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New Roche Dual Target HIV-1 Test Approved for Use in European Union
Date:12/15/2008

PLEASANTON, Calif., Dec. 15 /PRNewswire/ -- Roche announced today that its innovative dual-target HIV-1 test has received CE Mark certification, allowing it to be sold for clinical use in the European Union. The COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) HIV-1 Test, v2.0 utilizes a unique design to simultaneously amplify and detect two separate regions of the HIV-1 genome. This approach provides reliable test results even when mutations are present. The test uses Roche's proprietary fully automated real-time PCR technology to quantify the amount of HIV-1 RNA in a patient's blood.

"HIV mutations are a serious problem. Because it is impossible to predict when these mutations will occur, we have designed this test to detect all HIV-1 (Group M and O) strains," said Daniel O'Day, President and CEO of Roche Molecular Diagnostics. "This innovative fully-automated solution will provide reliable results for laboratories and physicians to more confidently and efficiently treat HIV-1 patients undergoing therapy."

It is critical for viral load monitoring tests to be able to quantify very low and high levels of virus, an indicator of the need for more or less aggressive treatment. The test is highly sensitive and can detect the World Health Organization HIV-1 RNA Standard in EDTA plasma as low as 20 copies per milliliter of patient sample. The test can also accurately quantify the amount of HIV in a patient sample up to 10 million copies/mL representing a broader dynamic range than previous generation tests.

About the COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) System

The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HIV Test, v2.0 is the first dual-target test to be offered on the COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) System. The test is designed for use on the fully automated, real-time PCR platform, providing sample-in/results-out capability. The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) System is flexible
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SOURCE Roche
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