Published: Thu, March 08, 2018
Medicine | By Daryl Nelson

FDA approves first at-home test for cancer risks

FDA approves first at-home test for cancer risks

The company can report back the three mutations in the BRCA1 and BRCA2 genes that are the most common in the Ashkenazi Jewish population.

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.

This test is far from definitive: There are thousands of mutations on the BRCA genes alone that can raise a person's risk of developing cancer, and 23 andMe's test can only identify three.

Today (March 6), the US Food and Drug Administration approved 23 andMe's at-home genetic test as a diagnostic tool for increased risk of breast, ovarian, and prostate cancer. It's the first at-home BRCA1/BRCA2 screening tool to be approved for use in the United States, and could significantly raise the number of people aware of having the cancer-related mutations. Results also should not be used to guide treatment such as surgery or hormones, the FDA said. It can not determine a person's overall risk of developing cancer.

Nokia 9 is Expected to Release in August with Premium Specs
HMD Global is said to be gearing up to launch two new flagship Nokia phones in its 2018 line-up very soon. There are rumors about Nokia 9 that the fingerprint sensor will be given in the handset display itself.

The approval comes four years after the FDA threw the brakes on 23andMe's race across the consumer genetic testing landscape in a November 2013 warning letter that amounted to a cease-and-desist order.

These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population.
As with the first 10 tests, the company is authorized to provide the results directly to the customer.

These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities, according to the FDA. Those decisions should be based on confirmatory tests and genetic counselling. 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 agency also set a condition known as special controls, clarifying its expectations for assuring test accuracy and reliability.

Like this: