Zepto Life Technology’s invasive mould detection test has secured a breakthrough device designation from the US Food and Drug Administration (FDA).

The Minnesota-based company’s FungiFlex Mold Panel is a liquid biopsy test designed to aid in the diagnosis of invasive mould infections through the detection and identification of fungal cell-free DNA directly from plasma.

Developed using Zepto’s proprietary Giant Magnetoresistance (GMR) biosensor technology, FungiFlex is designed to detect fungal cell-free DNA (cfDNA) circulating in plasma. The assay is capable of identifying 14 clinically relevant mould pathogens, including Aspergillus, Mucorales, Fusarium, and Scedosporium/Lomentospora.