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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.

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Oct
09
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.