A Wageningen University spinoff life sciences company Scope Biosciences’s product, the eazySNP C. auris FKS1 S639, a CRISPR-based test developed with AmplexDiagnostics GmbH, is now CE marked under the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR).
The test uses Scope’s technology to detect mutations associated with antifungal resistance, marking the platform’s entry into regulated human diagnostics.
The assay detects mutations associated with resistance to echinocandins in Candida auris, a yeast that can cause severe infections and can be life threatening. Echinocandins are the recommended initial treatment for most C. auris infections but ineffective against the mutant, which does respond to alternative antifungal treatment. The test runs from a yeast colony on AmplexDiagnostics’ eazyMini instrument, delivering a result in approximately 45 minutes.
Scope’s platform combines isothermal DNA amplification with CRISPR detection to distinguish genetic sequences that differ by a single nucleotide. With eazySNP, that capability is incorporated into a clinical test on an existing diagnostic instrument.
“For Scope, eazySNP is an important step in that our propriety CRISPR type III technology is now part of a CE marked clinical test,” said Bas van der Baan, CEO of Scope Biosciences. “Working with Amplex shows how we can bring our detection technology into products with an established diagnostics manufacturer. We see further opportunities to work with partners on tests where simplicity, speed and molecular precision matter.”
Scope already applies its platform to on-site crop pathogen detection, with tests used by seed producers including Syngenta, KWS and Bejo. The Amplex collaboration extends its applications into human health, combining Scope’s detection technology with Amplex’s expertise in clinical diagnostics and regulatory requirements.
