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# FDA Approves Expanded Use for Roche HCV Test
- URL: https://www.fdaweb.com/fda-approves-expanded-use-for-roche-hcv-test/
- Published: 2016-03-21T12:00:00.000Z
- Updated: 2026-09-14T20:50:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135144

> FDA has approved Roche’s hepatitis C virus (HCV) quantitative RNA test to be used as an aid in diagnosing HCV infection for certain patient populations. Results from the COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 can now be used to confirm an active hepatitis infection, in addition to providing an accurate measurement of how much virus is in a patient’s blood, to help a physician determine the best course of treatment, according to the company. This expanded indication is in addition to its approved use as a viral load test to help physicians assess a patient’s response to antiviral therapy. The real-time polymerase chain reaction-based HCV test is designed for use on Roche’s fully automated COBAS AmpliPrep/COBAS TaqMan System.