23andMe Has FDA Approval for Genetic Test for Breast Cancer



23andMe has received the first ever Food and Drug Administration approval for a direct-to-consumer genetic test for cancer risk for its BRCA1/BRCA2 (Selected Variants) report. This is a major milestone in consumer health empowerment.

The 23andMe genetic test for cancer risk for BRCA1/BRCA2 (Selected Variants) report covers three variants in the BRCA1 and BRCA2 genes associated with increased risk for breast, ovarian, and prostate cancer. These variants are most common in people of Ashkenazi Jewish descent.

23andMe believes that 23andMe customers who have one or more of these variants have the right to know about this risk, if they choose. Many women who have a higher risk variant in the BRCA1 or BRCA2 genes remain unaware of their heightened genetic risk for breast and ovarian cancer until a doctor diagnoses them with cancer.

The majority of people who are diagnosed with breast cancer are women – but it affects men, too. Men with one of the BRCA1 or BRCA2 variants that 23andMe tests for are at higher risk for male breast cancer, and may have a higher risk of certain other cancers as well. 23andMe points out that men who find out they have one of the tested BRCA variants can alert female relatives who might benefit from knowing about their potential genetic risk.

Years ago, 23andMe did a small study about how people react to unexpected BRCA findings. The researchers of that study found that the results did not induce anxiety. Instead, the unexpected findings prompted people to have conversations with their family about the finding.

The FDA, in the past, suspended 23andMe from offering genetic health risk reports (including the BRCA1/BRCA2 report) to customers. Since then, 23andMe went through a FDA review of their ability to accurately detect these variants and to report genetic health risk information to customers in a way that could be easily understood. Now, the FDA has decided that 23andMe has met those criteria.

There are some things to know about 23andMe’s BRCA1/BRCA2 (Selected Variants) report. It does not diagnose cancer. It cannot rule out your chances of getting cancer. It does not cover most of the thousands of BRCA1 and BRCA2 variants associated with cancer risk. It doesn’t cover other genes that are associated with hereditary cancer, or non-genetic factors such as environment and lifestyle.

23andMe recommends that customers should confirm the results of their BRCA1/BRCA2 (Selected Variants) report with a healthcare provider in a clinical setting before taking any medical action.

Related Articles on FamilyTree.com:

* 23andMe Expands Ancestry Composition – Adds 120 Regions

* FDA Allows 23andMe to Sell Genetic Tests for Disease Risk to Consumers

* 23andMe Releases Genetic Weight Report

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