AmplexDiagnostics has launched a CE-IVD molecular diagnostic test that detects a genetic mutation associated with antifungal resistance in Candidozyma auris, a multidrug-resistant yeast pathogen.

The eazySNP C. auris FKS1 S639 test combines loop-mediated isothermal amplification (LAMP) with CRISPR technology to identify a resistance-associated mutation in the FKS1 gene. The assay delivers results within 45 minutes when performed directly from a yeast colony using the company’s eazyMini platform.

The test was developed through a collaboration between AmplexDiagnostics and Scope Biosciences, which supplied the CRISPR technology. The launch also marks Scope Biosciences’ expansion from plant health diagnostics into human molecular diagnostics.

Detecting antifungal resistance

C. auris can cause serious infections, particularly in healthcare settings, and is a concern because of its ability to resist multiple antifungal medicines. Echinocandins are a first-line treatment option for many C. auris infections, making the early identification of resistance clinically important.

The eazySNP assay targets the FKS1 S639 mutation, which is associated with echinocandin resistance. Identifying this genetic variant could help laboratories detect a resistance marker more rapidly than methods that require additional testing steps.

The assay combines LAMP, which amplifies genetic material at a constant temperature, with CRISPR-based detection designed to recognise a specific genetic sequence. This approach is intended to provide targeted detection of single-nucleotide variants, which are changes affecting a single DNA building block.

However, the launch announcement does not include sensitivity or specificity figures, clinical validation results, or a direct comparison with existing diagnostic methods. Further performance data would be needed to establish how the assay compares with current laboratory testing and how its results could influence treatment decisions.

CRISPR technology enters human diagnostics

For Scope Biosciences, the product provides a route to applying its CRISPR technology in a regulated human diagnostic test.

Bas van der Baan, CEO of Scope Biosciences, said: “This launch is an important milestone for Scope Biosciences: our CRISPR technology has moved from a versatile platform to a regulated product that addresses a concrete diagnostic need.”

He added: “Together with AmplexDiagnostics, we have translated single-nucleotide precision into a practical assay for routine laboratories. It marks our entry into human diagnostics while we continue expanding our portfolio for plant health.”

The collaboration brings together CRISPR-based genetic detection and AmplexDiagnostics’ molecular testing platform. The companies say the combination enables rapid and specific detection of genetic variants, with the first product focused on antifungal resistance in C. auris.

The CE-IVD designation indicates that the test is being placed on the European market as an in vitro diagnostic under the applicable conformity framework. The announcement does not provide further details of the regulatory documentation or the clinical evidence supporting the product’s performance.

The launch establishes a new application for the combined LAMP and CRISPR approach. Its clinical significance will depend on the assay’s demonstrated accuracy, its performance in routine laboratory settings and whether faster detection can support timely treatment decisions for patients with resistant infections.