23 andMe can now offer prescription-free cancer risk tests

Kristen Gonzales
March 8, 2018

Test For Breast Cancer Gene Will Be Available In Weeks The FDA approved the first test that people can get without a doctor to see if they carry a genetic mutation that increases their risk for cancer.

The Personal Genome Genetic Health Risk Report was first approved last April to provide information for a broad range of genetic disorders.

The test will report on three variants in the BRCA1 and BRCA2 genes associated with a significantly higher risk of breast and ovarian cancer in women-as well as breast cancer in men-by analyzing DNA from a self-collected saliva sample. The FDA cautions that a negative result from the test doesn't rule out that a person has other BRCA mutations or an increased risk of cancer.

More news: Tech's biggest takeover could be blocked by the USA government

Report for BRCA1/2 (selected variants), which evaluates an individual's risk of developing multiple cancer types, according to a press release. "But it has a lot of caveats", Donald St. Pierre, of the FDA Center for Deices and Radiological Health, said in a statement. But those mutations are not the most common BRCA mutations in the broader population. Due to the prevalence of other mutations, the test can not determine overall cancer risk, according to the FDA. "The variants may also be associated with an increased risk for certain other cancers". The agency also noted that most cancers do not arise from genetic mutations but more likely from a combination of factors, including lifestyle and environmental factors.

The Food and Drug Administration decision is a step forward for the evolving world of consumer genomics. For all of these reasons, it is important for patients to consult their health care professional who can help them understand how these factors impact their individual cancer risk and what they can do to modify that risk.

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 test report provides information describing what the results might mean, how to interpret results and where additional information about the results may be found. The agency also outlined special controls created to assure test's accuracy and reliability.

Other reports by TheSundaySentinel

Discuss This Article