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Roche Includes Cobas HIV-1/HIV-2 Test in Global Access Program

NEW YORK (GenomeWeb) – Roche announced today the inclusion of its Cobas HIV-1/HIV-2 nucleic acid test in its Global Access Program.

The CE-marked test enables health professionals to distinguish between HIV-1 and HIV-2 and provides users flexible PCR testing with serum, plasma, and validated dried blood spot (DBS) collection card sample types to improve treatment options based on subtype infections in rural locations, Roche said.

The test runs on the fully automated Cobas 6800/8800 systems.

Current serology methods, which depend on the ability to detect antibody response, take between two and four weeks to diagnose HIV. Because of the greater sensitivity of PCR technology, NATs like the Cobas HIV-1/HIV-2 test can shorten this crucial period by up to a week and prevent further spread of the disease, Roche said.

"This test will enable more accurate diagnosis of subtype infection and thus greatly advance controlling transmission, scaling up access to relevant diagnostics and eradicating the HIV/AIDS epidemic" Uwe Oberlaender, head of Roche's Molecular Diagnostic Business Unit, said in a statement.

Roche's Global Access Program for HIV viral load testing was created in 2014 in partnership with the Joint United Nations Program on HIV/AIDS (UNAIDS), the Clinton Health Access Initiative (CHAI), the US President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to fight AIDS, TB and Malaria.

Roche said at the time that the program was in response to the Diagnostics Access Initiative launched also in 2014 to improve laboratory capacity so that AIDS patients can access effective, high-quality HIV treatment services. It added that expanding the use of diagnostics will be crucial to achieving the UNAIDS 90:90:90 goals by the year 2020.

That initiative aims to have 90 percent of all people living with HIV know their HIV status; 90 percent of all people diagnosed with HIV infection to receive antiretroviral therapy; and 90 percent of all people receiving antiretroviral therapy to have durable viral suppression.