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23andMe Seeks Collaboration with FDA, NIH on Genetic Testing Guidelines

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Direct-to-consumer genomics firm 23andMe has sent a letter to the heads of the US Food and Drug Administration and National Institutes of Health asking for a collaborative effort to develop guidelines for genetic testing.

The firm posted the letter that it sent to FDA Commissioner Margaret Hamburg and NIH Director Francis Collins on its blog, The Spittoon, last night.

23andMe is one of several companies to be targeted recently by FDA, which sent letters to several firms saying that it believes the firms are selling unapproved diagnostic devices. The other firms that received letters were Knome, 23andMe, Decode Genetics, Navigenics, and Illumina, the last of which was cited for providing the tools that are used to provide genetic information to certain of the DTC genomics' customers.

In the letter sent to FDA and NIH, 23andMe noted that there have been reports of inconsistencies in the results provided by DTC genetic test providers. Specifically, it pointed to a paper published in October 2009 in the journal Nature, in which the authors cited inconsistencies in the results provided by 23andMe and Navigenics.

Though Nature did not publish a joint response from 23andMe and Navigenics to that paper, the firms made it publicly available. In that response, they took exception to some of the methods used, but they also said they agreed with most of the recommendations made by the authors, who were from the J. Craig Venter Institute and the Scripps Translational Science Institute.

"We believe that it is important to emphasize that different genetic testing companies can report inconsistent results even when based on tests with proven analytical validity," 23andMe wrote this week in its letter to FDA and NIH. It added that such inconsistent results may be confusing to physicians and consumers alike.

The firm asked FDA and NIH for help in developing broadly applicable standards and guidelines for providing genetic test results and risk estimates. For example, the firm said such a collaborative effort could develop guidelines for acceptable analytical validity; standards for the positive and negative predictive value of tests; and best practices for companies that could lead to results being readily compared across companies.

"We note that any framework developed for genetic testing companies must consider the multiple high throughput technologies on the horizon, including genome, exome and transcriptome sequencing," it said in the letter. "For this reason, the set of ideas we present above does not include having an organization define a specific set of markers as an acceptable genetic test."

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