Roche receives CE Mark approval for new HIV test

Roche has announced that its new dual-target HIV-1 qualitative test has been approved for use in Europe.

The test has been granted CE Mark certification, allowing it to be sold for clinical use in Europe and other countries accepting this accreditation. Its availability will help increase access for early infant HIV diagnosis.

Roche's new offering simultaneously amplifies and detects two separate regions of the HIV-1 genome, which are not subject to selective drug pressure. This dual-target design allows for more reliable results to confidently and effectively diagnose infections.

It works with both plasma and dried blood spot collection cards to facilitate polymerase chain reaction testing, making sample collection and transportation easy in all cases.

Paul Brown, president of Roche Molecular Diagnostics, said: "The ability to determine the HIV status of an infant as early as six weeks is crucial to determining the appropriate care and support for HIV-positive babies."

Last year, the company agreed a deal with the Medicines Patent Pool to increase global access to Valcyte, its therapy for cytomegalovirus, a viral infection that can result in a loss of vision and greater risk of death in people living with HIV.