Diasorin (FTSE MIB: DIA) announced today it has secured U.S. Food and Drug Administration (FDA) De Novo authorization for the first fully automated diagnostic test for hepatitis delta virus (HDV) on the Diasorin LIAISON XL immunoassay system. Designated as a Breakthrough Device by the FDA, the test aids in the diagnosis of HDV in individuals living with acute and chronic hepatitis B virus (HBV). The development of the automated diagnostic assay has been supported by Gilead Sciences.

On 10 July 2025, the World Health Organization (WHO) prequalified the first bundled set of three in vitro rapid diagnostic tests (RDTs) capable of simultaneously detecting HIV, hepatitis B virus (HBV) and syphilis – three major infections that pose serious risks to maternal and child health.

Cepheid announced recently it has received CE-IVD clearance for a rapid molecular assay to measure viral load of hepatitis B in infected patients. The Xpert HBV Viral Load test measures HBV DNA levels in plasma or serum using the firms Gene