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FDA Approves Ortho Clinical's Hepatitis B Assays

NEW YORK (360Dx) – The US Food and Drug Administration has approved two Ortho Clinical Diagnostics assays for diagnosing hepatitis B infection in individuals with acute or chronic hepatitis B, or who are recovering from hepatitis B infection, the company said today.

Ortho's Vitros Immunodiagnostic Products HbeAg Assay and Vitros Immunodiagnostic Proeducts Anti-HBe Assay are for use on the company's Vitros 3600 Immunodiagnostic System and Vitros 5600 Integrated System. The assays will allow the consolidation of all hepatitis tests onto Ortho's single high-throughput Vitro system, enabling better management of large volumes of diagnostic tests, Ortho said.

Citing statistics from the Centers for Disease Control and Prevention, the firm said that about 240 million people globally live with chronic hepatitis B.

The company last month received FDA approval to market its Sera blood-grouping reagents with its ID-Micro Typing System gel card technology for extended phenotype testing.