The FDA has been stewing for many months about genomic/genetic testing companies with a direct-to-consumer orientation. The agency seems to be particularly exercised about the availability of such testing on the web. Recent articles document its most recent decision, declaring such testing to be a "medical device" (see: F.D.A. Faults Companies on Unapproved Genetic Tests; FDA to monitor genetic testing). Below is an excerpt from from the first of these articles:
The Food and Drug Administration is cracking down on 23andMe and other companies that sell genetic tests directly to consumers. The F.D.A. sent letters this week to five companies involved in that business, saying their tests are medical devices that must receive regulatory approval before they can be marketed....The letters...say the companies must apply for approval or discuss with the agency why certain test claims do not require such approval. But the letters stop short of saying the tests must be taken off the market until they are approved. Dr. Gutierrez said in an interview that it would be unfair to remove the tests from the market because the agency had not clearly told the companies that the devices needed approval. 23andMe and two other recipients of the letters, Navigenics and DeCode Genetics, sell tests that scan a person’s DNA, looking at genetic variations that can suggest whether a person is at a higher or lower risk of getting diseases like cancer or diabetes....Illumina, which also received a letter, sells so-called DNA chips that are used by some companies to do the DNA scans. The fifth recipient, Knome, offers consumers a complete sequence of their DNA, which can be used to glean disease risk information....On one side [of the debate] are some doctors, geneticists and state regulators who say the tests should be regulated because the results might be used to make medical decisions. Some also say a doctor should be involved in ordering the tests and interpreting results. On the other side are those, especially 23andMe executives, who argue that the services merely provide information, not medical diagnosis, and that consumers have a right to the information contained in their genes....The companies have also said that their tests do not require F.D.A. approval because they have been developed and are offered by a single laboratory. The F.D.A. has typically refrained from regulating such tests, as opposed to test kits that are widely sold to laboratories, hospitals and doctor’s offices. The F.D.A. is now clearly deciding in favor of regulation, saying the tests of disease risk can have medical consequences.
Genetic/genomic testing companies, particularly those with web sites, have been constantly in the news but actually have had difficulty attracting a paying audience (see: Web-Based Genomic Testing Sites Fail to Attract Large Paying Audience). The recent letter from the FDA to five companies suggests an escalation of the fight. Of particular interest is that one of the companies receiving a letter, Illumina, manufactures the DNA sequencing chips and a second, Knome, offers consumers a complete sequence of their DNA. This suggests a new and broader reach on the part of the FDA. This goes beyond the agency's initial focus on regulating companies that report a genetic predisposition to diseases like 23andMe.
One of the arguments cited by 23andMe in their defense is that they are "merely providing information" and not specific diagnoses. This strikes me as an artful dodge. I am also not sure if they can find long-term refuge in their "home brew" defense, which means that their test results are generated in a single laboratory rather than from a test kit. The fact that the FDA sent a letter to Illumina suggests that the agency means to tie up this loose end and begin to reel-in the chip manufacturers.
The cost of acquiring knowledge about the complete sequence of one's DNA has become affordable and will become increasingly so in the near future. Although such information does have medical diagnostic and prognostic value, it can be used for other purposes such as genealogical inquiries or gaining an understanding of one's physical characteristics such as eye color or baldness. I think that companies that offer complete DNA sequencing should be required to prove that their test results are accurate but I don't view these services necessarily as constituting a "medical device."
However, when companies doing business on the web begin to report total or partial DNA sequences accompanied by references to the likelihood of developing diseases, however unlikely, they seem to be in the medical diagnosis/prognosis business. Consumers need to be protected in some way because of the potential harm of such claims. I personally do not believe that physicians must be involved as intermediaries in these transactions, which is analogous to my ideas about direct access testing (DAT). Obviously, physicians should be involved when consumers seek advice about how to treat actual or potential diseases.
Comments