Roche Laboratories in Pleasanton announced this week that is has received CE mark certification for its new dual-target HIV-1 drug test, allowing it to be sold in the European Union and those countries accepting CE Marked products.
The test simultaneously amplifies and detects two separate regions of the HIV-1 genome, which are not subject to selective drug pressure. This unique, dual target design allows for more reliable results to confidently and effectively diagnose HIV-1 infection.
Roche representatives said the new dual-target HIV-1 qualitative test, v2.0, works with both plasma and dried blood spot collection cards to facilitate testing, and more importantly make sample collection and transportation easy, even from the smallest infant in the most rural area.
The new test will help increase access for early infant HIV diagnosis, the company said.
The collection card and the need for more sensitive and accurate information to diagnose babies early in their life and patients across many African countries is instrumental to facilitate the state of the art healthcare required for the region. The HIV-1 dual target qualitative test and sample cards eliminate need for refrigeration, drastically reduces the volume of blood to be stored or transported, and the stress for the mother and the child is dramatically improved.
"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," stated Paul Brown, president of Roche Molecular Diagnostics. "With this new solution from Roche, we are reiterating our commitment to healthcare solutions that make a real difference for patients."
Headquartered in Basel, Switzerland, Roche's Pleasanton-based Molecular Diagnostics facilities are located in Hacienda Business Park at 4300 Hacienda Dr.