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”.
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.”
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.”