HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Friday, June 20, 2008

Genetic Testing Regulation and Inspection

Earlier this week, California started inspecting genetic testing companies.  The LATimes reported,

California health regulators have dealt a blow to direct-to-consumer genetic testing start-ups by demanding that 13 companies halt sales in the state until they prove they have met quality and reliability standards.

The Department of Public Health sent the cease-and-desist letters last week, after an investigation spurred by consumer complaints about the tests' accuracy and costs, a department spokeswoman said Monday. The department said it would not identify the companies involved until it confirmed they had received the letters. It said they all advertised on the Internet. Two of the best-known companies to offer consumer genetic tests, Navigenics Inc. and 23andMe Inc., both confirmed receiving the letters.

All the companies have two weeks to demonstrate to regulators that their laboratories are certified by the state and federal governments, said department spokeswoman Lea Brooks.
They must also show that the tests currently being sold to California residents have been ordered by a doctor, as required by state law.  Companies face fines of as much as $3,000 a day if they don't comply.  The New York State Department of Health issued similar notices to nearly two dozen testing companies in April. . . .

The Food and Drug Administration does not evaluate the tests for accuracy, though a federal panel recently recommended stepped-up oversight to ensure their validity.

Many individuals have responded to the new genetic testing companies and the required inspections and certifications California requires.  The LATimes has collected some of the results and writes,

. . . .   Should a doctor's authorization be required for someone to obtain personal genetic testing? So far, California and New York state authorities say yes. But this debate is just beginning. The controversy is being played out this week on the many genetic medicine blogs. Daniel at Genetic Future writes:

"To a large extent what's going on here is a turf war between proponents of the old-school medical regulation model and upstart advocates of the free information paradigm of the Google generation."

Jason at TechCrunch suggests the lack of professional medical advice accompanying personal gene testing is troublesome, too:

"The problem with this kind of casual DNA testing is that it almost trivializes the importance of genetic information." . . .

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can anyone answer the question of whether NY State Dept of Health actually requires a physician prescription for a genetic test, or does it require that there either be a physician order, or that the lab which processes the human sample be authorized/licensed by the NY Dept of Health? also, does anyone know if NY Dept of Health considers a genetic testing company a lab itself (and therefore requiring certification) or is it ok if the company just uses/contracts with a certified lab to process its samples?


Posted by: Peter Castellano | Jul 11, 2008 9:30:38 AM

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