CancerRop said that the Ministry of Food and Drug Safety has granted a manufacturing permit for Q-Sens® COVID 19 IgG/IgM Rapid Kit, its Covid-19 diagnostic kit.
The product is a kit that allows hospitals to visually check the test results in 10 minutes without a separate device by using immuno-chromatographic to detect specific antibodies produced immediately when infected with the Covid-19 virus.
In clinical trials with Myongji Hospital, the kit showed a sensitivity and specificity of 94 and 96 percent, respectively. The company expects to export the product to the global market, starting with the U.S., from July.
“The U.S. Food and Drug Administration approval process is also underway,” a CancerRop official said. “The company also plans to diversify its export countries to Southwest Asia, where the number of Covid-19 infected people is rapidly increasing.”
The company has a production capacity of more than 1 million vials per month. It will dramatically increase the production volume by expanding production facilities in the future, the official added.