Test For Breast Cancer Gene Will Be Available In Weeks

Georgia Reed
March 8, 2018

In a statement, the FDA said that the three mutations 23andMe's test evaluates are BRCA1/2 variants that occur most commonly in people of Ashkenazi Jewish descent.

The test analyzes DNA collected from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer. It is important to note that the test only detects 3 out of the more than 1,000 known breast cancer mutations. She works for and mentors other survivors at Carolina's Breast Friends, an organization which provides compassion and support to people going through breast cancer.

US regulators have approved the first direct-to-consumer breast cancer gene test. "But it has a lot of caveats", said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.

Powerball jackpot now above $300 million
The average American citizen spends about $200 a year on the lottery, with varying averages depending on the state. It became even harder to score a Mega Millions jackpot after the matrix of balls was altered in October 2017.

The Personal Genome Genetic Health Risk Report was first approved last April to provide information for a broad range of genetic disorders. 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. The test should not be used as a substitute for regular cancer screenings, he said.

Report for BRCA1/2 (selected variants), which evaluates an individual's risk of developing multiple cancer types, according to a press release. Due to the prevalence of other mutations, the test can not determine overall cancer risk, according to the FDA.

The vast majority of people with these genetic mutations have ancestral ties to the Ashkenazi Jewish population formerly living in central Europe and Russian Federation. The agency also noted that a majority of cancers are caused by lifestyle factors, such as smoking, obesity, hormones, and other habits. As part of the process, the FDA examined user comprehension data, using representative GHR test reports showing instructions and reports were generally easy to follow for the consumer. They provide information on what the results might mean and where to get additional information.

Other reports by

Discuss This Article