FDA Approval

This October, DNA testing company 23andMe was granted FDA approval for offering health reports to consumers that lets them see how their bodies process medication.

According to Business Insider, the new tests identify which genes are involved in breaking down heart medication and antidepressants, for example. These types of tests normally require psychiatrists and doctors to get involved, though they can be purchased via genetics-testing kits and pharmacies like Albertsons. These tests can run from $250 to upwards of $750 normally, but with 23andMe results are cheaper and don’t require a doctor to obtain.

A health and ancestry report for 23andMe currently costs $199.

23andMe began selling DNA testing kits to provide information on customers’ ethnic heritage (now with over 150 regions defined), but to differentiate itself in the competitive market, they began offering health reports, too. Their current gene-testing kits include screenings for genes involved with Alzheimer’s, Parkinson’s Disease, and breast cancer. Now, the new FDA-approved reports on medication will be available for purchase.

Earlier this year, pharmaceutical giant GlaxoSmithKline acquired a $300 million stake in 23andMe, which might contribute to the company’s focus on researching DNA for health matters.

23andMe is the first genetic testing company to be granted FDA approval. However, the federal agency was also quick to point out that consumers should avoid purchasing similar tests that haven’t been approved, noting the science could be dubious. Other DNA testing companies that offer medication-related health tests require the involvement of a physician or psychiatrist.

The FDA did provide some restrictions regarding the new reports, saying they were “not intended to provide information on the patient’s ability to respond to any specific medication” according to a statement. They also advised that patients should check with their doctors before stopping any medication.

The approval has caused some controversy in the scientific community. Many scientists feel the tests are not reliable and not worth the money according to Business Insider, because the tests may give conflicting results to the same patient for the same medication. Plus, the FDA’s warning underscores the fact that the 23andMe reports are somewhat meaningless because they don’t provide information on which medication is best for a particular patient.

Scientists have warned about 23andMe reports before, despite the company receiving FDA approval last year for additional health reports, including the test for some genes that indicate whether you are at risk of getting breast cancer. This was especially concerning to the scientific community, because the reports did not explain that the test was limited to only a small number of gene variants, and the company did not provide genetics counselors to thoroughly explain potential genetic risks to customers.

23andMe however sees the reports as an added bonus to customers who are already getting DNA-tested, and that it might help people better manage their health and be more informed.