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Roche's HIV-1 test approved in Europe

Roche has announced that it has received CE Mark certification for its dual-target HIV-1 test

Roche has announced that it has received CE Mark certification for its dual-target HIV-1 test.

This certification allows the product, which amplifies and detects two separate regions of the HIV-1 genome simultaneously, to be sold for clinical use in the European Union. According to the company, this provides reliable test results even when mutations are present.

"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."

HIV is a retrovirus that infects cells of the human immune system. In the early stages of infection, the person experiences no symptoms. Untreated, HIV will usually develop into AIDS within 10 to 15 years.

Roche's test is highly sensitive and can detect both very low and very high levels of the virus, a key indicator of the need for more or less aggressive treatment.

16th December 2008


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