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Genetics & Genomics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

CDC Combined COVID-19/Influenza Test Gets FDA Emergency Use Authorization

The real-time RT-PCR multiplex test is intended for the simultaneous detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus.

Centogene Gets Emergency Use Authorization for PCR-Based Coronavirus Test

Earlier this month Centogene said that previously acquired laboratory space in Hamburg is now exclusively performing SARS-CoV-2 testing.

FDA Grants EUAs for PCR Coronavirus Tests, Nasal Swab Self-Collection Kit

The tests were developed by Psomagen, Acupath Laboratories, and BioTNS, and the nasal swab self-collection kit is offered by Kroger Health.

FDA Grants Emergency Use Authorization for LifeHope Labs Coronavirus Test

The PCR-based test is based on the US Centers for Disease Control and Prevention's CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel.

FDA Grants Emergency Use Authorization for Inform Diagnostics Coronavirus Test

The test is based on the US Centers for Disease Control and Prevention's SARS-CoV-2 panel and detects two regions of the virus' nucleocapsid gene.

Jun 26, 2020

FDA Grants Emergency Use Authorization for PreciGenome, PlexBio Coronavirus Tests

Jun 26, 2020

PathoFinder Gets CE Mark for Second SARS-CoV-2 PCR Test

Jun 26, 2020

Diagnostic Solutions Laboratory, MD Anderson Coronavirus Tests Get FDA Emergency Use Authorizations

Jun 25, 2020

FDA Issues EUAs for University of Alabama, HealthQuest Esoterics Coronavirus Tests

Jun 24, 2020

FDA Grants Emergency Use Authorizations for Gencurix, Laihe Biotech Coronavirus Tests

Jun 19, 2020

FDA Grants EUAs for Coronavirus Tests from 3B Blackbio, Ohio State, and Others

Jun 18, 2020

FDA Approves Epizyme's Tazverik, Roche CDx for EZH2-Mutated Follicular Lymphoma Patients

Jun 17, 2020

FDA Allows Emergency Use of Applied BioCode, Kaiser Permanente, Emory University Coronavirus Tests

Jun 17, 2020

FDA Approves Merck's Keytruda, Foundation Medicine CDx for TMB-High Solid Tumors

Jun 15, 2020

Yourgene Health Gets CE Mark for Iona NIPT Test

Jun 15, 2020

NeuMoDx Molecular Nabs CE Mark for HIV Viral Load Assay

Jun 15, 2020

DiaSorin Molecular Gets CE Mark for Congenital CMV Assay

Jun 15, 2020

FDA Grants EUAs for RTA Laboratories, Cormeum Laboratory Services Coronavirus Tests

Jun 12, 2020

RenalytixAI Receives Approval From New York State to Offer Kidney Test

Jun 12, 2020

FDA Grants EUAs for Coronavirus Tests From Cue Health, Tide Laboratories, TBG Biotechnology

Jun 10, 2020

ChromaCode Receives FDA Emergency Use Authorization for SARS-CoV-2 PCR Test

Jun 10, 2020

Sysmex Obtains Japan Marketing Approval for Use of Saliva With Coronavirus Kit

Jun 08, 2020

QuantuMDx Receives CE-IVD Marking for SARS-CoV-2 Test

Jun 08, 2020

FDA Grants Emergency Use Authorizations for Phosphorus Diagnostics, Genetron Coronavirus Tests

Jun 05, 2020

FDA Issues Emergency Use Authorization for University of Nebraska Medical Center Coronavirus Test

More articles

The Scan

Working Out the Effect

The Washington Post reports on researchers' efforts to determine the effect of an increasingly common SARS-CoV-2 mutation.

Increased Genetic Privacy in Florida

Florida Politics reports Florida's law barring life, long-term care, and disability insurers from using genetic information in coverage decisions went into effect at the beginning of July.

Attention-Grabbing in Two Ways

A new analysis finds a link between popular media coverage of a scientific study and how often that paper is cited.

Nature Papers Describe CRISPR Plant Editing Methods, DNA-PAINT Improvements, More

In Nature this week: CRISPR approaches to editing plant genomes, way to speed up DNA-PAINT, and more.

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In Regulatory News & FDA Approvals

  1. Centogene Gets Emergency Use Authorization for PCR-Based Coronavirus Test

  2. CDC Combined COVID-19/Influenza Test Gets FDA Emergency Use Authorization

  3. FDA Grants EUAs for PCR Coronavirus Tests, Nasal Swab Self-Collection Kit

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