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PathoFinder Obtains CE Mark for Two Multiplex SARS-CoV-2 MDx Tests

NEW YORK – Dutch molecular diagnostics developer PathoFinder has received CE IVD marking for two multiplex PCR tests for SARS-CoV-2 and other respiratory pathogens.

Specifically, the Maastricht-based firm obtained CE marking for the RespiFinder 2Smart kit for SARS-CoV-2 and Middle East respiratory syndrome-related coronavirus (MERS-CoV) testing, as well as for the RealAccurate Quadriplex (RAQ) Flu/COVID-19 PCR kit.

PathoFinder said that the RespiFinder 2Smart kit now detects 24 respiratory pathogens simultaneously using the company's proprietary 2SmartFinder technology. The SARS-CoV-2 N gene and MERS-CoV E gene were selected as targets to detect these additional viruses.

Meanwhile, the RAQ Flu/COVID-19 PCR kit detects and differentiates influenza A, influenza B, and SARS-CoV-2 (using the N gene and RdRp gene) from nasopharyngeal swabs.

PathoFinder received CE marking in April for its RealAccurate Quadruplex Corona-plus PCR kit for detecting SARS-CoV-2 from nasopharyngeal and oropharyngeal swabs, and in June for its RealAccurate Quadruplex SARS-CoV-2 PCR kit for detecting viral RNA by targeting the N and RdRp genes.