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Bioneer Gets CE Mark for HCV Assay

NEW YORK – A real-time PCR assay from Bioneer to detect hepatitis C virus has received the CE mark, the firm said on Thursday.

The AccuPower HCV Quantitative RT-PCR Kit quantifies HCV viral RNA from blood samples using Bioneer's semi-automated real-time qPCR molecular diagnostic system, called ExiStation, which is CE marked and therefore eligible for procurement under World Health Organization criteria, the firm said.

Bioneer noted in a statement that registration for the HCV kit now "accelerates the global growth of the company," allowing it to enter into new markets and meet new target customers, including major hospitals and healthcare centers.

Specifically, the Daejeon, South Korea-based molecular diagnostics maker said it is planning to enter the European market and the international procurement market.

Bioneer received its first CE mark for an assay – its AccuPower HIV-1 Quantitative RT-PCR Kit – last year. That test also received approval from the Ministry of Food and Drug Safety, a division of the Korea Food and Drug Administration, earlier this year. The firm also has a multiplex test for three mosquito-borne viruses that is eligible for WHO procurement, and it is planning to seek CE mark for an HBV test in the near term.