DiaSorin announced that it has received FDA approval for six Hepatitis B assays, completing the company’s product line in the United States, according to a press release.
With this approval, DiaSorin said it now offers a complete testing solution for Hepatitis A (HAV total, HAV IgM), Hepatitis B (Anti-HBs, Anti-HBc, Anti-HBe,HBeAg, HBcIgM, and HBsAg), and Hepatitis C (HCV Ab) in the U.S. market.
HBV is a vaccine-preventable liver infection. For some people, it is an acute or short-term illness, but for some others it can become a long-term chronic infection, which leads to serious health issues, like cirrhosis or liver cancer. HBV infection represents the third leading cause of death due to liver cancer.
In the United States, the number of reported acute hepatitis B cases has remained stable, with around 20,000 new cases per year, with a total of 900,000 people living with HBV. However, low vaccination rates for hepatitis B among adults and increasing rates of injection drug use are fueling a rise in acute HBV infections in the United States, and the Centers for Disease Control and Prevention estimates that half of the people with chronic HBV infection do not know they are infected, according to DiaSorin.
The approval of the Hepatitis B panel falls within the agreement signed with Beckman Coulter in 2016, when the two organizations formed a strategic partnership to bring the LIAISON XL Hepatitis and HIV products to the U.S. market. Since then, the companies have been working to secure FDA approval and commercialization in the U.S. of the full line of Hepatitis (A, B, C) and HIV assays, which are already available to DiaSorin customers outside the United States.
