FDA Bloom SyndromeTest Approval

[Caburn]

BBC News - 20 Feb 2015:

A Californian start-up will be allowed to advertise a mail order DNA test that screens for a rare genetic condition, after a U-turn by the US regulator.

The Food and Drug Administration (FDA), said the 23andMe product would "provide people with information about possible mutations in their genes that could be passed on to their children".

It had previously banned similar tests.

The 23andMe kit screens for Bloom syndrome, an inherited disease that is most common among Ashkenazi Jews.

It can detect whether a healthy person is a carrier of the genetic variant that causes the disorder, and therefore at risk of passing it on to their offspring.

(continues ... )


http://www.bbc.co.uk/news/technology-31552029

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Forbes: http://tinyurl.com/p2tn6an

23andMe blog: http://tinyurl.com/qde5f67

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[Little bit]

A Californian start-up

23andme's been around since 2007/2008. What classifies as a start up? In reference to the crux of the article, it really is a turn-around in thinking from the FDA:

In a statement, the FDA also said it would provide the "least burdensome regulatory path" for future projects from 23andMe and similar companies.

"In many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information," the regulator added.

Why the shift, I wonder?

[miiser]

My sense is that this is really not a shift or turn around by the FDA. It is simply a matter of 23andme now being in compliance with regulatory requirements. Previously, 23andme was advertising a medical service which had not been reviewed and approved by the FDA. 23andme had apparently not followed the required process to gain approval before providing such a service. Since then, the FDA has worked with 23andme to help bring them into compliance with the regulatory process. The issue was not that these DNA tests had been outright banned, but simply that they had not yet been reviewed and approved by the FDA. 23andme was prohibited from offering such products until this situation was remedied.