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DiaSorin Obtains CE Mark for High-Throughput Hepatitis E Antibody Assay

NEW YORK ─ DiaSorin on Tuesday announced that it has obtained the CE mark for its fully automated high-throughput Liaison Murex Anti-HEV IgG & IgM assay for the diagnosis of the hepatitis E virus, or HEV, and that it has launched the test in countries that accept the designation.

DiaSorin CEO Carlo Rosa said in a statement that the new test broadens the firm's offering for hepatitis and retrovirus diagnosis.

The company's fully automated Liaison hepatitis panel for the diagnosis of viral hepatitis ─ including hepatitis A, B, C, D, and E ─ speeds the time to treatment for people with or without hepatitis symptoms and helps in the monitoring of disease progression and treatment, DiaSorin said.

The Saluggia, Italy-based company noted that HEV infection is a major cause of acute hepatitis and about 20 million new infections occur annually.

Last month, it obtained US Food and Drug Administration Emergency Use Authorization for its Liaison SARS-CoV-2 TrimericS IgG test, a chemiluminescent immunoassay designed to detect immunoglobulin G against the coronavirus in serum and plasma.