Of course, the test shouldn't be taken as the be all, end all of cancer risk - nor is it meant as a replacement for a proper screening.
It doesn't find all cancer-causing genes - not by a long shot, the FDA said. It is important to note that the test only detects 3 out of the more than 1,000 known breast cancer mutations. The use of the test carries significant risks if individuals use the test results without consulting a physician or genetic counselor.
"Consumers who test positive for these mutations need to be retested in a clinical setting under the supervision of a medical professional before moving forward with any medical decisions", the group said.
Personal genetics company 23andMe announced yesterday that it's received the first-ever FDA authorization for genetic testing for cancer risk. The American Cancer Society says this year, it will be diagnosed in 260,000 women and a few men, and will kill almost 41,000.
The agency stressed that this test should not be used as a replacement for a visit to the doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk.
ME emergency department visits for opioid overdoses jumped 34 percent in 2017
And common painkillers don't have side effects, such as leading people into opioid addiction, the study concluded. The number of visits rose 30 percent across the country from July 2016 to September 2017.
BRCA1 and BRCA2 are DNA fix genes. As the service notes, around half of BRCA carriers who offered medical history in a study don't report cancer history among immediate relatives. It can not determine a person's overall risk of developing cancer.
These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities. The variants also are associated with ovarian cancer in women and breast and prostate cancer in men. About 45 percent of women with faulty BRCA2 genes will.
23andMe founder and CEO Anne Wojcikci acknowledged that most cancer is not hereditary and that this test does not cover many variants tied to an even higher cancer risk. That accounts for a small percentage of people.
For the first time the FDA has granted permission to market a direct-to-consumer genetic test to check for BRCA mutations that are associated with breast and ovarian cancer. Results also should not be used to guide treatment such as surgery or hormones, the FDA said. The agency also outlined special controls created to assure test's accuracy and reliability.