Roche's new dual-target HIV-1 test approved in Europe

Dec 15 2008

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 AmpliPrep/COBAS TaqMan 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.

The COBAS AmpliPrep / COBAS TaqMan HIV Test, v2.0 is the first dual-target test to be offered on the COBAS AmpliPrep / COBAS TaqMan System. The test is designed for use on the fully automated, real-time PCR platform, providing sample-in/results-out capability. The COBAS AmpliPrep / COBAS TaqMan System is flexible and customizable to meet the space and workflow needs of any laboratory. In 2005, Roche received CE Mark certification for the full viral load monitoring menu (HIV-1, HBV, and HCV) on the system.

According to estimates by the World Health Organization (WHO) and UNAIDS, 33.2 million people were living with HIV at the end of 2007. That same year, some 2.5 million people became newly infected, and 2.1 million died of AIDS, including 330,000 children.

The human immunodeficiency virus (HIV) is a retrovirus that infects cells of the human immune system, destroying or impairing their function. In the early stages of infection, the person has no symptoms. Within 10-15 years an HIV infection will develop into acquired immunodeficiency syndrome (AIDS); antiretroviral drugs can slow down this process even further.

HIV is transmitted through unprotected sexual intercourse (anal or vaginal), transfusion of contaminated blood, sharing of contaminated needles, and between a mother and her infant during pregnancy, childbirth and breastfeeding.

The ability of HIV to mutate itself in the presence of antiretroviral drugs can lead to treatment failure, increased direct and indirect health costs associated with the need to start more costly second-line treatment for patients, the spread of resistant strains of HIV and the need to develop new anti-HIV drugs.