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23andMe
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The FDA Won't Let 23andme Sell Its Personal Genomic Service Tests
Jan 12, 2015The FDA won’t let 23andMe sell its Personal Genomic Service tests to consumers in the United States, but that hasn’t stopped the company from selling its customers’ anonymous information to other companies for research. ...
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23andMe Seems to Have Backed off in Its Claims Enough to Appease The Agency.
Apr 8, 201423andMe, the Mountain View, CA–based consumer DNA testing company that got in hot water with FDA over its lack of PMA approval for its testing for various medically significant genes, now seems to have backed off in its claims enough ...
Tags: Health, Medicine, FDA, certification
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Google Sent Several of Its Employees to Meet with Staff From FDA's Medical Device Branch
Jan 15, 2014Google recently sent several of its employees to meet with staff from FDA’s medical device branch. Bloomberg speculates that the new product could be tied to biosensors. The employees in question hail from the company’s Google ...
Tags: Medical Device, Google
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90%Women Needn't Receive Gene Test to See If They Are at Risk for Breast or Ovarian Cancer
Dec 25, 2013Nine of 10 women do not need and should not receive genetic testing to see if they are at risk for breast or ovarian cancer, an influential panel of health experts announced Monday. The U.S. Preventive Services Task Force (USPSTF) ...
Tags: breast cancer, ovarian cancer, women health, genetic testing
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Topol Has Cred When It Comes to Patient Safety
Dec 11, 2013A "misfire" is the way Eric Topol, MD, describes 23andMe's recent regulatory tussle with the FDA, which resulted in the Silicon Valley-based company halting sales for now of its health-related genetic test analysis. Speaking with MPMN ...
Tags: 23andme, FDA, regulatory tussle
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23andMe Says It Will Stop Selling Health-Related Genetic Test Analysis
Dec 6, 2013Under pressure from the FDA, 23andMe says it will stop selling health-related genetic test analysis until it has resolved its dispute with the federal regulatory agency. "We remain firmly committed to fulfilling our long-term mission to ...
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23andMe Halted All Marketing Last Week in Accordance with The FDA's Letter.
Dec 4, 2013More than a week after the FDA told 23andMe to stop marketing its Personal Genomic Service tests, the Mountain View, CA–based company says it is complying. "23andMe halted all marketing last week in accordance with the FDA’s ...
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FDA Is Telling 23andMe to Stop Marketing Its Personal Genomic Service Tests.
Nov 27, 2013Posted in Testing Services by Chris Newmarker on November 25, 2013 The FDA is telling 23andMe to stop marketing its Personal Genomic Service tests. The FDA’s move is but another sign that the regulator is increasingly concerned ...
Tags: 23andMe, DNA, Hit, FDA, warning letter
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FDA Halted The Selling of The 23andMe Saliva Collection Kit
Nov 27, 2013The U.S. Food and Drug Administration halted the selling of the 23andMe Saliva Collection Kit and Personal Genome Service -- a home DNA test. In a letter posted on its website, the FDA alleged 23andMe was being sold without clearance or ...