News & Analysis as of

23andMe

FDA Approval of 23andMe Genomic Test Shows the Way for Direct-to-Consumer Diagnostics

On April 6, 2017 the FDA Center for Devices and Radiological Health formally approved 23andMe’s Personal Genome Services Test as a Class II Medical Device. Approved tests include assessment of an individual’s genetic risk of...more

FDA Relents, Grants Premarket Authorization to 23andMe Genetic Diagnostics Test

On April 6th, the U.S. Food and Drug Administration (FDA) continued to loosen the reins on the genetic diagnostic and DNA analysis company 23andMe with regarding to direct-to-consumer (DTC) genetic testing related to...more

FDA Cleared First DTC Genetic Tests for Health Risks

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

23andMe Receives FDA Approval for Genetic Diagnostic Test

Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare...more

Direct-to-Consumer Genetic Test Authorized by FDA

by Foley & Lardner LLP on

23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order...more

Blog: 23andMe Advances Its Goal of Creating Commercialized Database from Consumer Genetic Testing

by Cooley LLP on

On January 12, 23andMe announced an agreement with Pfizer to provide the drug company with access to anonymous, aggregated information from consumers who bought 23andMe’s test over the past seven years to learn about their...more

More Q&A from Webinar on Top Patent Law Stories of 2013

On Tuesday, we presented a live webinar on the "Top Patent Law Stories of 2013." The webinar covered ten of the fourteen stories that made it onto Patent Docs seventh annual list of top biotech/pharma patent stories. Posts...more

Top Stories of 2013: #11 to #14

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more

Why a Class Action Lawsuit Against 23andMe? Quick Hit Q&A With Audet & Partners

by JD Supra Perspectives on

The bad news for 23andMe keeps coming. In late November, we learned that the U.S. Food and Drug Administration had ordered the company to stop selling its $99 DNA testing kit owing to a number of accuracy and validity...more

23andMe Named in Class Action Lawsuit

Things are getting worse for genetic diagnostics company 23andMe. On the heels of receiving a Warning Letter from the FDA over its Personal Genomic Services (PGS) test (see "FDA Threatens Agency Action Against 23andMe Over...more

Patients Push Back on FDA Threats to 23andMe Genetic Testing Products

In a petition published on the "We the People" portion of the White House website, a group of self-titled healthcare consumers call for the Obama Administration to overrule the FDA and permit genetic testing company 23andMe...more

FDA and 23andMe: Innovation Will Never Prevail If the Innovator Fails to Properly Manage Their Relationship with the Regulator

by JD Supra Perspectives on

The FDA order against 23andMe to stop genetic testing shows that in the balance between regulation and innovation, innovation will never prevail if the innovator fails to properly manage its relationship with the...more

Health Care Reform Update -- November 25, 2013

In This Issue: Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; and Hearings and Mark-Ups Scheduled. Excerpt from...more

FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing

As reported in Fierce Medical Devices by Damian Garde, the FDA has issued a Warning Letter to personal genomics company 23andMe, demanding that the company stop selling its Personal Genomic Services (PGS) product without...more

The FDA Order Against 23andMe Shows That in the Balance Between Regulation and Innovation...

by JD Supra Perspectives on

The FDA order against 23andMe to stop genetic testing shows that in the balance between regulation and innovation the FDA occasionally must address an age old debate...more

Bioethicists "Urge Maximal Transparency" in Response to 23andMe Patent

Last week, we discussed a patent, recently issued to 23andMe, Inc., that has created some controversy. The patent, U.S. Patent No. 8,543,339, is directed to a system for identifying a preferred gamete donor from among the...more

23andMe Patent Creates Controversy

A patent issued to 23andMe, Inc. last month has created some controversy, and in response, the biotech company, based in Mountain View, California, has posted its side of the story on the 23andMe blog. The patent, U.S....more

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