Andyforce obtains European CE certification for 'COVID-19' diagnostic kit... "Pursuing US FDA emergency use authorization"

[Asia Economy Reporter Hyunseok Yoo] AndyForce announced on the 3rd that it has obtained the European CE certification for its molecular diagnostic kit for COVID-19, ‘ND COVID-19’. Starting with this CE certification, AndyForce will be able to export the COVID-19 molecular diagnostic kit not only to Europe but also to most countries worldwide that recognize the European CE certification. Following the CE certification, the company also plans to pursue the Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

The molecular diagnostic kit certified this time uses the real-time reverse transcription polymerase chain reaction (Real-time RT-PCR) method to amplify specific genes of the novel coronavirus, ‘RdRp, E’, enabling confirmation of COVID-19 infection within 2 hours, allowing for rapid mass testing.

After successfully developing the COVID-19 molecular diagnostic kit last month, AndyForce obtained the International Organization for Standardization (ISO) medical device quality management system certification (ISO 13485) to meet the increasingly stringent international quality requirements. To prepare for the growing overseas demand for diagnostic kits, the company has already secured raw materials capable of production through the end of this year. Since preparations for overseas market entry have been made without any setbacks, shipment of export volumes following certification completion is now possible.

An AndyForce official stated, “Inquiries about molecular and immunodiagnostic kits are rapidly increasing through the overseas networks currently held by the company,” adding, “Especially, partners in Europe and Asia are negotiating export prices and volumes, so this European CE certification will give a significant boost to overseas market expansion.”

He continued, “We are in consultation with Professor Roger Kornberg, an internal director of AndyForce, to obtain the Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA),” and added, “With this CE certification, we will establish an emergency pharmaceutical production system to actively respond to the demand for diagnostic kits.”

Meanwhile, in addition to the molecular diagnostic kit that received the European CE certification, AndyForce has completed the development of a rapid diagnostic kit that can confirm COVID-19 infection within 10 minutes and is currently proceeding with export approval from the Ministry of Food and Drug Safety and European CE certification.

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