FDA Approves First Home Test For Breast Cancer Risk

FDA Approves First Home Test For Breast Cancer Risk

FDA Approves First Home Test For Breast Cancer Risk

Around one in 400 people have BRCA mutations that can cause cancer, and is more common among those with eastern European or Jewish descent. The forthcoming kit, which will be made available without a prescription, tests for BRCA1 and BRCA2, which are linked to higher risk of ovarian, break and prostate cancer. As geneticist Eric Topol notes on The Verge, the three variants tested here only make up a small percentage of hundreds of known mutations.

Federal regulators have approved the first direct-to-consumer genetic test for breast, ovarian and prostate cancer risks. "The test should not be used as a substitute for seeing your doctor for cancer screening or counseling on genetic and lifestyle factors that can increase or decrease cancer risk". Results also should not be used to guide treatment such as surgery or hormones, the FDA said.

She said that although the company hasn't yet announced specific cancer risk mutations that it will add in the future, the approval surmounts a major hurdle. It can not determine a person's overall risk of developing cancer.

PNB Scam: Rahul Gandhi leads Congress protest against Centre
On January 31, the agency had registered an FIR pertaining to LoUs worth over Rs 6,400 crore against the diamond trader. The CBI had on Monday secured a 12-day remand of four accused arrested in the alleged PNB fraud case.

Things changed in a big way in 2017 when the FDA authorized 23andMe to provide direct-to-consumer DNA testing for 10 conditions like celiac disease, Parkinson's, Alzheimer's, and more. Anne Wojcicki, co-founder and chief executive of 23andMe, said the company's experience selling the test before 2013 in the U.S., United Kingdom and Canada had provided insight into how useful the information can be, particularly to customers who did not realize they had Ashkenazi Jewish heritage.

"For all these reasons, it is important for patients to consult their healthcare professional, who can help them understand how these factors impact their individual cancer risk and what they can do to modify that risk", the statement continued.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

Related news