Roche: gets FDA nod for HIV differenciation test
(CercleFinance.com) - Roche has received authorisation from the United States' Food and Drug Administration for a diagnostic test that detects HIV-1 and HIV-2 infections, the company said on Tuesday.
The FDA approved the cobas HIV-1/HIV-2 qualitative test for use on its automated cobas 6800/8800 system in the US, allowing healthcare professionals to differentiate HIV-1 and HIV-2, an important distinction needed to identify appropriate treatment options, the Swiss drugmaker said in a statement.
Current serology-based testing methods rely on the ability to detect an antibody or antigen response, often failing to identify an infection if the person is tested prior to having a detectable antibody or antigen response.
Roche's higher sensitivity PCR technology can reduce this time-to-detection period by at least one week, the company said.
Copyright (c) 2020 CercleFinance.com. All rights reserved.
The FDA approved the cobas HIV-1/HIV-2 qualitative test for use on its automated cobas 6800/8800 system in the US, allowing healthcare professionals to differentiate HIV-1 and HIV-2, an important distinction needed to identify appropriate treatment options, the Swiss drugmaker said in a statement.
Current serology-based testing methods rely on the ability to detect an antibody or antigen response, often failing to identify an infection if the person is tested prior to having a detectable antibody or antigen response.
Roche's higher sensitivity PCR technology can reduce this time-to-detection period by at least one week, the company said.
Copyright (c) 2020 CercleFinance.com. All rights reserved.