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DiaSorin Gets FDA Approval for Six Hepatitis B Serology Tests

NEW YORK – DiaSorin announced on Thursday it has received approval from the US Food and Drug Administration for six hepatitis B serology assays. The Saluggia, Italy-based firm said the tests now complete its hepatitis menu offering in the US market.

The six tests comprise an HBV panel. It runs on the firm's Liaison XL chemiluminescent immunoassay system which has a global installed base of 5,000 instruments, DiaSorin noted in a statement.

The approval of the hepatitis B panel is part of a 2016 strategic partnership with Beckman Coulter to bring the Liaison XL hepatitis and HIV products to the US market, the firm said. The HBV tests will be manufactured in DiaSorin's facilities in Italy and the UK and will be added to its existing and already available hepatitis panel in the US.

Approximately 2 billion people are infected by HBV worldwide, and chronic infection can lead to cirrhosis or liver cancer, the firm noted. There are approximately 20,000 new HBV cases each year in the US, and a total number of chronic infections of around 900,000. But rates of acute infection are rising and the US Centers for Disease Control and Prevention estimates that half of people with chronic HBV infection are unaware they are infected.

Through the approval of the full HBV panel, DiaSorin is now able to offer a complete testing solution for hepatitis A, B, and C in the US market. Specifically, it offers HAV total and HAV IgM for hepatitis A; Anti-HBs, Anti-HBc, Anti-HBe, HBeAg, HBcIgM, and HBsAg for hepatitis B; and HCV Ab for hepatitis C.  

"The approval of our full hepatitis menu in the US is consistent with our strategy to address the hospital lab market, reinforcing our positioning as a supplier of both mainstream and specialty infectious diseases tests," said Chen Even, chief commercial officer of the DiaSorin Group.

"We are one of the only two vendors in the US to offer a complete hepatitis solution on a single platform, including a fully automated HBe antibody assay for the best patient management," Even said, adding, "We continue to be a leader in innovation with our HBsAg assay, which detects all genotypes, serotypes, and mutations for the most accurate diagnosis of HBV."