Breast Cancer Home Testing For Three Out Of More Than 1,000 BRCA Mutations Gets FDA Approval

FDA approved a new test developed by 23andMe can detect three types of BRCA mutation without a doctor's involvement.

Breast cancer patient Susanne Ostlund
Justin Sullivan / Getty Images

FDA approved a new test developed by 23andMe can detect three types of BRCA mutation without a doctor's involvement.

The Food and Drug Administration green-lighted a test from 23andMe that allows consumers to test their risk for three mutations of breast cancer. Consumers can do the said test at home without the need to consult a doctor.

On Tuesday, March 6, U.S. FDA announced that the genetic company 23andMe would be allowed to administer the test without the need for a doctor’s prescription. The test can detect BRCA1/BRCA2 mutations, a type of breast cancer which is most common in individuals of Ashkenazi or Eastern European Jewish descent. The said mutation affects about two percent of individuals with the said ancestry as determined by a study published by the New England Journal of Medicine.

In a press release, FDA clarified that BRCA1/BRCA2 are not the most common in the general population.

The approval of this self-administered test will, most likely, cause much debate as to whether people should have access to this kind of information without the assistance of professionals.

Testing For Breast Cancer Mutations

The testing process is quite straightforward as outlined in the FDA’s statement.

“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.”

Since the test can only identify three out of more than 1,000 known breast cancer mutation, getting a negative result on this test does not mean that an individual does not have a high risk of getting breast cancer.

Several Caveats

Acting Director Donald St. Pierre of the FDA’s Office of In Vitro Diagnostics and Radiological Health opines that this genetic test is a step forward in the field of genetic screening for prostate, breast, and ovarian cancer. However, “it has a lot of caveats.”

The breast cancer mutation test by 23andMe tests for only three mutations which affects a small percentage of the American population. St. Pierre cautioned that this test should not be a substitute for seeking a doctor’s advice on cancer screening and of consulting with a professional to reduce the risk of cancer, based on lifestyle and hereditary factors.

Dr. J. Leonard Lichtenfeld of the American Cancer Society also had much to say about the implications of this test.

“The implications of this test are not quite the same as a slightly elevated cholesterol or uric acid. The presence of a BRCA abnormality has meaning, not only for your personal assessment of your health, but for others who have a legitimate interest in your health such as life insurance companies and disability insurance companies. If you are 30 years old and know you have a BRCA mutation, you are obligated to share that information if an insurance company asks the question, such as: Do you have any known health conditions? I am not saying that’s a good or bad thing; merely that it is one of the nuances some folks may care about however don’t spend much time thinking about.”

In addition, the said test should not be used to proceed with treatment. The user still needs to undergo further testing to confirm the results. When used without the aid of a genetic counselor or a doctor, there could be serious risks in using this breast cancer screening kit.