NEW YORK — Scope Fluidics said on Tuesday that it has obtained CE marking for its fully automated PCR One SARS-CoV-2 panel, developed by its subsidiary Curiosity Diagnostics, enabling its introduction to the European market.
PCR One is a multiplexed, sample-to-answer system with a 15-minute turnaround time, used for near-patient testing.
The certification of the first PCR One panels represents the culmination of nine years of work and is a good starting point for expanding a "portfolio of panels which verify the presence of many different pathogens in a single test in ultra-rapid time," Piotr Garstecki, CEO of Scope Fluidics, said in a statement.
Warsaw, Poland-based Scope Fluidics said many SARS-CoV-2 testing locations could benefit from the system’s performance, including medical centers and places frequented by the public.
The PCR One SARS-CoV-2 test demonstrated 91.2 percent sensitivity and 100 percent specificity in external hospital laboratories, the firm said. In an analysis of samples containing higher amounts of viral RNA from patients likely to infect others, PCR One showed 100 percent sensitivity and specificity, the firm said.
The system is designed to test for a number of targets in the SARS-CoV-2 genome and can be adapted to include targets to address the threat posed by new virus variants, the firm said.
At the end of 2020, the Polish National Centre for Research and Development awarded funding for the development of systems for rapid PCR detection of SARS-CoV-2 in addition to other viral infections causing similar symptoms, the firm noted.
In April, Scope Fluidics announced it had obtained the CE mark for its methicillin-resistant Staphylococcus aureus, or MRSA, assay on PCR One.