MicoBio Obtains Pre-Sales Approval for COVID-19 Diagnostic Kit Before US FDA EUA Approval

[Asia Economy Reporter Hyunseok Yoo] Bio medical diagnostic company Mico BioMed announced on the 22nd that it has obtained FDA notification to distribute prior to EUA authorization from the US FDA for its COVID-19 diagnostic kits.

The products authorized for distribution are two types of molecular diagnostic test kits that can determine COVID-19 infection status. One is a closed kit that performs rapid molecular diagnosis using the company’s own ‘Veri-Q’ gene extraction and amplification equipment. The other is an open kit that uses universal equipment for molecular diagnosis. The company is now able to sell both kits, compatible with either proprietary or universal equipment, within the United States.

With the ability to sell COVID-19 diagnostic kits in the US market, Mico BioMed plans to rapidly promote sales through direct and indirect sales strategies. It is expected to achieve steep revenue growth through exports to the US via its US subsidiary MiCo BioMed USA and overseas agencies, while also securing a favorable position to expand export scope to other global countries.

Meanwhile, Mico BioMed applied for emergency use authorization for a one-hour COVID-19 gene test reagent to the Korea Disease Control and Prevention Agency on June 1 and is awaiting the results.

Currently, Mico BioMed has filed a preliminary review for transfer listing on KOSDAQ and is awaiting final approval. The company aims to be listed on KOSDAQ within the third quarter.

This content was produced with the assistance of AI translation services.