Andyforce Receives Export Approval for COVID-19 Diagnostic Kits... Also Develops Rapid Diagnostic Kits

[Asia Economy Reporter Hyungsoo Park] AndyForce has received export approval from the Korea Food and Drug Administration for its novel coronavirus disease (COVID-19) diagnostic kit. The company is set to actively target overseas markets.

AndyForce announced on the 2nd that its COVID-19 molecular diagnostic kit, ‘ND COVID-19,’ has obtained export approval from the Ministry of Food and Drug Safety.

AndyForce’s diagnostic kit uses a real-time reverse transcription polymerase chain reaction (PCR) method that amplifies specific genes of COVID-19 (RdRp, E) to confirm infection within 2 hours. It enables accurate and rapid mass testing.

AndyForce secured COVID-19 positive and negative specimens and conducted clinical trials of the diagnostic kit, which demonstrated 99.9% sensitivity and specificity, earning validity recognition and export approval. Amid increasing demand for COVID-19 diagnostic kits, the company is also preparing to obtain European certification (CE).

AndyForce applied international standard specifications established by the International Organization for Standardization (ISO) to independently develop the ‘ND COVID-19 Detection Kit’ last month. It received approval for Good Manufacturing Practice (KGMP) and secured raw materials capable of production until the end of this year. The company has built a system to respond to the market demand for diagnostic kits increased by the global COVID-19 pandemic.

A company official said, "We are receiving many export requests for molecular and immunodiagnostic kits from overseas," adding, "Since we have both molecular and immunodiagnostic product lines, we plan to supply major countries after obtaining export approval for the immunodiagnostic kits."

The official also stated, "We plan to respond swiftly to the prolonged COVID-19 situation and the emergence of new viruses," and "through our overseas network, we have received inquiries related to diagnostic kits and are currently discussing export contracts with partners in Asia and Europe."

In addition to the molecular diagnostic kit that received export approval, AndyForce has developed a rapid diagnostic kit that can confirm COVID-19 infection within 10 minutes. The company is undergoing procedures to obtain export approval from the Ministry of Food and Drug Safety.

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