MiCo BioMed, a leading in vitro diagnostic (IVD) company in South Korea and Celltrion, another South Korean biopharmaceutical firm have announced on the 28th that they have earned a CE marking for their co-developed COVID-19 neutralizing antibody ELISA diagnostic kits under two different brands : Veri-Q (MiCo BioMed brand) and TekiTrust (Celltrion OEM brand) The two companies have obtained the approval by establishing a collaborative system for product research and development, and they plan to accelerate the commercialization of the new product. Mico Biomed will be in charge of manufacturing of finished products and Celltrion, marketing and sales.
COVID-19 neutralizing antibody ELISA diagnostic kits is a product jointly developed, based on ELISA biotechnology of MiCo BioMed and with raw materials (antibody and antigen) provided by Celltrion. The new diagnostic kits, with 94.4% clinical sensitivity and 100.0% specificity, can quantify the potency (effect) of neutralizing antibody of COVID-19 by means of an enzyme-linked immunosorbent assay (ELISA). ELISA is an immunodiagnostic method of detecting antigen-antibody reaction by binding a chromogenic enzyme to an antigen or an antibody. Since it is a cost-effective and allows large scale diagnostic testing, ELISA is one of the most commonly used
As the worldwide COVID-19 vaccination efforts accelerate, so does the demand for large-scale testing to check whether neutralizing antibodies have formed in those who have been vaccinated. Formation of neutralizing antibodies, which literally neutralize COVID-19 virus, is key indicator to check the vaccine efficacy. In the US, adult vaccination coverage is up to 40%. Such high vaccination rate is one of the reasons the two companies set their target market in North America. Additionally, only one US Company has obtained FDA EUA for the neutralizing antibody ELISA kit so far. MiCo BioMed and Celltrion plan to quickly complete the FDA EUA approval process through Celltrion's US subsidiary and initiate business operation in hospitals and clinical centers across the US.
Meanwhile MiCo BioMed is going through IRB approval process for domestic sales of COVID-19 self-diagnostic antibodies (IgG/IgM) rapid detection kits and looking forward to carry out clinical trials soon.