FDA OKs Direct-to-Consumer Cancer Mutation Test

Article

A new direct-to-consumer test analyzes saliva for 3 BRCA variants that may elevate the risk of various types of cancer.

Officials with the FDA authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/2 (selected variants), which evaluates an individual’s risk of developing multiple cancer types, according to a press release.

The newly-approved test is the first direct-to-consumer (DTC) product to examine 3 specific BRCA1/2 mutations that are common among patients of Ashkenazi Jewish descent; however, the mutations are not the most common variants among the general population, according to the FDA.

The GHR Report examines DNA from a self-collected saliva sample to determine a woman’s risk for breast and ovarian cancers. Notably, the test also examines whether a man is at risk of developing breast and prostate cancers.

The FDA cautions that the test only detects 3 out of more than 1000 BRCA mutations, meaning that a negative result may not necessarily indicate whether or not a patient carries another variant that increases the risk of cancer.

For more information, go to SpecialtyPharmacyTimes.com.

Related Videos
A panel of 4 experts on breast cancer
A panel of 4 experts on breast cancer
Pride flags during pride event -- Image credit: ink drop | stock.adobe.com
A panel of 4 experts on breast cancer
A panel of 4 experts on breast cancer
Female Pharmacist Holding Tablet PC - Image credit: Tyler Olson | stock.adobe.com
African American male pharmacist using digital tablet during inventory in pharmacy - Image credit: sofiko14 | stock.adobe.com
Young woman using smart phone,Social media concept. - Image credit: Urupong | stock.adobe.com
cancer pain management | Image Credits: © Burlingham - stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.