Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. availability of a new HIV-1 viral load test based on the company's proprietary dual-target approach. The COBAS TaqMan HIV-1 Test v2.0 for use with the High Pure System enables labs to combine an FDA-approved process for manual specimen preparation with an automated real-time PCR analyzer for amplification and detection.
"The availability of this new test will enable more labs, clinicians and patients to have access to Roche's innovative HIV technology," said Whitney Green, senior vice president, Molecular Diagnostics, for Roche Diagnostics Corporation. "The dual-target approach is helping to improve the ability of physicians to monitor viral load so they can effectively manage the treatment of people living with HIV."
Approved by the U.S. Food and Drug Administration (FDA) in July, the test utilizes the High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS TaqMan 48 Analyzer for automated amplification and detection. It targets two highly conserved regions of the Human Immunodeficiency Virus (HIV)-1 genome and avoids any regions which are current drug targets, thus providing reliable test results even when mutations are present.
The addition of the HIV-1 Test v2.0 completes Roche's High Pure System offering, which also provides FDA-approved processes for manual specimen preparation for Hepatitis C and Hepatitis B testing via automated real-time PCR. With the approval of this test, labs can consolidate HIV-1 amplification and detection on the same platform (COBAS TaqMan 48 Analyzer) used for HCV and HBV viral load monitoring assays for use with the High Pure System.