Skip to main content
Premium Trial:

Request an Annual Quote

Scope Fluidics Obtains CE Mark for PCR-Based SARS-CoV-2 Panel

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.

The Scan

Booster for At-Risk

The New York Times reports that the US Food and Drug Administration has authorized a third dose of the Pfizer-BioNTech SARS-CoV-2 vaccine for people over 65 or at increased risk.

Preprints OK to Mention Again

Nature News reports the Australian Research Council has changed its new policy and now allows preprints to be cited in grant applications.

Hundreds of Millions More to Share

The US plans to purchase and donate 500 million additional SARS-CoV-2 vaccine doses, according to the Washington Post.

Nature Papers Examine Molecular Program Differences Influencing Neural Cells, Population History of Polynesia

In Nature this week: changes in molecular program during embryonic development leads to different neural cell types, and more.