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Genetics & Genomics Regulatory News

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

The test detects Group A Strep in throat swab samples using the firm's rapid molecular diagnostics instrument called Revogene.

Abbott said that the MDx platform offers a number of initial assays, including tests for HIV-1, HBV, and HCV, among others.

The in vitro diagnostic uses next-generation sequencing to detect clinically actionable genetic variants to guide therapy selection for cancer patients.

The test is designed to identify and differentiate between Zika, dengue, and chikungunya in serum samples, even in the presence of more than one target.

Last year, the Gottlieb-led FDA approved 25 new molecularly-defined drugs and expanded indications compared to 19 in the prior year, and issued a slew of guidelines important for the personalized medicine field. 

Newsweek discusses the privacy issues raised by digital medicine.

A group of statisticians want to eliminate researchers' reliance on 'statistical significance,' according to NPR.

In Nature this week: genetic analysis of Anatolian farmers, cotton genome analysis, and more.

Matt Hancock, the UK health secretary, is calling for the swift rollout of predictive genetic tests, the Guardian reports.