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Life Sciences › 23andMe › Genetic Testing

Fox Rothschild LLP

Some Resources & Updates Relating to Genetic Testing for Paternity

Fox Rothschild LLP on

We have written a couple of times about the 23&Me phenomenon and the chance that those who enter this unknown world come back not just surprised but possibly creeped out by their quest for ancestral knowledge. USA Today...more

Robinson+Cole Data Privacy + Security Insider

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

Robinson+Cole Data Privacy + Security Insider on

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

Houston Harbaugh, P.C.

23andMe Hack: The Legal Fallout From the Breach and What it Means in PA

Houston Harbaugh, P.C. on

In October of 2023, a hacker claimed online that they had 23andMe users’ profile information. We know this as a result of 23andMe’s required statement to the U.S. Securities and Exchange Commission (SEC) on December 1, 2023. ...more

Wyrick Robbins Yates & Ponton LLP

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

Wyrick Robbins Yates & Ponton LLP on

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

Patterson Belknap Webb & Tyler LLP

FDA Authorizes First Direct-to-Consumer Test for BRCA Gene Mutations

Patterson Belknap Webb & Tyler LLP on

On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). ...more

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP on

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

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