The FDA granted Zepto Life Technology breakthrough device designation for its FungiFlex Mold Panel, a blood-based diagnostic that aims to detect and distinguish circulating cell-free DNA from invasive mold infections. The panel is designed to identify clinically relevant fungi across Aspergillus, Mucorales, Fusarium, and Scedosporium/Lomentospora species. Zepto Life is offering the test to clinicians as a laboratory-developed test at its CLIA lab in St. Paul, Minnesota. The company said direct-from-blood cfDNA testing could help clinicians choose targeted antifungal therapy sooner when imaging and conventional lab workflows fail to clarify the organism quickly. Zepto Life’s platform uses giant magnetoresistance biosensor technology, and it competes in a crowded space where other direct-detection approaches aim to shorten the time to organism identification.