A Korean molecular diagnostic company, Gencurix, Inc., has announced that they have received U.S. Food and Drug Administration (FDA)’s Emergency Use Authorization (EUA) for its GenePro SARS-CoV-2 Test.

It is the second RT-PCR test that Gencurix has launched following the first test assay, GenePro COVID-19 Detection Test released last March. Key advantages of GenePro SARS-CoV-2 test include simultaneous monitoring of up to 384 samples which would allow High Throughput screening of the novel coronavirus. With the FDA’s EUA, Gencurix is now able to provide its COVID-19 detection tests in the U.S. nationwide.

Gencurix’s GenePro SARS-CoV-2 Test has the flexibility in the number of samples it can test simultaneously depending on the different PCR platforms. When most of the RT-PCR tests have been developed to be used with 96-well plates, GenePro SARS-CoV-2 test can be used with 384-well plate, which can quadruple the number of test samples. “According to a joint review with a CLIA lab in Salt Lake City, Utah, we found that you can test up to 6,000 people with just a couple of RNA prep and RT-PCR instruments.”, said Gencurix’s representative.

Another important advantage of the GenePro SARS-CoV-2 Test is the versatility of the RNA Extraction Kit. The lack of RNA Extraction Kit has become one of the biggest obstacles in carrying out coronavirus test in the U.S. Gencurix anticipates that it will be able to solve the problem as it has been approved with RNA Extraction Kits that are relatively well-supplied.

Gencurix is a molecular diagnostics company which has been developing and producing PCR(Polymerase Chain Reaction)-based diagnostic kits for many years in South Korea. Based on their accumulated R&D and development capabilities for diagnostic kits, Gencurix has been developing diagnostic products with better performance.

Their coronavirus diagnostic kits have been exported to various countries in Asia, North America, South America, Middle-East and Europe since April. As the number of confirmed cases of the coronavirus has been rising all over the world, they expect that their coronavirus test, which can be tested in large quantities, will draw attention.