FDA OKs Direct-to-Consumer Cancer Mutation Test


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
Pharmacist selling medications in the pharmacy | Image Credit: rh2010 - stock.adobe.com
BillionPhotos.com - stock.adobe.com
Whole psilocybin mushroom in a clear medication capsule | Image credit: Zim - stock.adobe.com
Patient suffering from atopic dermatitis -- Image credit: Nikkikii | stock.adobe.com
Image credit: Fabio Balbi | stock.adobe.com
Image credit: Melita - stock.adobe.com
Atopic dermatitis on a patient's hand -- Image credit: Ольга Тернавская | stock.adobe.com
cropped view of man performing chest compression on dummy during cpr training class - Image credit: LIGHTFIELD STUDIOS | stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.