(AP) – 7 hours ago
WASHINGTON — The Food and Drug Administration is issuing regulatory letters to five genetic test makers, the first sign that the government is cracking down on companies that claim to use DNA samples to predict inheritable diseases.
The FDA letters notify each company that their tests are considered medical devices and therefore must be federally approved as safe and effective. None of the companies have submitted their products for approval, according to the FDA.
The letters posted online deal with specific tests marketed by: 23andMe Inc., deCODE Genetics, Illumina, Navigenics and Knome Inc.
FDA asks each of the companies to contact the agency to make arrangements for submitting their tests for review.
Copyright © 2010 The Associated Press. All rights reserved.
Fresh off sending stern letters to five consumer-genomics companies indicating that, as currently marketed, the companies’ tests will require clearance by the FDA, Alberto Gutierrez—the agency’s director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health—spoke to NEWSWEEK. Among the revelations: Pathway Genomics, the company that started the controversy by planning to sell its test in drugstores, will be withdrawing from the direct-to-consumer market. Gutierrez also clarified the agency’s reasoning and timing. Excerpts:
Just to clarify, it sounds like these consumer-genomics tests—as they’re marketed now—will require pre-market clearance because they qualify as medical devices under current law. Is that correct?
FDA: That’s correct.
Why is this happening now instead of three years ago, when direct-to-consumer genomics tests first came to market?
FDA: Well, the claims [made by the companies] have changed constantly. The original claims from three years ago were very, very vague. For example, the claims they’re making now for the different drugs and how they’re metabolized, those weren’t being made previously. Even some of the health claims in terms of risk of chronic disease, those just started coming online about a year ago.
So the problem is that the companies are testing for genetic variants that might affect the way consumers make medical decisions?
FDA: That’s correct … If you’re making a claim about [a genetic variant that affects the metabolism of the anticoagulant drug] warfarin, and somebody decides based on the result they get that they want to change their dosing, that is a fairly risky decision. That could affect their health. If they’re not feeling well on their current dose and the drug is expensive, we don’t know what they would do.
Illumina and Knome are different from the other three companies, but they were also sent letters. Can you explain to me the thinking behind the letters to each of them?
FDA: Well, some of the other companies are buying the chip that Illumina is making. That chip is sold as for “research use only.” As such, Illumina has a responsibility. If the chip is being used for diagnostic tests instead, Illumina has to follow the law, and they are aware that the chips are not being used for research only.
Would Illumina still have to obtain pre-market clearance if it sold that chip to medical laboratories and doctors only?
FDA: Yes, if Illumina is selling their chips to clinical labs that are using those chips to provide results back to either physicians or patients, and if they know that is how the chips are being used. However, they could [sell the chips without pre-market clearance] to academic labs or clinical laboratories which are clearly in the research space—meaning they’re beginning to develop a new test and just looking what they can do with it. That’s different than providing clinical results to patients.
What Knome sells is more of a service than a device. It’s basically a software program that explains genetic data that consumers can have generated elsewhere. Can you explain to me why it requires pre-market clearance?
FDA: Software is a medical device, and they’re making medical claims. They’re taking results and making medical claims that come out of those results.
What about other companies that sell their tests to doctors, rather than directly to consumers, such as Counsyl?
FDA: Counsyl actually used to be a direct-to-consumer company until we sent Pathway the “it has come to our attention” letter. Then they changed their business model. They’re going through clinics or doctors. In that case, it will depend on whether they fit under the model of a laboratory-developed test. If they don’t, they will have to come in and get their test cleared.
While reading this I couldn't help but thinking that somebody picked the right time to get OUT of the machine business! D'oh!
I don't like the "software is a medical device" bit though. Maaaaaaybe, but that's as gray of an area as it gets and could give the Food and Death Administration even more powers it doesn't know how to properly wield.
Bigger and bigger government is double-plus-ungood.
thanks for the dd...appreciate your effort. Again, all I can think of is Stan Lapidus's presentation in December 2009 in which he states Helicos have first off the mark advantage in getting FDA platform approval and reaffirmed this would be the make or break for diagnostics companies going forward.....since then we have got government endorsment via NIH grant...we have refocussed into a diagnostics company...we didnt get the FDA letter....it's only joining the dots to say that we may soon get another type of letter from the FDA..an appoval letter. Any guess on the pps if this happens?
"The letters clearly indicate that the FDA has its eye on both measurements of genetic test quality, as it should. More significantly, the letters appear to indicate that the agency considers the products in question to provide “clinical interpretations” and/or to be used in “healthcare decisions.” In the long-running debate over whether DTC genetic testing qualifies as clinical medicine, it appears that the FDA may have come down on the clinical side of the fence, at least for these particular products."
Concern about the tests was also raised this week when 23andMe said that because of a laboratory mix-up, up to 96 customers might have received genetic information belonging to someone else.
Daniel Vorhaus, a lawyer specializing in regulation of genetic testing and author of the blog Genomics Law Report, said some of his clients were holding back introducing tests because it was unclear which would require regulation.
“No one has a clear understanding of where the F.D.A. is drawing the line at this point,” said Mr. Vorhaus, who does not represent any of the five companies that received the letters. He said the F.D.A. was “trying to keep up with a commercial space that is moving way faster than they are capable of.”