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Genomtec Gets CE-IVD Mark for Saliva-Based Molecular SARS-CoV-2 Test

NEW YORK — Polish diagnostics firm Genomtec said on Monday that it has received CE-IVD marking for its saliva-based SARS-Cov-2 EvaGreen Direct-RT-LAMP Kit.

According to Genomtec, based in Wroclaw, the test is designed to detect the SARS-CoV-2 S and N genes in saliva samples. It does not require nucleic acid purification and can provide results in several minutes. The test is currently offered through Dolnośląskie Centrum Medyczne in Wroclaw, a reference lab for Genomtec's products. It is compatible with standard RT-PCR instrumentation, the company added.

"By elimination of the laboratory nucleic acid purification stage from biological material, we have shortened the processing time and simplified the entire diagnostic process, which also reduces its cost of labor," Miron Tokarski, Genomtec's cofounder and president, said in a statement. "Our new genetic tests from saliva will be able to increase the laboratories' diagnostic throughput by several times."

Genomtec has also been developing a new testing platform, to be launched later this year. In 2019, the company received a $2.4 million grant from Poland's National Center for Research and Development to support its development of a handheld molecular diagnostic testing device and accompanying respiratory disease panel.