IntronBio Obtains MFDS Approval for Pneumococcal Rapid Antigen Diagnostic Kit

[Asia Economy Reporter Hyungsoo Park] On the 9th, Intronbio announced that it has obtained official product approval from the Ministry of Food and Drug Safety (MFDS) for its rapidly developed rapid antigen diagnostic kit that detects antigens for Streptococcus pneumoniae (S. pneumoniae).

This is an in vitro diagnostic medical device that detects pneumococcal antigens present in human urine using the immunochromatography method. Clinical trials comparing the product with an FDA-approved product were conducted at Ajou University Hospital.

Pneumococcal diagnosis in hospitals mainly uses products approved by US authorities. These have the disadvantages of being expensive and inconvenient. Intronbio overcame these drawbacks by applying immunochromatography technology. Clinical trial results confirmed a sensitivity of 97.7% and specificity of 100% within 10 minutes.

The COVID-19 diagnostic kit recently approved by MFDS, developed by Intronbio's DR division, received approval based on molecular diagnostic technology applying the PCR method. The pneumococcal diagnostic kit is an MFDS-certified human diagnostic product using the immunochromatography method. Intronbio has obtained MFDS certification in both molecular diagnostics and immunochemical diagnostics, which form the two pillars of diagnostics.

Seol Jae-gu, Executive Director of Intronbio's DR Business Division, stated, "The Intronbio DR division will play an important role in expanding from animal diagnostics to the human molecular diagnostics market in the future," adding, "We will focus on targeting both domestic and overseas markets based on product reliability."

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