By Julie Steenhuysen
CHICAGO (Reuters) - Just as 23andMe has made peace with the US Food and Drug Administration, another direct-to-consumer genetics company is testing the regulatory waters with the launch of a $249 DNA test designed to predict drug response.
The test, from tiny startup DNA4Life based in Mandeville, Louisiana, comes in the wake of 23andMe's two-year tussle with the FDA over its direct-to-consumer personal DNA testing service, which the FDA ordered off the market in 2013.
Last month, 23andMe relaunched its service with a limited number of genetic tests for carrier screening - tests that show whether an individual carries genes associated with 36 different disorders that could be passed on to a child.
But the agency has yet to approve direct-to-consumer tests for pharmacogenetics, a field experts believe could be much riskier in the hands of consumers, who might use the information to make decisions about the drugs they are taking.
Richard Zimmer, chief executive of DNA4Life, said he has been watching developments at the FDA closely and said his regulatory advisers believe the test does not need FDA approval.
Zimmer said tests such as his are regulated as lab-developed tests under guidelines established by the Clinical Laboratory Improvement Amendments or CLIA, which do not require companies to prove clinical validity or usefulness in aiding patient care.
In response to a query by Reuters, FDA spokesman Eric Pahon said the agency "actively regulates genetic tests sold directly to consumers, including pharmacogenetics tests, to make sure they are safe and do what they claim to do."
"Without FDA oversight, the safety and efficacy of the tests have not been determined and could potentially lead to patient harm," Pahon said.
When told of FDA's stance, Zimmer said, "We would be delighted to have a conversation with the FDA," but added that it is not under the agency's purview. "Of course, the government can do what it likes."
Currently, pharmacogenetics tests are ordered directly by a treating physician and are not available to consumers. One, GeneSight, made by Assurex Health, is covered by Medicare and some insurers. Out of pocket, GeneSight costs more than $3,000.
To get DNA4Life's $249 test and report, consumers must agree to share their results with their doctor and answer a few screening questions. A network of DNA4Life doctors uses those answers to determine whether to order the test, which assesses 12 common genes affecting drug metabolism and response.
It is a setup similar to one used by Pathway Genomics, which in September launched a DNA cancer screening test for healthy people. They, too, offered online screening tests and physician ordering. Just a few weeks after the launch, FDA sent Pathway a warning letter expressing concern that test could harm public health.
For Zimmer, the push is personal, born out of the experiences of his 16-year-old daughter, who suffered with severe depression while her doctor tried to find the right medication and dose to treat her. Zimmer believes consumers should have access to their own data through an affordable test.
Dr. Keith Stewart of Mayo Clinic's Center for Individualized Medicine said there are no direct-to-consumer pharmacogenetic tests and "at this point, FDA approval is likely to be required."
Stewart said studies showing the tests are clinically valuable are "few and far between," and those that have been done have been sponsored by the testing companies.
The problem, said pharmacogenetics expert Dr. Josh Peterson of Vanderbilt University, is that patients, and even doctors, struggle to understand what to do with the results.
"I think that is one of the FDA's concerns," he said. "I'm an internist. That would be one of my concerns as well."
(Reporting by Julie Steenhuysen; Editing by Andrew Hay)