South Korean biopharma company has got emergency use approval (EUA) from the US authorities for its rapid test Sampinute that has an accuracy rate of 94% and a turnaround time of 10 minutes. It has another rapid test in the pipeline awaiting EUA, which can be used in a clinical setting.
Celltrion, a South Korean biopharmaceutical company, confirmed Monday that it had received emergency use authorization (EUA) from the U.S. Food & Drug Administration (FDA) for its rapid COVID-19 testing kit Sampinute.
The announcement boosted shares of the company and its affiliates
The Sampinute test by Celltrion can give test results in 10 minutes with a sensitivity of around 94%.
The company applied for approval in late July. The kit has already been launched in the United States in August, states the company.
“(The company) is planning to supply Sampinute across the United States through local wholesalers as it believes the demand for rapid diagnosis kits will be high, mainly among large businesses and government agencies that are about to return to work after telecommuting,” it said in a statement.
Celltrion USA, Inc., the US subsidiary of Celltrion, and exclusive distributor of Celltrion’s small molecule and other injectable products will be marketing the test kits.
Sampinutetm covid-19 antigen MIA is an electrochemical immunoassay test for detecting SARS-CoV-2 antigen from nasopharyngeal swab samples, and uses one-time test cartridges and a portable analyzer.
Celltrion has developed another rapid test called the DiaTrustTM COVID-19 IgG/IgM which shows reliable performance with 96% positive percent agreement. This test is a one-step in-vitro diagnostic one based on immunochromatographic assay designed for rapid detection of antibodies of the coronavirus in healthcare settings in collaboration with Humasis. The test can give results in 15 minutes. It is still awaiting FDA approval.
“Celltrion has been striving to bring the tests into the US. The need for more accessible, affordable, and most importantly, rapid diagnostic testing will grow, as the daily activities are coming back, and the economy is opening up again,” a Celltrion representative stated. “With the short turnaround time and promising performance of the sensitivity and specificity results, Celltrion is confident that both SAMPINUTETM COVID-19 Antigen MIA and DiaTrustTM COVID-19 IgG/IgM Rapid Test will add great value to healthcare providers in screening patients and keeping communities safe."
Shares of Celltrion Inc surged as much as 4.6%, while Celltrion Pharm 068760.KQ and Celltrion Healthcare 091990.KQ jumped 4.6% and 1.6%, respectively. Broader KOSPI.KS11, however, was trading down 0.1% as of 0208 GMT, according to a Reuters report.
Celltrion Inc has also received approval for Phase 3 clinical trials for an experimental treatment for COVID-19, called the antibody-drug CT-P59. This drug targets the surface of the virus and blocks it from attaching to human cells. The third stage trials will be done on 1,000 asymptomatic COVID-19 patients as well as those who have come into close contact with them.