Zepto Life Technologies received FDA breakthrough device designation for its FungiFlex Mold Panel, a plasma-based assay designed to detect circulating cell-free DNA from invasive fungal pathogens. The test is intended to identify clinically relevant molds directly from blood, targeting genera including Aspergillus, Mucorales, Fusarium, and Scedosporium/Lomentospora. Zepto will initially offer the panel to clinicians as a laboratory-developed test from its CLIA lab in St. Paul, Minnesota. The company said the approach could reduce diagnostic delays by providing organism-level information without requiring clinicians to stitch together multiple disparate modalities. Diagnosing invasive fungal infections often depends on combinations of imaging, microbiology, histopathology, and serology, which can leave treatment decisions without definitive organism identification. Zepto’s claim is that targeted liquid biopsy can improve speed and decision-making by detecting fungal cfDNA in plasma. The designation reinforces FDA interest in faster, blood-based diagnostics for high-acuity infectious disease settings, where earlier targeted therapy can be decisive.