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Bioneer Receives CE Mark for Coronavirus Kits, Inks Supply Agreement With Romania

NEW YORK – Bioneer said Thursday it has received CE marking for its AccuPower COVID-19 Real-Time RT-PCR Kit and AccuPower SARS-CoV-2 Real-Time RT-PCR Kit and has signed a $1.9 million agreement to supply its ExiStation molecular diagnostics system and coronavirus detection kits in Romania.

Under the terms of the supply agreement, Bioneer will distribute the ExiStation system and COVID-19 test kits to 20 hospitals selected by the Romanian Ministry of Public Health.

Financial and other terms of the agreement were not disclosed.

The COVID-19 test kits, distributed together, use the company’s Dual-HotStart PCR technology to detect RNA targets from clinical samples with high sensitivity and specificity by eliminating non-specific synthesis and amplification, Daejeon, South Korea-based Bioneer said.

The company's ExiStation performs RNA extraction and real-time PCR. It is equipped with an automated system to enable quick and accurate results and can be expanded and configured according to the size of the laboratory, the number of specimens, and the type of inspection, the firm said.