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They're Baaaaaack!

February 09, 2011

Once again, FDA is meeting to discuss direct-to-consumer genetic tests, reports Genomics Law Report's Dan Vorhaus. In one month, the regulatory body's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will hold a public meeting to discuss the scientific issues surrounding DTC tests that make medical claims, Vorhaus says. The panel will investigate the risks and benefits of making such tests available to the public without a prescription, the different types of tests and how they could all be regulated, and the type of science that should be required to back up these tests' claims. "The meeting is a tacit acknowledgment by the FDA that the agency needs to continue to gather data and viewpoints about DTC genetic tests, along with the unique opportunities and challenges they present, separately from its ongoing efforts at LDT regulation," Vorhaus says. The public can submit comments to FDA until February 23, and can apply to make an oral presentation at the meeting until February 15.


Genetic Tests that help a

Submitted by nunesdale on Wed, 02/09/2011 - 18:24.

Genetic Tests that help a individual be proactive about their health in order to achieve optimal health, feel better, slow the aging process, or to prevent disease from developing in the first place, should not require a prescription. Regulations should protect against false claims and require full disclosure of the science backing up the tests. A prescription takes the decision away from the indiviual that wants to know more about their own DNA and gives it to some one else. A prescription for tests to treat the symptoms of a disease or eliminate the disease for people that have contracted an illness should be required. Genomic's offer's valuable information for a Personalized Health Program and a new focus on prevention. It will be key to lowering health costs.

@nunesdale: You cannot speak

Submitted by david.m.jackson.phd on Sat, 02/12/2011 - 17:45.

@nunesdale:

You cannot speak out of both sides of your mouth on this issue. Either you make decisions from the data provided by a test or you don't. If you make a change, it's a diagnostic test. Note that even if you can do nothing with the information, then it is still a test, just a useless one.

However, you present a second mistake - you make the unsubstantiated claim that the results of DTC correlation test can: "help a individual be proactive about their health in order to achieve optimal health, feel better, slow the aging process, or to prevent disease from developing in the first place" and "Genomic's offer's valuable information for a Personalized Health Program and a new focus on prevention." and even the audacious "It will be key to lowering health costs."

Read your words carefully then either provide specific scientific evidence of your claims or admit that no such evidence exists (I'll save you some time - there is no such evidence).

This is the fundamental problem with DTC testing. There is no body of evidence accumulated with large cohorts of patients under properly design protocols to show that the information has value in the form of pointing at lifestyle changes that if made will have disease prevention and/or longevity benefits. Contending that a 25% increased risk of developing disease X is hardly evidence of anything other than increased risk and even that is subject to significant scrutiny and skepticism.

It is good that FDA wants to regulate these tests. It is ironic that FDA also allows the sale of homeopathic "medicine" and "nutriceuticals" but apparently the psuedoscience of DTC testing matters to them.