CancerRop, a molecular diagnostics company, said it obtained approval for a Covid-19 diagnostic kit, “Q-Sens® COVID-19 Detection Kit,” from the Ministry of Food and Drug Safety on Thursday.

The authorized test kit uses a reverse transcription-polymerase chain reaction (RT-PCR) technique to detect the Covid-19 virus by separating and amplifying the virus's genes from a patient's respiratory sample.

“We obtained excellent results of the diagnostic reagent from a clinical performance test at Myongji Hospital, one of the institutions for Covid-19 treatment,” an official at CancerRop said. “As we are producing the main ingredient at our GMP (Good Manufacturing Practice) manufacturing site, we have stable quality control and price competitiveness.”

Also, CancerRop has developed an additional genetic diagnostic reagent with better performance, accuracy, user convenience, and price competitiveness, the official went on to say. The company completed the clinical performance test recently, seeking regulatory approval from the ministry.

The second test kit is expected to provide a stable supply for the local market amid concerns over a second outbreak of the Covid-19 pandemic, the official added.

Earlier, CancerRop received the export license for the Covid-19 diagnostic kit and an antibody diagnostic reagent.