On June 25, Peter Kazon’s insight was featured prominently in two articles appearing in Pharmacogenomics Reporter, both dealing with the issue of direct-to-consumer genetic-testing companies and recent actions being taken against them by the state of California. One key issue, according to Mr. Kazon, is whether such entities need to be licensed by state departments of health, even when they outsource their lab work to licensed laboratories.
In “In California, Outsourcing Genotyping Services to Licensed Lab May Not Equal Compliance,” Kazon offered that, whether these direct-to-consumer genomics firms are actually doing their own testing or not, “from the state’s perspective, may not make much difference.” Establishing the necessary clinical and analytical validation requirements may be the murkiest part for these sorts of companies: “Th[is] is a really new issue, and one that has not been greatly discussed or considered by regulators.”
In “Is Internet’s Ability to Dilute Regulatory Efforts Feeding DTC Genetic-Testing Row?” the discussion turns to the role the internet plays in making the murkier parts of the issue even murkier. State health regulators, according to Kazon, “take the view that any analysis of a specimen from a person’s body is a laboratory test—even if it’s just a swab from the inside of a person’s cheek—and the companies that offer services analyzing such specimens are, in fact, offering laboratory testing and therefore are subject to the [state] laws regulating laboratories and laboratory testing.” Conversely, “the companies seem to be taking a view that this is really an educational service [and] not really meant to be medical or clinical information.”
Kazon goes on to note that California is “planning to take [this issue] very seriously. If it wishes, the state could go to court and try to prevent the companies from offering services to California residents, though how a company does that in the Internet age is going to be difficult.”