FDA Watch: Expanded Label Clearance Opens Cologuard to a Younger Market

FDA Watch: Expanded Label Clearance Opens Cologuard to a Younger Market

September was an eventful month for one of the hottest products on the consumer genetic test market, the Cologuard multi-target stool DNA test (mtSDNA) for colorectal cancer screening produced by Exact Sciences. The month started badly with the release of a CMS-sponsored research report finding Cologuard “less effective and considerably more costly” than alternatives. Although Exact Sciences quickly criticized the report and its analytical methodology, its stock took a beating.

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Inside the Diagnostics Industry: New Government BRCA Test Guidelines Are a Mixed Bag for Genetic Testing Labs

Inside the Diagnostics Industry: New Government BRCA Test Guidelines Are a Mixed Bag for Genetic Testing Labs

From - Diagnostic Testing & Emerging Technologies
The US Preventive Services Task Force (USPSTF) issued updated recommendations for BRCA-related cancer risk assessment…


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