Cancerorp Applies for US FDA Approval of COVID-19 Diagnostic Kit

[Asia Economy Reporter Jang Hyowon] Cancerop, a molecular diagnostics company specializing in genetic analysis, announced on the 27th that it has applied for approval of the ‘Q-Sens 2019-nCoV Detection Kit’ from the U.S. Food and Drug Administration (FDA).

The ‘Q-Sens 2019-nCoV Detection Kit’ is a diagnostic kit for the novel coronavirus infection (COVID-19) developed by Cancerop. 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). It is explained that the kit has the advantage of a high diagnostic accuracy of 99.9% while reducing the testing time to within 2 hours.

It has received European certification (CE-IVD) and obtained export approval from the Ministry of Food and Drug Safety on the 11th of this month. Cancerop produces main raw materials such as diagnostic reagents in its own KGMP (Korean Good Manufacturing Practice) production facility, and plans to export not only diagnostic kits but also raw materials.

A company official stated, “We applied to the FDA on the 24th and the approval review process is currently underway,” adding, “Given the urgent situation, we expect approval to be granted quickly.”

He further added, “Since the registration number has already been issued, we are in a position to receive orders from medical institutions in the United States.”