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Scope Fluidics Gets CE Mark for Rapid MRSA MDx Panel

NEW YORK – Polish molecular diagnostics maker Scope Fluidics said on Friday that it has obtained the CE mark for its methicillin-resistant Staphylococcus aureus (MRSA) assay on its rapid molecular system, called PCR One.

The assay detects a panel of bacterial targets. The PCR One system performs rapid 40-cycle thermal cycling and detects up to 20 targets in parallel, with patient swabs placed directly into a microfluidic cartridge and results reported in less than 15 minutes.

The CE mark for the MRSA panel "is important in the development of PCR One, which the Scope Fluidics team has been developing since 2012," said CEO Piotr Garstecki in a statement.

The firm noted that it expects to introduce the new assay as part of an early-access program and will also pursue CE-IVD certification for a SARS-CoV-2 panel, as previously described.

"The exceptional functionality of the PCR One system, protected by patents in the US, EU, and China, is of particular practical and economic value in the era of the COVID-19 pandemic," said Carl Wittwer, cofounder of BioFire Diagnostics and a member of Scope Fluidics' advisory board.

Since February of 2020, Scope Fluidics has raised approximately $9 million and secured a loan of up to $12 million from the European Investment Bank.