Humasis Receives Export Approval for COVID-19 Molecular Diagnostic Reagents

[Asia Economy Reporter Ji-hwan Park] Humasis, a field-type rapid testing specialist company, announced on the 15th that it has developed a molecular diagnostic reagent for detecting COVID-19 and received export approval from the Ministry of Food and Drug Safety.

This approval was granted on the 9th for Humasis's reagent product, the ‘Humasis COVID-19 RT-qPCR Kit’. This reagent can only determine whether the COVID-19 virus is confirmed positive. Based on this, the company has also developed a molecular diagnostic reagent capable of detecting the Omicron variant and is currently conducting clinical trials.

Humasis has expanded its business area from the existing immunodiagnostic business to a molecular diagnostic platform based on this molecular diagnostic reagent. In particular, the company plans to expand the molecular diagnostic field to cover all infectious diseases in the future.

A Humasis official stated, "By developing molecular diagnostic-related products alongside our existing immunodiagnostic products, we are building a model for broader business expansion," and added, "We plan to increase investment in researchers and production facilities to establish a lineup of molecular diagnostic reagent products."

Humasis currently holds domestic official approval for two products: the professional rapid antigen diagnostic kit ‘Humasis COVID-19 Ag Test’ and the personal self-test kit ‘Humasis COVID-19 Home Test’.

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