Zepto Life Technology received US FDA breakthrough device designation for its FungiFlex Mold Panel aimed at invasive mold infections. The assay detects and distinguishes fungal cell-free DNA directly from plasma, targeting clinically relevant species across Aspergillus, Mucorales, Fusarium, and Scedosporium/Lomentospora. The company said the approach is designed to reduce the diagnostic lag that often forces treatment decisions without knowing the organism. Zepto plans to make the test available to clinicians as a laboratory-developed test through its CLIA lab in St. Paul, Minnesota, leveraging its proprietary GMR biosensor technology and Zepto MDx platform.