By Dr Ananya Mandal, MD
According to an advisory panel to the U.S. Food and Drug Administration, genetic tests sold directly to consumers that might help to predict health risks may need to be supplied through doctors. An official, Alberto Gutierrez, director of the FDA office that regulates diagnostic screening tools reported that the Molecular and Clinical Genetics Advisory Panel concluded two days of hearings on the increasingly popular tests and had come to this resolution.
Gutierrez added, “We’re probably not going to be able to take one approach to all the types of tests that the companies want to offer… It depends on the disease and the type of test.” The FDA may require that some genetic tests be ordered by doctors, and some test results may have to be sent to doctors instead of patients, he said. Other tests “may not require a doctor at all,” he said. In the hearing the panel only those genetic tests sold directly to consumers without the involvement of medical professionals. The kits enable people to have their genetic material analyzed to identify variations that might be related to inherited disorders, such as cystic fibrosis, breast cancer and even Alzheimer’s disease.
These tests have come up as a result of the U.S. Human Genome Project, begun in 1990, which boosted understanding of human health, disease and genetics, the FDA explained in a background summary. Because the field is so new, little is known about the accuracy of home genetic tests or the implications of test results, particularly if a health-care professional is not involved to help consumers interpret the results. Pathway Genomics had announced last year that it would sell tests costing from $400 to $2,000 at Walgreens stores, which are ubiquitous in the United States. Walgreens reversed its decision, however, after the FDA raised questions about the supplier.
The FDA urges test manufacturers for input in a variety of areas, including the reliability of the tests, the possibilities for misuse, the likelihood and consequences of misunderstood results, and how a lack of counseling might affect people who receive disturbing results. Manufacturers have defended their approach to the tests but test accuracy is a key concern of skeptical medical professionals. A recent undercover study of 15 direct-to-consumer genetic tests by the U.S. Government Accountability Office found “egregious examples of deceptive marketing, in addition to poor or non-existent advice from supposed consultation experts,” according to a report published in The Lancet. For the GAO investigation, investigators purchased 10 tests each from four different direct-to-consumer genetic testing companies - 23andMe, deCode Genetics, Pathway Genomics, and Navigenics - and the interpretation of the results differed according to which company analyzed the results.