FDA Lifts Some Regulatory Hurdles for Genetic Health Risk Tests as Planned

Jun 05, 2018

NEW YORK (GenomeWeb) – Late last week, the US Food and Drug Administration lifted some regulatory hurdles for makers of direct-to-consumer genetic health risk tests. After obtaining a first premarket authorization for a genetic health risk (GHR) test, manufacturers can now commercialize new tests without additional review.

To read the full story....

...and receive Daily News bulletins.

Already have a 360Dx or GenomeWeb account?
Login Now.

Don't have a 360Dx or GenomeWeb account?
Register for Free.

Menu

FDA Lifts Some Regulatory Hurdles for Genetic Health Risk Tests as Planned

To read the full story....

Breaking News

Palmetto Expands Coverage for Decipher Biosciences Prostate Cancer Test

Cepheid Multiplex SARS-CoV-2, Flu, RSV Test Nabs FDA Emergency Use Authorization

ASU Team Wins $6M in Government Funding to Develop Rapid Saliva Testing System for Coronavirus

Biovica Files FDA 510(k) Submission for Breast Cancer Treatment Response Assay

Genetron, CStone Launch Clinical Trial to Develop CDx for Cancer Drug Avapritinib

Natera Cancer Liquid Biopsy Test Coverage to Expand Under New Draft LCD

Featured White Papers

Moving from Non-Invasive Prenatal Screening to Prenatal Diagnostics: An Expert Panel Discussion

Navigating the FDA's EUA Process for Diagnostics in the Present and Future: A Stakeholder Panel Discussion

What's Popular?

Cepheid Multiplex SARS-CoV-2, Flu, RSV Test Nabs FDA Emergency Use Authorization

FDA Revises Emergency Use Authorization for Abbott Point-of-Care SARS-CoV-2 Test

ASU Team Wins $6M in Government Funding to Develop Rapid Saliva Testing System for Coronavirus

United Airlines Launches COVID-19 Testing Program for Travelers to Hawaii

Abacus Diagnostica Readying Multiplex RT-PCR Test for SARS-CoV-2, Flu, RSV

Sponsorships