FDA Approves Assays for Hepatitis B Diagnostic System

The US Food and Drug Administration (FDA) has granted approval to a pair of assays designated for the use with an immunodiagnostic system that detects hepatitis B (HBV) in individauls.

The VITRO Immunodiagnostic Products HBeAg Assay and Anti-HBe Assay, from Ortho Clinical Diagnostics, have been approved in use with the VITROS 3600 Immunodiagnostic System and VITROS 5600 Integreated System. The assays are intended to aid in the diagnose of HBV in individuals with acute or chronic versions of the disease, or are in recovery from infection.

With its approval, patients and physicians are capable of consolidating all their tests onto Ortho’s VITROS System and manage a greater rate of diagnostic tests.

Swift and accurate HBV diagnosis is considered critical for the condition, as it’s become a more commonly vaccinated disease for newborns. According to a report in September 2017, chronic HBV infection occurs in as many as 90% of all infants with HBV at birth or withing their first year of life. Current vaccinations for the disease are 75% to 99% effective in preventing perinatal HBV infection.

According to analysis from the US Center for Disease Control and Prevention (CDC), an estimated 240 million people worldwide have chronic HBV—with a portion of patients not even being diagnosed. Ortho’s history in hepatitis care spans 3 decades, when they first introduced a hepatitis C antibody detection test in 1989.

In a statement regarding the FDA approval, Robert Yates, Ortho chief operating officer, said the company is committed to designated assays that help patients diagnoses infectious diseases as early as possible in the disease cycle, “while also supporting labs in managing their workloads as effectively and efficient as possible.”

“The FDA's approval of our hepatitis B assays for use on our VITROS automated analyzers is an important step toward achieving those goals,” Yates said.