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ADVANCE Discourse: Lab

Genetics and Litigation

Published December 11, 2013 1:16 PM by Michael Jones

In recent months, there has been a lot of litigation and government influence regarding companies offering genetic sequencing services. Following the memorable SCOTUS ruling against Myriad Genetics in June and the company’s subsequent law suit involving Ambry Genetics, the FDA joined in on further regulatory disputes with a cease-and-desist letter to 23andMe in November. A Dark Daily news briefing detailed the specifics of the FDA letter as well as backlash from costumers against 23andME.

According to the briefing, 23andMe received a letter from the FDA about a saliva test being marketed by the company, which claimed to work in a preventative capacity. The letter specified that the company should cease all marketing of the product and respond within 15 days, as the product would be used in a diagnostic capacity and would subsequently require FDA clearance. 23andMe complied and is currently in communication with the FDA.

On top of problems with the FDA, a class action law suit has also been filed against the company by Lisa Casey. According to the Dark Daily piece, Casey voiced concerns about the validity of the test, calling the results “meaningless.” Additionally, the story noted the company’s “hopes to pool the information from millions of customers to eventually create databases that can be mined for medical research.”

“It seems to me to be a very thinly disguised way of getting people to pay them to build a DNA database,” said Mark Ankcorn, a San Diego-based attorney who filed in the class action suit on behalf of Casey, in the Dark Daily release. He continued, “I anticipate they are going to fight it and use every available resource they have to deny the claims.”

The news briefing discussed the concept of putting together a genetic database and the impact it could have both on the company putting it together as well as the industry as a whole. With an accessible database, 23andMe could potentially see financial benefits from patenting based on information obtained from their records for example. The news briefing also pointed out that clinical laboratories and pathologists could also benefits from an overall database of genetic information. 


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