Posted by Pharmacogenetics Reporter has a lengthy article (subscription required) on the California bill SB 482, sponsored by personal genomics company 23andMe, which seeks “to distinguish so-called “post-CLIA bioinformatics services” from entities providing laboratory services”.
In other words, 23andMe is pushing to have companies purely providing analysis of genetic data regulated separately from those doing the actual laboratory testing. Since 23andMe out-sources its testing to an external laboratory, this would exempt the company from some regulatory requirements. The move follows some fairly serious regulatory controversy over direct-to-consumer testing in California a year ago.
However, this isn’t simply an attempt to make the situation easier for direct-to-consumer genetic testing companies. The bill also proposes regulations that would raise the bar for genetic testing companies, and hopefully close out some of the shadier operators in the space:
However, SB 482 would also set operating standards for “post-CLIA bioinformatics services” for the first time. If passed, SB 482 would require these companies to use a licensed clinical lab to analyze customer samples and disclose to customers the CLIA status of the laboratories being utilized.
Under the requirements of the bill, such entities would have to employ an individual, with a Master’s degree or a PhD, to approve algorithms used to interpret genomic data. The companies would have to provide CDPH with a “transparent description of the validity of biological data sets and how to perform the algorithm on biological data sets.”Privacy of consumer data is also addressed by the bill, requiring “post-CLIA bioinformatics services” to delete identifiers linked to customers’ biological data and “take all reasonable steps to prevent the release of individually identifiable information without explicit consent from a customer.”
The ACLU has raised some concerns about the wording of the bill:
In its letter to Padilla, the ACLU recommends the bill be revised to require that all genetic materials be destroyed two weeks after communicating the information to the customer; to use more explicit language banning the release of identifiable genomic data without written consent; and to lift the requirement that customers must consent to research on their de-identified data as a condition of using genomic services.
The ACLU also asserts in the letter that “the requirements in [SB 482] are insufficient for ensuring that the tests these companies offer are accurate and reliable.”
It’s clear that personal genomics companies are in for a bumpy ride over the next couple of years as they wrestle with their critics over the future of the industry.
I hope the right balance is ultimately reached here: it’s obviously a bad idea to give any industry carte blanche to make whatever regulations it wants, but over-exuberant regulation of the industry would do lasting harm to innovation in the development of personalised medicine. The trick will be to find the point at which the bottom-feeders in the industry are punished without holding back companies that are doing things the right way.
June 25, 2009
June 25, 2009
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