GAO
Seeking 510(k) Clearance for Genomic Testing Service, 23andMe Maintains Direct-to-Consumer Ethos
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Originally published July 31.
GAO Stands By Its 2010 Report on DTC Genomics Firms; Lead Investigator Assigned to New Position
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The Government Accountability Office squelched a rumor that has been circulating about the firing of an agency investigator due to errors in a report on for-profit colleges. Additionally, the agency said it has not "identified any problems" with a report on the DTC genomics industry that was led by the same investigator.
"The promise of genomics in the practice of medicine is great and exciting, but today the use of personal genomic tests is still not ready for prime time," a CDC official said in a video address to doctors and the general public.
In Wake of 'Flawed' GAO Report, Consumer Genomics Firms Call for Regulatory Plan for DTC Industry
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A week after being hit with a GAO report that called test results from consumer genetics firms "misleading," the big three DTC companies criticized the agency for using "unscientific" methods in its undercover investigation, but welcomed greater regulatory oversight.
FDA Tells Congress it is Mulling Strategies to Regulate DTC Genetic Tests as Medical Devices
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At a congressional hearing on DTC genomics this week, an FDA official acknowledged that the agency had waited too long to regulate this rapidly growing field. The agency said it is considering an "out-of-the-box approach" toward overseeing the consumer genomics industry.
Sep 30, 2009