FDA authorizes test for detecting HIV drug resistance mutations

The FDA has authorized marketing of Vela Diagnostics' test to detect HIV Type 1 drug resistance mutations.

The test uses next generation sequencing technology, making it the first time the FDA has cleared an assay for use in the U.S. that uses NGS to test for HIV drug-resistant mutations.

The FDA said physicians can use the test to gather the information they need to tailor antiviral treatments to the genetics of individual patients.

According to a CDC report cited by the FDA, the percentage of people living with HIV around the world that have resistance to some HIV drugs has increased from 11 percent to 29 percent since 2001.

Read the full news release here.

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars