Gencurix, a diagnostics biotech company, said it has won emergency use approval from the U.S. Food and Drug Administration for its Covid-19 test kit.
The recent nod will allow the Korean company to supply Covid-19 diagnostic kits to U.S. federal and state governments and all medical institutions.
|Gencurix’s Covid-19 test kit GenePro SARS-CoV-2 Test has won the FDA’s approval. (Gencurix)|
The test kit, “GenePro SARS-CoV-2 Test,” is an upgraded version of Gencurix’s existing Covid-19 detection kit by improving the convenience of examination.
It can test 384 samples in single testing, four times more than most other Covid-19 diagnostic kits, which can check up to 96 samples at a time.
When daily virus cases are exceeding 150,000, the demand for diagnostic kits capable of mass testing is growing, the company said.
The test capacity is vital because the polymerase chain reaction (PCR)-based test is highly accurate. However, it takes some time to extract ribonucleic acid from the samples and amplify it and see the result.
According to Gencurix, up to 6,000 samples can be tested a day in one laboratory with only a few required analytical equipment and automated system.
“Currently, ours is the only Covid-19 diagnostics kit that can test up to 384 samples at once,” a company official said. “Many customers have been waiting for the FDA to approve our product that can test in mass as the virus continues to spread, infecting more than two million people in the U.S.”
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