Bloomberg BNA – The new genetic tests approved by the FDA can help individuals by identifying a disease risk but they don’t diagnose, executives from disease-focused nonprofits stressed to Bloomberg BNA.
The Food and Drug Administration announced April 7 it has approved for marketing 23andMe‘s Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions, including Alzheimer’s, Parkinson’s and blood clots. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain diseases or conditions, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement, adding that “genetic risk is just one piece of the bigger puzzle.”
Executives for nonprofits dedicated to finding treatments for the 10 diseases were thankful for the risk detection and education opportunities the approvals offer but also were cautious. “Early diagnosis is critical to care planning and engagement in research for people with Alzheimer’s or related dementias, and their caregivers. We must be exploring new technologies like 23andMe, which educate about risk and empower citizen science,”UsAgainstAlzheimer’s co-founder and chairman George Vradenburg told Bloomberg BNA in an April 11 email. “In Alzheimer’s, however, genetics is not destiny. Many of the risk factors for Alzheimer’s are modifiable, so regardless of genetic test results, there are behavioral changes we can make to improve brain health.”
Read more at Bloomberg BNA.