The U.S. Food and Drug Administration has approved a Premarket Approval Application for a new HIV testing technique developed by Roche Diagnostics in Indianapolis. The company says the technique could increase the likelihood of early detection of HIV infection.
The technique, known as the Elecsys HIV combi PT assay, has the ability to detect both antigen and antibodies simultaneously, which could increase its efficacy in early detection. Roche says it could also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in people older than two years of age and in pregnant women.
"The approval of this highly sensitive and specific assay demonstrates our ongoing commitment of expanding Roche’s already broad testing menu for infectious diseases," said Jack Phillips, chief executive officer of Roche Diagnostics. "With the addition of this assay, laboratories will be able to screen for common co-infections, such as Hepatitis C and Syphilis, which can be tested simultaneously with HIV, reducing the need for sample splitting and additional analyzers."
According to the FDA’s website, an approved PMA effectively gives the applicant a license "for marketing a particular medical device."