Celltrion announced on Nov. 2 that Celltrion USA, Celltrion’s US subsidiary, has signed a contract to supply COVID-19 diagnostic kits to the U.S. market.
Celltrion signed a large-scale contract after obtaining the emergency use approval (EUA) from the U.S. Food and Drug Administration (FDA) for the COVID-19 antigen rapid diagnostic kit 'Sampinute'.
Celltrion USA signed this contract with 'Prime Healthcare Distributors', who is a leading national wholesale distributor in healthcare, hospitality, and government procurement services specializing in diagnostic products and personal protective equipment throughout the United States.
Prime Healthcare Distributors, will be an exclusive distributor of the Sampinute COVID-19 Antigen Rapid Test throughout the U.S. market.
Sampinute is a COVID-19 antigen rapid diagnostic kit that increases sensitivity by incorporating its proprietary COVID-19 antibody-antigen technology, and allows health professionals to obtain results in 10 minutes using a portable professional equipment, and it is jointly developed with BBB, a South Korea diagnostic device manufacturer.
In particular, it is characterized in having the highest sensitivity among rapid COVID-19 diagnostic devices by showing a sensitivity higher than 94% when compared to the existing RT-PCR (reverse transcription polymerase chain reaction) method.
"Celltrion has recently completed the FDA emergency use authorization and concluded this large-scale contract after launching the Sampinute in August under the judgment that the market demand in the United States is high, where the number of new COVID-19 confirmed cases is rapidly increasing," a Celltrion representative stated. "Based on the current development status and the release of follow-up products that are subject to EUA application, we will do our best to maximize the global COVID-19 preventive measures by supplying diagnostic kits not only in the U.S. but also in countries where the spread of COVID-19 is prominent."
According to a report released in September by the market research organization Grand View Research, the global COVID-19 diagnostic device market is expected to reach $19.8 billion this year and about 22.4 trillion Korean won (KRW).
