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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

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

Foley & Lardner LLP

Direct-to-Consumer Genetic Test Authorized by FDA

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

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