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FDA Warns More DTC Genetics Firms

This article has been updated with comments from PQDNA CEO Andre Gous.

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has notified three more companies marketing genetic tests directly to consumers that their tests make medical claims, appear to qualify as medical devices, and should be regulated.

The firms that received letters include Lumigenix, American International Biotechnology Services (AIBiotech), and Precision Quality DNA (PQDNA).

The letters from FDA's Office of In Vitro Diagnostic Device Evaluation and Deputy Director of Patient Safety and Product Quality James Woods urges the three firms to set up meetings with FDA to discuss whether they are required to obtain FDA clearance or approval for their tests.

Lumigenix offers the Comprehensive Kit, a testing service aimed at providing individual genetic predisposition for 79 disease conditions.

The AIBiotech Sports X Factor Test Kit is intended to provide athletes and parents of young athletes information about how to maximize physical workouts and to inform training. But the company also makes medical claims about the tests, such as identifying the length of time an athlete needs to rest after experiencing a concussion and risk of developing undiagnosed heart condition.

PQDNA markets a service that provides guidance about how to understand genetic data in search of relevant information, including SNPs, deletions, and mutations that could lead to specific conditions, including for BRCA1/BRCA2 status and likely response to drug treatments.

A spokesperson representing AIBiotech told GenomeWeb Daily News in an e-mail that it has responded to FDA and has scheduled a meeting for later this week.

In the letters, dated May 11, FDA said it wishes to meet the companies within 15 days to "to discuss whether the test you are promoting requires review by FDA and what information you would need to submit in order for your product to be legally marketed."

FDA began sending such warning letters to DTC genomic testing companies in June 2010, when it notified a number of companies, including Knome, 23andMe, Decode Genetics, and Navigenics, that their services may need to be regulated as devices under section 201(h) of the Federal Food Drug and Cosmetic Act.

In March, FDA held a panel meeting and heard public comments on potential approaches to DTC testing, including the recommendations that DTC testing should have little or no regulation, that controls on the marketing and availability of such tests should be strict, and that there could be a stratified regulatory approach based on risk.

At the meeting, a wide range of groups and businesses discussed the potential for regulation in this area, and some argued that people should have the right to access to their genomes and that too much regulation could thwart a new and innovative industry. Others have suggested that DTC genomics companies make claims that go beyond the capacities of the current testing science, that they lack real evidence of utility, that their results are inconclusive and subject to interpretation, and that they should be restricted to physician discretion.

PQDNA CEO Andre Gous told GenomeWeb Daily News in an e-mail that if FDA interprets the Food, Drug, and Cosmetic Act to apply broadly to the DTC genomics industry, and regulates the industry as providing medical devices, they could "regulate the industry into de facto oblivion, one DTC company at a time."

"It makes no sense to consider DNA 'spit tubes' as 'medical devices' and thus leverage for inclusion under the 1976 law," Gous wrote in a letter he submitted to the FDA and to members of Congress in April.

"The FDA is attempting to unilaterally expand its involvement into this vital, delicate, innovative industry that is so perfect for a US-based workforce, even if this expansion would be immensely destructive," he stated in the letter.

Gous believes that the DTC industry has taken the view that FDA regulation of the industry is a given, and have put their efforts into making the regulations more manageable and "appeasing the FDA."

He told GWDN that PQDNA intends to take a "fundamentally different" approach, and it will make the case that FDA is considering overextending its reach under the law, potentially squelching free market activities, and that his firm's service is unique and not covered anyway.

The firm's business model represents a new area within the growing DTC field, as its service is aimed at finding out about an individual's health concerns, helping the customer get relevant genetic data, and helping them to make educated choices based on that information, according to its website.

Gous pointed out that PQDNA's service does not provide any form of genetic counseling or family tree analysis. It also does not acquire the data, but expects that its clients will receive their sequence data from a third party, and it does not interpret the data.

"We don't send out spit tubes to collect any samples. We don't have a lab. We own no DNA equipment," Gous told GWDN, explaining that the company intends to make these points clear to FDA in direct meetings.

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