News of the California Health Department’s mailing of cease and desist letters to 13 direct-to-consumer genetic testing firms, such as 23andMe, Navigenics and DeCodeMe, has sparked intense debate over balancing regulations to guarantee quality and individual rights to genetic data.
Here on THCB, Matthew Holt called the move the "first establishment challenge of Health 2.0."
"This is a case where the regulations are running way behind the technology, and the trade protection organizations of health care providers are, I’m sure, whispering in the ear of the regulators," Holt wrote.
Why all the fuss now?
CA regulators say doctors must be involved in ordering and deciphering the genetic tests, which currently are offered directly to consumers. Currently, customers pay about
$2,500 at Navigenics for an initial one-year membership — and then an
annual fee of $250.
23andMe and DecodeMe both charge about $1,000 for permanent access.




