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Ortho Clinical Submits PMA Applications for HIV, HBV Assays

NEW YORK (360Dx) – Ortho Clinical Diagnostics said on Thursday that it has submitted a premarket approval application to the US Food and Drug Administration for its Vitros HIV Combo immunodiagnostic assay on its Vitros 3600 immunodiagnostic system. 

The firm also submitted premarket approval supplements for two hepatitis B immunodiagnostic assays — the HBeAg Assay and the Anti-HBe Assay. Although the hepatitis B assays have already been approved for marketing in the US for use on Ortho's Vitros Eci/Eciq immunodiagnostic system, the supplements seek approval to run them on Ortho's Vitros 3600 immunodiagnostic system and the Vitros 5600 integrated system.

The Vitros HIV combo is a fourth-generation assay designed to detect HIV-1 acute infection earlier than previous generations of HIV assays, Ortho said. The assay received CE marking in 2016, and is available in Europe and other countries that accept the mark.

"The submissions represent our ongoing commitment to strengthening our menu, particularly in immunoassay, and to offering our menu on Ortho's Vitros systems to help labs manage workflows more efficiently and effectively," an Ortho spokesperson said in an email.

According to World Health Organization estimates, 37 million people worldwide live with HIV today. Of the more than 1.2 million people in the US living with HIV, more than 200,000 have an unknown status, contributing to 54 percent of new infections, Ortho said.

An estimated 240 million people worldwide currently live with chronic hepatitis B, a life-threatening infection of the liver, the firm added.