Genetic testing kits may not get ready approval from federal regulators as an FDA advisory panel has warned of the danger of misinterpretation of results.
Companies would be discouraged from selling directly to the customers, for the panel has advised that medical professionals should sign their approval either for ordering the tests or for interpreting the results. This definitely restricts the easy availability of the tests or results without validation.
AdvertisementAlthough many genetic tests are only available through doctors who take charge of interpreting the results, there is a growing industry of direct-to-consumer testing companies. Their products may not be as reliable as advertised, the panel feels. George Netto, MD, an associate professor and prostate cancer researcher at the Johns Hopkins University School of Medicine and a member of the panel states, "A lot of us feel that these tests are not going to be safe enough to be in DTC [direct-to-customer]."
On the other hand, companies have warned that aggressive regulation would only result in inhibiting patients in their efforts to improve their health. Mary K. Pendergast, a board member of the drug company AesRx, a lawyer and industry consultant who served for seven years as FDA's deputy commissioner states, "We can't live our lives where we can't know anything until everything is known."
The dilemma FDA faces is how to balance patients' rights to information about their risks for disease with the need to have professionals involved in the interpretation of results. Alberto Guttierez, PhD, director of the FDA's office of in vitro diagnostics, says the FDA would look at tests on a case-by-case basis to decide if they should be available directly to consumers or have doctors monitoring the administration and the interpretation of the test.