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FDA Approves 23andMe's Home Test Kit For 3 BRCA Gene Mutations

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Testing for breast cancer and other diseases caused by BRCA1 and BRCA2 genetic mutations becomes easier now that the U.S. Federal Drug Administration has approved 23andMe's genetic test.

The test kit includes an instruction packet and a tube for saliva sample collection with a unique barcode. Each consumer must use this barcode for online registration so the company knows who is the owner of the tube.

After filling the tube with saliva, it must be mailed back immediately to 23andMe's laboratory. It will be processed by medical experts to determine if a consumer's DNA contains three variants of the BRCA1 and BRCA2 mutations, which have been associated with increased risk for breast, ovarian, and prostate cancer. They use a 24-format genotyping chip called the Illumina HumanOmniExpress.

After six to eight weeks, consumers will receive an e-mail indicating that their test results are already available. Details can only be accessed by logging in to a secure online account. Such is implemented to ensure complete privacy.

The FDA approved the 23andMe's direct-to-consumer test kit on March 6 but federal regulators cautioned about its "caveats."

Donald St. Pierre, acting director at the FDA's Office of In Vitro Diagnostics and Radiologic Health, warns that only a few number of Americans have the three variants detected by the test kit. Moreover, it also misses the many other BRCA variants, which actually raise a person's risk for certain cancers. Therefore, it should not be considered as an alternative to conventional cancer screening.

What Are BRCA1 And BRCA2 Genetic Mutations?

BRCA1 and BRCA2 are genes instructing the production of certain proteins that suppress the development of tumors. If any of the two is altered, it ceases to function properly and results in additional mutations that are often cancerous.

The National Cancer Institute states that BRCA1 and BRCA2 are inherited mutations that can come from either of an individual's parents. If the mother or father has one of the genetic mutations, there is a 50% chance that it will be passed on to their children.

To determine if a child is carrying such genetic mutations, testing is required as diseases associated with BRCA1 and BRCA2 still manifest even when their copy of the gene appears to be normal.

The three variants of the genetic mutations, which 23andMe's test kit can detect, are prevalent among those with Ashkenazi Jewish ancestry. One out of 40 people with this ethnicity has either a BRCA1 or BRCA2 mutation.

In particular, 23andMe reveals that women with any of the three mutations have up to 85 percent risk of developing breast cancer when they reach the age of 70.

After demonstrating 99 percent accuracy and precision, 23andMe's test kit can now be ordered online. The California-based company has the same warning as the FDA, stating that results should not be used as a substitute for cancer screening.

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