23andMe Clears Big Hurdle

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23andMe Clears Big Hurdle

The FDA authorized the marketing of 23andMe’s Bloom Syndrome carrier test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder. The announcement comes amid the rise of a fledgling industry aiming to sell consumers personalized genetic information. Some excerpts and links of the approval’s media coverage:

23andMe finally wins FDA approval for a genetic health test -Venture Beat
“Fourteen months after having its genetic health tests ordered from the market by the U.S. Food and Drug Administration, 23andMe today won a huge victory both for itself and for consumer genetic testing by receiving FDA approval to market a single genetic test for a disorder called Bloom Syndrome.”

F.D.A. Eases Access to DNA Tests of Rare Disorders – New York Times
“The agency also said that, in general, such so-called carrier tests would no longer need to be approved in advance before being marketed. It also voiced support for allowing consumers in some situations to have direct access to genetic testing, without a doctor being involved.”

In Big Shift, FDA Plans To Let 23andMe Market Genetic Tests To Consumers – Forbes
“It’s not yet clear how sweeping the FDA’s move is, and it may not happen all that soon. It still needs to come out with a specific notice of what it intends to require, which will be followed by a 30-day public comment period and then implementation.”

U.S. FDA approves 23andMe’s genetic screening test for rare disorder – Reuters
“The current approval is for a much narrower slice of the genetic testing market. “The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information,” Alberto Gutierrez, director of the FDA’s office of in vitro diagnostics and radiological health said in a statement.”

FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome – FDA
“Like other home-use tests for medical purposes, the FDA requires the results to be conveyed in a way that consumers can understand and use. This is the same approach the FDA has taken with other over-the-counter consumer products such as pregnancy, cholesterol and HIV tests for home use.

While the FDA is not limiting who should or should not use these tests, it is requiring that the company explain to the consumer in the product labeling what the results might mean for prospective parents interested in seeing if they carry a genetic disorder.”

A Note to Our Customers Regarding the FDA – 23andMe
“The FDA has been incredibly responsive throughout our review and the agency has demonstrated its support for direct to consumer genetic testing. We will continue to work with the FDA to ensure that all future health submissions meet the agency’s standards.”

February 20th, 2015|