March 08, 2018 06:22 PM
ROCHESTER, NY (WHEC) - You can now test your own risk of cancer through an at-home kit. For the first time, the FDA has authorized a direct-to-consumer genetic test through 23andMe.
It will “provide customers, without a prescription, information on three genetic variants found on the BRCA1 and BRCA 2 genes known to be associated with higher risks for breast, ovarian, and prostate cancer,” explains the company. 23andMe will be the first and only direct-to-consumer genetics company to get authorization from the FDA to test for cancer risk without a prescription.
The company states, “These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities. About 1 in 40 individuals of Ashkenazi Jewish descent has one of these three variants. Women with one of these variants have a 45-85% chance of developing breast cancer by age 70.”
While there are benefits to having the test so accessible, local medical experts have concerns over results being misleading to those who get negative results.
“It is not that as a profession we’re against this testing, it is simply that it needs to be paired with good education,” explained Jessica Salamone, CGC. As a Certified Genetic Counselor with Elizabeth Wende Brest Care, she explained the testing will only benefit a small portion of the population.
“If you have any northern European, Caucasian, African American, Southeast Asian decent this test isn’t even applicable for you,” she explained.
Kimberly Press is a breast cancer survivor, being diagnosed following a routine mammogram.
“I did not have the gene once I was tested. The diagnosis for breast cancer is beyond scary, but so is waiting for those test results,” expressed Press. She added the importance of having a medical professional you trust to guide you through the results and treatment plan.
Medical experts believe this could be the first step in making health screenings more accessible to people.
23andMe was also granted authorization by the FDA back in 2015 to market the first direct-to-consumer genetic test for Bloom Syndrome. The company reports those efforts have since enabled it to bring more than 40 carrier status reports directly to customers.
“These reports convey risk for diseases that may be passed to offspring,” states the company’s website.
23andMe was also granted the ability to give consumers genetic health risk reports in 2017.
To date, the company has launched nine reports for a variety of genetic health risks.
Updated: March 08, 2018 06:22 PM
Created: March 08, 2018 05:52 PM
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