FDA approves Ortho’s next-generation Vitros HIV combo test

FDA
The WHO estimates 37 million people worldwide live with HIV, with early detection and treatment vital to preventing new infections. (Andrew Harnik/AP)

The FDA approved Ortho Clinical Diagnostics’ Vitros fourth-generation HIV combination test, which detects both HIV-1 and HIV-2 antibodies and the p24 antigen, which the company says allows it to detect acute HIV-1 infections earlier than previous generations.

The approval includes the Vitros Immunodiagnostic Products HIV combo reagent pack and calibrator, for use on Ortho’s Vitros 5600 in vitro diagnostic system. The combo test has not been approved in the U.S. for use on Vitros ECi/ECiQ systems.

“Ortho is committed to expanding its assay menu to meet current guidelines and testing needs,” Jennifer Paine, Ortho’s chief product portfolio and QRC officer, said in a statement.

Your Daily Newsletter — Free

Enjoying this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. To read on the go, sign up today to get biotech news and updates delivered right to your inbox!

The company cited statistics from the World Health Organization estimating that 37 million people are living with HIV worldwide, with early detection and antiretroviral treatment vital to preventing new infections.

Clinical and technical performance was evaluated at three testing laboratories in the U.S. and at Ortho's R&D laboratories, the company said, with results confirming “competitive sensitivity and specificity when compared to a leading commercially available fourth-generation test,” according to the FDA’s instructions for use (PDF).

Assay sensitivity was evaluated on seroconversion panels, with the Vitros test showing earlier detection of acute HIV infection in six of 32 panels, as well as agreement in 25 panels, the company said.