FDA Spanks 23andMe, Grants Breakthrough Status To Factor Xa Inhibitor, and Approves Promus Premier Stent

It was a busy morning at the FDA. Three new FDA actions may be of considerable interest in the cardiology universe:

FDA Halts 23andMe Personal Genome Test– The FDA sent a scathing letter to 23andMe ordering the company to stop selling its Personal Genome Service (PGS) test.   The FDA highlighted two cardiology-related uses of PGS as “particularly concerning,” including drug responses involving warfarin sensitivity and clopidogrel response.

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FDA Grants Breakthrough Status To Factor Xa Inhibitor Antidote–

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FDA Approves Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System–

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Click here to read the full story on Forbes.