CoV-2, Flu A/B, RSV Combination Test

Cepheid said that the 4-in-1 test runs on any of almost 30,000 GeneXpert Systems, which provide results in approximately 36 minutes.

Zymo Research Gets CE-IVD Mark for Viral Nucleic Acid Purification Kit

The kit is designed for use with samples stored in the company's CE-marked DNA/RNA Shield sample collection and preservation devices.

Nov 23, 2020

FDA Accepts Invitae Premarket Approval Submission for Stratafide Companion Diagnostic

Nov 20, 2020

Hologic Receives Additional FDA Approval for Diagnostic Use of HIV-1 Viral Load Test

Nov 19, 2020

PathoFinder Obtains CE Mark for Two Multiplex SARS-CoV-2 MDx Tests

Nov 18, 2020

Bioneer Gets CE-IVD Marks for Combination Coronavirus, Flu Assays

Nov 18, 2020

FDA Grants Emergency Use Authorization to First At-Home COVID-19 Test From Lucira Health

Nov 17, 2020

Co-Diagnostics Q3 Revenues Soar on Coronavirus Test Sales as Firm Gains Two More CE Marks

Nov 16, 2020

Qiagen Obtains CE Mark for Multiplex Respiratory Infection Test, Saliva-Based SARS-CoV-2 Assay

Nov 13, 2020

FDA Approves Merck's Keytruda, Agilent CDx in PD-L1-High Triple-Negative Breast Cancer

Nov 10, 2020

Zymo Research Gets CE-IVD Mark for SARS-CoV-2 Multiplex Kit

Nov 09, 2020

FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Lynparza

Nov 05, 2020

LabCorp Coronavirus Test EUA Reissued to Expand Sample Types for Pooled Testing

Nov 04, 2020

FDA Reissues Color Coronavirus Test EUA for Sample Collection Changes

Nov 02, 2020

Regulatory Documents for Newly Approved Liquid Biopsy NGS Panels Detail Diverse Test Claims, Methods

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Nov 02, 2020

DNA Genotek Gets FDA Emergency Use Authorization for Saliva Collection Devices

Oct 30, 2020

Credo Diagnostics Combo Influenza, COVID-19 Test Receives CE-IVD Mark

Oct 29, 2020

Roche EGFR Mutation Test Approved by FDA as Companion Diagnostic for NSCLC

Oct 28, 2020

Agena Bioscience Gets FDA Emergency Use Authorization for MassArray Coronavirus Test

Oct 27, 2020

FDA Reissues EUA for Broad Institute Coronavirus Test, Authorizes Immunoassay From Celltrion

Oct 27, 2020

FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Three Targeted Therapies

Oct 26, 2020

FDA Approves Foundation Medicine CDx, Bayer's Vitrakvi for NTRK Patients