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PathoFinder Gets CE Mark for Second SARS-CoV-2 PCR Test

NEW YORK ─ PathoFinder said this week that it has obtained the CE-IVD mark for its RealAccurate Quadruplex SARS-CoV-2 PCR kit, allowing it to be marketed in the European Union and other countries that recognize the CE mark.

The RAQ SARS-CoV-2 PCR kit, which detects viral RNA from nasopharyngeal swabs, simultaneously targets the N gene and the RdRp gene of the virus, allowing for both viral detection and confirmation of positive results. The kit also allows replacement of a full nucleic acid extraction procedure with a simple heat treatment, which decreases sample processing time and saves on nucleic acid extraction reagents and disposables.

The molecular diagnostics firm, based in Maastricht, the Netherlands, had obtained CE marking in April for its RealAccurate Quadruplex Corona-plus PCR Kit, which detects both SARS-CoV-2 and MERS-CoV.