But manufacturers of direct-to-consumer (DTC) genetic tests -- as well as the companies that make the therapeutic interventions that might be used as a result of such tests -- have an opportunity as a result.
By satisfying customer cravings for guidance about when and how to use DTC genetic tests, manufacturers have the opportunity to establish a distinctive foothold in the marketplace.
And manufacturers need to do this before it is done for them in ways they might not want.
The Food and Drug Administration's (FDA) review of how to handle DTC test kits became more urgent in 2010 when Pathway Genomics announced an agreement with Walgreen Co to distribute the tests through its 6,000 neighborhood pharmacies.
Walgreen's suspended plans to sell Pathway's tests to consumers after an FDA warning that the test is not approved and could put consumers at risk, but the FDA is asking experts about:
- The wisdom and practicality of sorting tests into categories, such as those that look for inherited disease vs. predict a risk of future disease vs. predict the chances of responding to particular drugs.
- The need for professional genetic counseling to interpret test results correctly.
All customer constituencies are -- or should be -- hungry for valid, evidence-based guidance about (1) whether, when, and how to use DTC and physician-ordered genetic testing and
(2) when paying for it is a sensible healthcare investment.
The complexity of the relationship between DNA results, disease risk, treatment availability, and the value of knowing one's risks challenges even the most sophisticated experts. The task of arming consumers with even the most basic understanding of the utility -- or lack of utility -- of DTC genetic testing is daunting, and the area is just as fraught for regulators, physicians, and payors.
An Object Lesson for DTC Testing: Cholesterol Home Test Kits
Despite almost two decades of consumer education, and treatment and testing innovation, a 2003 Consumer Reports article maintained that cholesterol test kits didn't provide enough information to be helpful.
The array of genetic tests that will be directly available to consumers is going to increase very quickly, and those tests will tell us about things far more important -- and scary -- than bad cholesterol. While the opportunity to help patients and physicians more effectively manage health and illness is vast, so too are the risks of needless anxiety, misspent funds, and medicolegal liability.