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Roche Nabs CE Mark for Hepatitis C Antigen/Antibody Test

NEW YORK – Roche announced on Monday that its Elecsys HCV Duo test for hepatitis C virus (HCV) received CE marking, and it is launching in countries accepting the regulatory approval.

The test allows for the simultaneous determination of a patient's HCV antigen and antibody status from a serum or plasma sample. The HCV core antigen appears early in the course of infection and is a marker of ongoing viral replication, the Basel, Switzerland-based firm said in a statement.

By detecting both the antigen and antibody status, the assay can be used to detect early stages of infection or when a patient is recovering from the virus. It can also be used to determine if a patient is showing signs of a chronic infection that could lead to another disease, the company said.

"With improved hepatitis screening, healthcare systems have the opportunity to eliminate the disease through improved prevention, testing, and treatment services," Roche Diagnostics CEO Thomas Schinecker said in a statement. "The addition of the Elecsys HCV Duo assay to our HCV testing portfolio can help in the fight to eliminate the hepatitis C virus."