FDA DNA-Test Clearance Opens Genome Floodgates

For the first time in history, the U.S. Food and Drug Administration (FDA) has granted approval for direct-to-consumer (DTC) tests to be sold directly to consumers. Specifically, the FDA has authorized Silicon Valley-based genetic testing firm 23AndMe to market their Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions namely: Alpha-1 antitypsin deficiency, Celiac disease, factor XI deficiency, Gaucher disease type 1, G6PD, Parkinson’s disease, early-onset primary dystonia, late-onset Alzheimer’s, hereditary hemochromatosis and hereditary thrombophilia.

To arrive at their decision, the FDA said they reviewed studies that showed how the procedures used by 23AndMe were able to ‘correctly and consistently’ identify gene variants associated with the 10 conditions. They also looked into other peer-reviewed references that confirmed the links and therefore provided further support to backup 23AndMe’s data.

After being granted FDA approval on April 6, the company says the tests will be available to the public in April.

In anticipation of the debates and discussions that the FDA’s decision might evoke, the agency made it clear that the disease risk tests are simply meant to provide genetic risk information but no more than that. This means that since there are several other factors that can raise or reduce a person’s chances of becoming sick — like lifestyle, diet and a person’s environment — the tests can only provide information on one’s predisposition to develop a condition. Basically, the suggestion here is that the tests cannot be used to determine a person’s overall health risks.

The information obtained from the DTC tests, however, can be used by individuals to reassess and possibly do some lifestyle adjustments, or maybe initiate consultations with a medical professional, especially if the information received is unfavorable.

Just imagine, through these $199.00 DTC tests, a person only has to do a simple saliva swab, send it to 23AndMe, then wait for around 6 – 8 weeks for an email from the company that will pretty much let him/her know if he/she has gene mutations that make him/her more susceptible to developing certain diseases.

Even in clinics and hospitals, lab test results cannot be taken at face value. There’s always a need for doctors to correlate the findings with their clinical assessment of the patient in order to come up with the correct diagnosis or a reasonable prognosis.

Interpretation of genetic information remains relatively difficult because the link between specific genes and certain medical conditions isn’t always in black and white. If doctors find it difficult at times that they have to consult other experts to make an accurate assessment, what can be expected from people who have no medical background?

In the case of these DTC tests, if a person receives bad news about his/her disease risk, it might cause unnecessary stress and anxiety because the person will rely solely on that information, without the guidance of a medical practitioner who can put things in perspective.

Back in 2013, the FDA refused to authorize the DTC tests, citing a false positive result could lead to unnecessary treatments. Four years later, however, the tests were made possible via a new permit type from the FDA, including what the agency called “special controls” to assure the accuracy of tests.

Whether or not the public can handle the genetic data info properly remains to be seen. But for those who can, this may indeed prove helpful in the long run, especially if it manages to make people shift to healthier lifestyle choices because of the test results.

As 23andMe CEO and co-founder Anne Wojcicki said in a statement: “This is an important moment for people who want to know their genetic health risks and be more proactive about their health. The FDA has embraced innovation and has empowered individuals by authorizing direct access to this information.”

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