Cancerorp Completes MFDS Export Approval and Clinical Trials for COVID-19 Test Kit... "Overseas Exports Begin"

[Asia Economy Reporter Hyunseok Yoo] Cancerop, a molecular diagnostic company specializing in genetic analysis, announced on the 12th that it has obtained European certification (CE-IVD) and export approval from the Ministry of Food and Drug Safety for its novel coronavirus (COVID-19) diagnostic kit, ‘Q-Sens 2019-nCoV Detection Kit.’

The Ministry of Food and Drug Safety, through the ‘Submission Materials for Export COVID-19 Diagnostic Reagent Approval Application’ announced on February 19, required clinical evaluation data for export approval of this COVID-19 diagnostic kit, unlike previous diagnostic kit export approvals. This export approval for COVID-19 diagnostic reagents is implemented with stricter requirements than the domestic emergency use authorization system, which only evaluated performance data from diagnostic reagent manufacturers.

A Cancerop official stated, “The strengthened export approval requirements for COVID-19 diagnostic kits appear to consider the international reliability of domestically produced diagnostic kits,” adding, “Cancerop’s diagnostic reagents underwent clinical evaluation to prove safety and efficacy at Myongji Hospital, a COVID-19 base hospital, and through considerable effort, excellent results were obtained. The Ministry of Food and Drug Safety recognized the validity of these clinical results, enabling us to obtain approval.”

He continued, “We produce the main raw materials such as diagnostic reagents in Cancerop’s KGMP (Korean Good Manufacturing Practice) production facility, so we are currently negotiating rapid export not only of diagnostic kits but also of raw materials.”

Cancerop completed the development of the diagnostic kit at the end of January and applied for emergency use authorization for infectious disease in vitro diagnostic products from the Korea Disease Control and Prevention Agency. After obtaining European CE certification, the company is currently discussing export contracts with partners in China, Southeast Asia, South Africa, and Europe for rapid commercialization.

The ‘Q-Sens 2019-nCoV Detection Kit’ developed by Cancerop increases diagnostic accuracy to 99.9% and reduces testing time to within 2 hours. It tests RNA extracted from samples such as sputum, nasopharyngeal swabs, and bronchoalveolar lavage fluid of suspected infected individuals using real-time reverse transcription polymerase chain reaction (RT-PCR).

Lee Wang-jun, CEO of Cancerop and director of Myongji Hospital, is serving as the head of the Korean Hospital Association’s COVID-19 Emergency Response Task Force. Myongji Hospital, which collaborates with Cancerop on immune therapy development, has discharged seven patients including cases 3, 17, and 28 during the early COVID-19 outbreak through a thorough infectious disease crisis response manual. The hospital operates as a nationally designated isolation negative pressure ward, regional emergency center, trauma center, and disaster base hospital, actively responding to the situation.

A company official said, “We will promptly respond to domestic demand as soon as the Korea Disease Control and Prevention Agency completes the emergency use authorization review process, simultaneously with overseas exports,” adding, “We are proceeding swiftly to prevent the spread of infection.”

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