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Bioneer Gets CE Mark for HBV Assay

NEW YORK — Bioneer said on Tuesday that it has received CE-IVD marking for its AccuPower hepatitis B virus quantitative PCR kit.

In late 2018, the South Korean company received CE-IVD marking for its AccurPower RT-PCR-based HIV-1 quantitative analysis kit, and about a year later, its AccuPower RT-PCR kit for hepatitis C was CE marked. All three kits run on the company's CE-marked ExiStation system. 

"With the certification of [our] HBV quantitative analysis kit, we have completed marking of all three major items of molecular diagnostics," Bioneer said in a statement. "Based on this, we will increase our participation in national bidding and accelerate expansion of distributors in overseas countries," such as those in Europe, Southeast Asia, and Africa, the firm added.

Bioneer noted that HIV, HBV, and HCV testing represents about two thirds of the world's $9.9 billion molecular diagnostics market.

Bioneer also recently submitted a Wuhan coronavirus diagnostic test kit for emergency use assessment and listing to the Korea Centers for Disease Control and Prevention.