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First Direct-to-Consumer Test Approval by FDA for Genetic Cancer Risk

July, 2018

cancerCancer is a group of disease in which abnormal cells divide without control and can invade nearby tissues. There are more than 100 types of cancer that includes breast cancer, skin cancer, lung cancer, colon cancer, prostate cancer, lymphoma, and others. WHO reported that cancer is the second leading cause of death across the globe, and was responsible for 8.8 million deaths in 2015. According to American cancer society, there will be an estimated 1,688,780 new cancer cases diagnosed and 600,920 cancer deaths in the US in 2017.

23andMe’s at-home genetic test

US based 23andMe, Inc., the leading personal genetics company received the first-ever FDA authorization for a direct-to-consumer genetic test for cancer risk in March 2018. This allows 23andMe to provide the test to the customers without a prescription and will provide information on three genetic variants of BRCA1 and BRCA2 genes which is known to be highly prevalent in breast, ovarian and prostate cancer. These variants may also be associated with an increased risk for certain other cancers and are most prevalent in those of Ashkenazi Jewish descent when compared to other ethnicities. About 1 in 40 individuals of Ashkenazi Jewish descent has one of these three variants and the risk of risk of cancer is high in that community. This authorization is extremely valuable for those who might not be aware of their Ashkenazi Jewish descent or aren’t familiar with their family history of cancer. In order to establish safety and effectiveness for this authorization, the company has demonstrated a high level of accuracy (greater than 99% concordance to Sanger sequencing) and precision (demonstrated by studies yielding greater than 99% reproducibility and repeatability).

– Arpitha Shetty
Research Analyst
Infoholic Research