FDA Grants De Novo Authorization to DiaSorin for Automated Hepatitis Delta Virus Test

Reuters14:05
FDA Grants De Novo Authorization to DiaSorin for Automated Hepatitis Delta Virus Test

DiaSorin S.p.A. has received U.S. Food and Drug Administration (FDA) De Novo authorization for its LIAISON XL murex anti-HDV Assay, the first fully automated laboratory test for Hepatitis Delta Virus $(HDV)$ in the United States. The immunoassay, developed with support from Gilead Sciences, addresses a significant gap in FDA-cleared testing for individuals with acute or chronic Hepatitis B (HBV) who are at risk for developing active HDV infection. The test is available in the United States starting February 2026 and aims to improve patient identification and clinical management of HDV co-infection.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. DiaSorin S.p.A. published the original content used to generate this news brief on January 29, 2026, and is solely responsible for the information contained therein.

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