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California state Senator Alex Padilla (D-San Fernando Valley) recently introduced SB 482, a bill to amend the California Business and Professions Code to address entities providing personal genome services. As amended on April 14, the bill would define a new category of business, one that provides “post-CLIA bioinformatics services,” and exempt such businesses from requirements applicable to traditional clinical laboratory service providers. The bill also would specify the requirements under which such entities can operate within California.
The bill is sponsored by the California-based personal genome services provider 23andMe. It follows actions last year by the California Department of Public Health (CDPH), which sent letters to 12 businesses offering direct-to-consumer (DTC) genetic testing, including 23andMe, ordering them to stop selling tests in the state until they demonstrated compliance with state and federal regulations. The relevant federal law is the Clinical Laboratory Improvement Amendments (CLIA), whose requirements are implemented and enforced by the states. The CDPH letters stated that the companies must have a California license and a CLIA certificate to operate, may not provide tests without a physician order, and...
The bill is sponsored by the California-based personal genome services provider 23andMe. It follows actions last year by the California Department of Public Health (CDPH), which sent letters to 12 businesses offering direct-to-consumer (DTC) genetic testing, including 23andMe, ordering them to stop selling tests in the state until they demonstrated compliance with state and federal regulations. The relevant federal law is the Clinical Laboratory Improvement Amendments (CLIA), whose requirements are implemented and enforced by the states. The CDPH letters stated that the companies must have a California license and a CLIA certificate to operate, may not provide tests without a physician order, and...