Genetics & Genomics Regulatory News

The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.

Applied BioCode Gets CE Mark for MDx Platform, GI Panel

The company submitted the platform and gastrointestinal panel to the US Food and Drug Administration for clearance earlier this year.

FDA Expands Approval of Roche Cobas Test as CDx for EGFR Deletions, Mutations

The FDA approved its use with tissue or plasma biopsies, giving clinicians a non-invasive option to conduct a test that provides results in a day.

Curetis Gets CE Mark for UTI Test

The test cartridge runs on the company's Unyvero platform and covers 103 diagnostic targets for various pathogens and markers of antibiotic resistance.

FDA Clears Roche CT/NG Assay for 6800, 8800 Systems

The firm said that its Cobas CT/NG real-time PCR assay is the first available in the US for the testing of sexually transmitted infections on its 6800 and 8800 systems.

Cancer Genetics Wins 510(k) Clearance for Tissue of Origin Test

The test is designed to identify a tumor's tissue of origin by assessing 2,000 individual genes and covers 15 common tumor types.

Apr 12, 2018

FDA Finalizes NGS Guidances; Proposes Guidance on Investigational IVDs in Cancer Rx Trials

Apr 04, 2018

Curetis Unyvero System, Lower Respiratory Tract Infection Cartridge Get FDA Clearance

Apr 02, 2018

Japanese Regulators Approve Myriad Genetics' BRACAnalysis Test

Mar 28, 2018

Fast Track Diagnostics Gets CE Mark for Real-Time PCR Detection of High-Risk HPV

Mar 15, 2018

Castle Bio Gets NY State Approval for Three Cancer Tests

Mar 08, 2018

FDA Should Facilitate Lab Test Innovation, Craft Long-Term Regulatory Overhaul, Gottlieb Says at ACLA

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Mar 07, 2018

Oncology Community Sees Potential for Patient Harm in FDA OK of 23andMe BRCA Test

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Mar 06, 2018

Clinical Genomics Licensed to Offer Tests in Florida

Mar 06, 2018

FDA Authorizes 23andMe DTC Test Report for Three BRCA Mutations

Mar 06, 2018

Qiagen Trichomonas Assay Gets CE Mark

Mar 02, 2018

BloodPAC Moves Forward With Liquid Biopsy Data Commons

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Feb 21, 2018

New York State Accredits DermTech

Feb 20, 2018

BD Gets CE Mark for Circulating Cell-Free DNA Blood-Collection Tube

Feb 13, 2018

FDA Clears Roche Factor II, Factor V Gene Mutation Test for Inherited Thrombophilia

Feb 13, 2018

FDA Approves BD HPV Genotyping Test

Feb 12, 2018

NantHealth Submits GPS Cancer Test to FDA, Debuts AI Platform for Tumor ID

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Feb 08, 2018

Vela Diagnostics HSV Test Gets FDA Clearance

Feb 07, 2018

Mesa Biotech Gets FDA Clearance, CLIA Waiver for Flu A/B Test and POC System

Feb 06, 2018

Qiagen Garners CE Mark for PITX2 Test to Guide Breast Cancer Treatment

Feb 06, 2018

Curetis Gets Singapore Approval for Pneumonia Test