Health Care

FDA Approves First Home Test For Breast Cancer Risk

FDA Approves First Home Test For Breast Cancer Risk

What it does: The test, which will be available through 23andMe's $199 health and ancestry service, reports three genetic variants found on the BRCA1 and BRCA2 genes that are most common in people of Ashkenazi Jewish descent.

Things changed in a big way in 2017 when the FDA authorized 23andMe to provide direct-to-consumer DNA testing for 10 conditions like celiac disease, Parkinson's, Alzheimer's, and more. Most breast cancer mutations that increase a person's risk are not detected by this test. "But it has a lot of caveats", said Donald St. Pierre, acting director, Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. Any person who comes back with a negative for these three gene mutations, for example, could still carry other mutations in the BRCA genes that elevate their cancer risk. (These three are also not the most common BRCA mutations.) The testing done in professional medical labs is more detailed, and can definitively find more of genetic risk factors. Notably, the test also examines whether a man is at risk of developing breast and prostate cancers.

Report for BRCA1/2 (selected variants), which evaluates an individual's risk of developing multiple cancer types, according to a press release. About 1 in 40 individuals of Ashkenazi Jewish descent has one of these three variants. Additionally, most cases of cancer are not caused by hereditary gene mutations but are thought to be caused by a wide variety of factors, including smoking, obesity, hormone use and other lifestyle issues. Furthermore, only a small percentage of Americans carry one of these 3 mutations. To win approval, the company submitted data showing its instructions and reports are easy to understand.

Africa meat as World Health Organization declares listeriosis outbreak 'largest ever',
It is reported that so far 180 people country-wide have died from listeriosis , which has sparked panic across the country. Zambia's health minister Chitalu Chilufya said the ban would also include dairy products, vegetables and fruits.

The Food and Drug Administration decision is a step forward for the evolving world of consumer genomics.

The regulator said it reviewed data for the company's test under a regulatory pathway for low-to-moderate risk devices that are not equivalent to an already marketed device. The agency also outlined special controls created to assure test's accuracy and reliability.


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