Monday, March 19, 2018

First Home Testing Kit for Breast Cancer Mutations

The FDA has granted a genetic testing company the rights to distribute an at-home saliva test in order to determine one’s risk for three breast cancer gene mutations. 23andMe now offers these screenings as part of their Health and Ancestry product listed at $199. These saliva samples also provide individuals with ancestral history on their country of origin, as well as the genetic health risks that are involved in said areas. The test takes approximately two weeks to be analyzed and have a return of the results. Women are at an extremely higher risk of developing breast and ovarian cancer if they test positive for one of the BRCA1 and BRCA2 gene mutations. Men are also at a higher risk if they possess one of these genes, however it is much more uncommon for men to develop breast cancer (however not impossible). These mutations however, may lead to a higher risk of prostate cancer in men. Clients need to be aware; because if the at-home test states that you are negative for the gene mutations, it does NOT mean that you can’t get breast/ovarian cancer, since there are over 1,000 mutations associated with the BRCA gene. The Ashkenazi Jews (a derivative of Judaism of central Europe) are more likely to test positive for all three gene mutations than any other ethnical group. Donald St. Pierre of the FDA states that, “The test provides information to certain individuals who may be at increased breast, ovarian or prostate cancer risk and who might not otherwise get genetic screening, and is a step forward in the availability of direct-to-consumer genetic tests…this test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that increase or decrease cancer risk”.

23andMe had originally reported these gene mutations back in 2010 without being approved by the FDA, however the FDA has issued them a warning in 2013. This caused the company to stop providing all health data until the FDA had reproducible results, and was proven statistically significant. A warning label is also not made mandatory on all test kits, stating that negative results do not rule out other genetic mutations associated with cancer risks, tests should not be used to determine medical treatment, tests should not be a substitute for a doctor’s visit, and that positive test results must be reviewed with their doctor in order to determine proper medical treatment. Ann Wojcicki the CEO of 23andMe, said that this product was made available due to high public demand.

This article was interesting to say the least.  It is nice for people with a background history of breast cancer to may find a a little piece of mind if they are positive or negative for these gene mutations, however I do not know about the quality of these tests.  $199 seems a little to good to be true to me, and since it is a newer product, I am not sure if I would trust the results or not.  I would personally stick to testing done through a licensed physician, or through a specialist with a more reputable product.

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