HONG KONG – Incheon, South Korea-based Celltrion Inc. is planning to launch two of its three rapid test kits in the U.S. as it plays its part in the global fight against the COVID-19 pandemic.
Celltrion said Aug. 12 that its Sampinute COVID-19 Antigen MIA and Diatrust COVID-19 IgG/IgM rapid test kits will launch in the U.S. by the third week of August. “[T]he number of kits to be sent to the U.S. is currently undetermined,” a Celltrion representative told BioWorld.
However, “[t]he need for more accessible, affordable and, most importantly, rapid diagnostic testing will grow as daily activities resume and the economy opens up again. … The two test kits’ quick turnaround time and sensitivity and specificity results will help health care providers to screen patients and keep communities safe,” the representative added.
The company is seeking the U.S. FDA’s emergency use authorization (EUA) for both kits, with an application lodged for the Diatrust COVID-19 IgG/IgM rapid test July 8 and the Sampinute COVID-19 Antigen MIA July 24.
The representative offered a further explanation for the company choosing the U.S. market. “[D]emand in the U.S., where there are still a huge number of cases, was deemed to be higher compared [with] other markets like Europe, where the case numbers are coming down as a whole.”
Of the almost 20.3 million global COVID-19 cases as of Aug. 12, the U.S. accounts for more than 5.1 million of them, according to Johns Hopkins University data. But with the company also filing applications for the kits’ CE certification, Celltrion is targeting markets beyond the U.S., the representative said.
Developed in collaboration with health care startup BBB Tech Inc., the Sampinute COVID-19 Antigen MIA is a point-of-care antigen test that detects the SARS-CoV-2 antigen from nasopharyngeal swab samples. The Diatrust COVID-19 IgG/IgM rapid test, developed with in vitro diagnostics developer Humasis, is a one-step in vitro diagnostic test based on an immunochromatographic assay.
The company said that it will launch second-generation rapid antibody and antigen diagnostic kits, also co-developed with Humasis using Celltrion’s proprietary COVID-19 antibody-antiviral technology to enhance detection sensitivity, in the second half of 2020.
Testing has proven to be a crucial tactic in Korea’s fight against COVID-19 since the country’s first outbreak in the southeastern city of Daegu in February. According to the Ministry of Health and Welfare, a total of 1,646,652 tests have been performed in Korea as of Aug. 12.
The Ministry of Food and Drug Safety (MFDS) approved the first urgent-use licenses for four companies March 10 and has since granted them to three more companies. It also has approved an additional nine kits for emergency use to screen COVID-19 emergency patients, with all nine able to provide results in less than an hour.
With that said, Korea has not been hoarding its testing capabilities. A MFDS blog said that 18 types of kits have been approved for export to more than 30 countries. One of these countries is Vietnam, currently fighting an outbreak that originated in the city of Da Nang in late July. It bought 200,000 tests from South Korea in March as it struggled to conduct widespread testing due to limited equipment and a lagging health care budget. But the country has since turned the tide, with its own test kit manufacturer, Viet A Corp., claiming to have exported 20,000 of its kits to eight countries in May. Viet A also said that it is in negotiations with 20 other countries.
U.S. President Donald Trump requested medical supplies, including test kits, during a March 23 phone call with Korean counterpart Moon Jae-in, according to the Blue House. During the call, Trump also promised to arrange FDA approval for the supplies on the same day.
Celltrion is also busy developing an antiviral antibody treatment for COVID-19. In August, CT-P59 received the U.K.’s Medicines and Healthcare Products Regulatory Agency’s approval to begin phase I trials, after MFDS approved an investigational new drug application on the back of positive preclinical results in July.
In addition to its contribution to the COVID-19 fight, the company is developing three biosimilars. These include a Xolair (omalizumab) biosimilar, CT-P39, for allergic asthma and chronic idiopathic urticaria indications, a Stelara (ustekinumab) biosimilar, CT-P43, to treat autoimmune diseases, and an Avastin (bevacizumab) biosimilar, CT-P16, to treat colorectal cancer, among other indications. Celltrion applied for EMA approval for CT-P17, its Humira (adalimumab) biosimilar also treating autoimmune diseases, in March and is currently preparing to apply for FDA approval.