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Human Genes Genetic Testing 23andMe

Baker Botts L.L.P.

23andMe’s $30M Settlement: What It Means for Companies Handling Genetic and Genomic Data

Baker Botts L.L.P. on

The recent $30 million settlement between 23andMe and 6.4 million users following a major data breach offers important lessons for businesses dealing with sensitive genetic and genomic information....more

Fox Rothschild LLP

A 23&ME Update

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Valentine’s Day seemed an odd time to report the subject but CNN posted a five minute story provocatively titled as “I Slept with My Half Sibling.” This recounts the story of a Connecticut social worker who had symptoms of a...more

Robinson+Cole Data Privacy + Security Insider

Privacy Tip #385 – 23andMe Sends Letter to Data Breach Victims that Suing Over Breach is Futile

We previously alerted readers to the fact that the most recent data compromise of 23andMe exposed data related to Ashkenazi Jews and individuals of Chinese descent. It is reported by Ars Technica, citing TechCrunch, that...more

Wyrick Robbins Yates & Ponton LLP

California’s New Genetic Testing Law Applies to 23andMe – AND Me (or my Company)?

Last month, California Governor Gavin Newsom signed Senate Bill 41, the Genetic Information Privacy Act (“GIPA”), a law that regulates “direct-to-consumer genetic testing companies” that handle the “genetic data” of...more

Carlton Fields

How State and Federal Laws Are Addressing the Use of Direct-to-Consumer Genetic Testing by Insurance

Carlton Fields on

While life insurers traditionally have set premiums based on a multitude of complex actuarial tables, the recent boom in direct-to-consumer DNA testing produces, such as 23andMe and AncestryDNA, is expanding the universe of...more

Knobbe Martens

23andMe Wins FDA Approval for Test to Detect BRCA Mutations

Knobbe Martens on

The U.S. Food and Drug Administration (FDA) recently authorized 23andMe to market its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). According to an FDA news release, the approved...more

McDonnell Boehnen Hulbert & Berghoff LLP

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

Hogan Lovells

FDA Cleared First DTC Genetic Tests for Health Risks

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

JD Supra Perspectives

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

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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

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

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