Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Another Resignation

According to the Wall Street Journal, a third advisory panel member has resigned following the US Food and Drug Administration's approval of an Alzheimer's disease drug.

Novavax Finds Its Vaccine Effective

Reuters reports Novavax's SARS-CoV-2 vaccine is more than 90 percent effective in preventing COVID-19.

Can't Be Used

The US Food and Drug Administration says millions of vaccine doses made at an embattled manufacturing facility cannot be used, the New York Times reports.

PLOS Papers on Frozen Shoulder GWAS, Epstein-Barr Effects on Immune Cell Epigenetics, More

In PLOS this week: genome-wide association study of frozen shoulder, epigenetic patterns of Epstein-Barr-infected B lymphocyte cells, and more.