[Infostock Daily = Reporter Kim Jong Hyo] Celltrion will launch a license application process for local sales of COVID-19 diagnostic kit products developed in cooperation with domestic diagnostic kit companies and launch them in the U.S. market from the 12th.
Since February, Celltrion has been working closely with the related domestic industry to commercialize diagnostic kits that have differentiated quality competitiveness and meet global market demand in pandemic situations. In recent years, the company has completed product development with partner companies and has been accredited and licensed for overseas market launches.
According to Celltrion, through cooperation with BBB, a diagnostic device company, Celltrion's own COVID-19 antibody-antigen technology will be combined to increase sensitivity and develop the antigen POCT product 'SampinuteTM', which can confirm the results within 10 minutes and start selling it in the U.S. market first after applying for approval for emergency use by the U.S. FDA.
This is because they judged that market demand in the U.S., where large-scale confirmed cases are coming out every day, is higher than in European countries, where the pandemics are on a easing trend.
POCT is a diagnostic device that can check samples immediately at the medical site using portable equipment and check the results. It is characterized by a good sensitivity compared to RDT(fast diagnosis kit) that is visually identified.
SampinuteTM, which Celltrion co-developed with BBB, is an antigen diagnostic kit that can select early patients with infections without antibody formation, and provides rapidity at the level of existing rapid diagnosis kits and high sensitivity at the level of molecular diagnosis.
Reporter Kim Jong Hyo firstname.lastname@example.org