California ok with SNP chip testing with MDs

In the New York Times today it appears, California has been satisfied by 2 of the big 3 DTC SNP Chip testing companies. From the article:

Two closely watched companies that offer consumers information about their genes have received licenses that will allow them to continue to do business in California, a state official said Tuesday.

The licenses, granted to Navigenics and 23andMe, should help defuse a controversy that began in June when the California Department of Public Health sent “cease and desist” letters to the two companies and 11 others that offer genetic testing directly to consumers.

I don't think Andrew spoke to the geneticists I work with. I don't think a state license will ever defuse this powder-keg. But I do congratulate both companies on working within the state regulatory system. I appreciate their efforts. It really casts a great light on the non-academic genetics services and testing services.

The companies had argued that they were not offering medical testing but rather personal genetic information services, and that consumers had a right to information from their own DNA. The companies also said they did not need a license because the actual testing of the DNA samples was being done by outside laboratories that did have licenses.

Looks like they needed the licenses after all. This argument was a fallacy. As a practitioner I could say I don't need a license to practice medicine to interpret Liver Function Tests, because I send all of my samples to Quest. Huh??? Exactly.

Ms. Billingsley said the companies also satisfied the requirement for a doctor to be involved. Navigenics already was paying a physician to review customer orders and now it appears that 23andMe might be doing something similar.

This was a needed step. Not only for the State, but also federally as the AMA and ACMG have mandates that will be heavily represented in either possible administration.

New York State also has taken action against at least 31 genetic testing companies, saying they cannot solicit business from New York residents.
Ms. Baker of Navigenics said a resolution with New York did not seem imminent.

I am doubtful New York will even budge on this. They are very stringent with their requirements. Very Stringent.

“We do think in the end this needs to be regulated at the federal level rather than as a patchwork of state regulations,” she said.

What would that regulation look like? We have 2 possibilities.

1. S. 736, the Laboratory Test Improvement Act, sponsored by Edward Kennedy (D-MA), chairman of the Health, Education, Labor & Pensions (HELP) Committee, with ranking Republican Gordon Smith (OR) as co-sponsor, and

2. S. 976, the Genomics & Personalized Medicine Act, sponsored by Barack Obama (D-IL), with co-sponsor Richard Burr (R-NC), both members of the HELP Committee

The breakdown?

While acknowledging that it is important not to stifle innovations or impede patient access, both Kennedy and Obama say federal oversight is needed to assure the analytical and clinical validity of genetic testing and to monitor direct-to-consumer marketing that makes questionable medical claims for unapproved test kits.

Under the Obama bill, S. 976, Congress would solicit outside expert advice before further regulation of genetic testing and genomics. The HHS Secretary is to contract with the Institute of Medicine to study and make recommendations on the key issues. Once the report is submitted, the Secretary is to develop and propose a decision matrix to help labs and other test makers know which types of tests require which level of review and who is responsible for the review––CMS or the FDA, or both. The bill also requests a study by the National Academies of Sciences on incentives to stimulate advances in designing and developing new genetic testing technologies.

The Sherpa Says:

Either way....when you ask for federal regulation.....you should be very careful of what you wish for......