Celltrion will proceed with the application process for permission to sell COVID-19 diagnostic kit products that it developed with domestic diagnostic kit companies and release them in the U.S. market from Aug. 12.
Since February, Celltrion has been working closely with related domestic companies to commercialize diagnostic kits that can meet global market demand, and has recently completed product development with partner companies and taken certification and licensing procedures to launch products in overseas markets.
In cooperation with BBB, a company specializing in diagnostic devices, Celltrion developed a high-sensitive antigen diagnostic kit, called "SampinuteTM," which can increase sensitivity and check the results within 10 minutes by incorporating its own COVID-19 antibody-antigen technology, and will first start selling it in the U.S. market after applying for approval for emergency use to the U.S. FDA.
The POCT is more sensitive than the RDT (rapid diagnostic kit) that can be visually identified with a diagnostic device that can examine samples immediately at the site of the medical treatment using portable equipment and check the results.
SampinuteTM is an antigen diagnostic kit that can select patients in the early stages of infection where antibodies have not been formed, and it also provides speed at the level of existing rapid diagnosis kits and high sensitivity at the level of molecular diagnosis.
It shows a higher sensitivity of 95 percent or more compared to RT-PCR in 10 minutes, making it the highest level of completion among products related to COVID-19.
The strategy is to predict that demand for "SampinuteTM" will be high mainly for large companies and government agencies that have finished long-term home work and are about to return to work, and to provide the kits mainly through large local drug wholesalers, and to respond to some large demanders in the form of direct contracts.
DiaTrustTM – high efficiency antibody diagnostic kit
Celltrion will also apply for FDA approval for the COVID-19 antibody rapid diagnostic kit (RDT) "DiaTrustTM" developed with Humasis, a specialized diagnostic kit company, and will start selling it in the U.S.
Antibody RDT can easily be examined for a large number of patients at a low cost and is also widely used in medical institutions to confirm the discharge of completely cured patients because it shows sensitivity one week after the onset of antibody formation.
Since it believes that antibody RDT can play a complementary role with antigen POCT, it plans to actively promote the sale of 'DiaTrustTM' in the form of a package bundled with antigen POCT 'SampinuteTM' to maximize its merchantability.
In addition, as the incident rate of COVID-19 patients in the U.S. is still at a serious level and the pandemics are showing signs of prolongation, it plans to explore the possibility of supplying 'DiaTrustTM' for use at home, like first aid kits, for use by locals at all times.
"The efforts to develop the COVID-19 diagnostic kit have paid off with the launch of it in the U.S. market, the world's largest medical market," said an official of Celltrion.
