Posts Tagged ‘testing’

November 25th, 2013

FDA Reprimands 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 […]

October 21st, 2010

INR Home Testing Found Comparable to Point-of-Care Testing

Weekly INR self-testing at home is comparable to monthly point-of-care testing, according to results of THINRS (the Home International Normalized Ratio Study), published in the New England Journal of Medicine. David Matchar and colleagues found no difference in the incidence of stroke, major bleeding episode, or death in the 2922 patients taking warfarin who were randomized to […]