Zepto Life Technology received FDA breakthrough device designation for its FungiFlex Mold Panel, a plasma-based assay designed to detect invasive mold infections via circulating cell-free DNA. The panel distinguishes among clinically relevant mold groups including Aspergillus and other major species complexes, with the goal of enabling faster, more targeted treatment decisions. Zepto said clinicians often face delays because diagnosis typically requires combining imaging, microbiology, histopathology, and serology—each of which can be slow or inconsistent early in disease. By shifting to a liquid-biopsy approach, the company positions the panel as a way to narrow pathogen identification sooner. The test is already available as a laboratory-developed test through Zepto’s CLIA lab. Breakthrough status can accelerate development and interaction with FDA and may influence subsequent reimbursement discussions. The designation also signals ongoing clinical momentum in blood-based diagnostics for hard-to-diagnose infections, where speed and specificity can directly affect outcomes.