California: New Regs for Gene Tests?
From the San Jose Mercury News: Online gene testers propose their own regulations
After gene-testing businesses were criticized by state regulators last year for marketing to California residents without a license to perform clinical laboratory tests, the industry decided it was time for new regulations — which it decided to write.
A bill drafted by 23andMe and introduced by state Sen. Alex Padilla, D-Van Nuys, would exempt gene-testing firms from requirements faced by other kinds of labs while adding new privacy protections for consumers....
The bill amends the California Business and Professions Code to distinguish conventional lab services from "bioinformatics services," which use mathematical algorithms to identify ancestry and disease risk. That's appropriate, the companies say, because they don't actually perform the scans themselves — they are simply Web portals that disclose the results of tests performed by contract labs, which are licensed.
This sounds suspiciously like an attempt to fragment moral responsibility.
Additionally, SB 482 would not require physicians but rather experts with either a master's or a doctorate to approve the mathematical algorithms used to interpret genomic data. The tests are not diagnostic but merely educational, the companies say.
"Merely educational," eh? They why do company websites refer to things like "taking control of your health," etc.? And, company websites aside, given the buzz about genetic testing, how many customers are going to make the reasonable assumption that a genetic test must have some diagnostic significance?