Zepto Life Technology Receives FDA Breakthrough Device Designation for FungiFlex Mold Panel Liquid Biopsy Test
核心洞察
The FDA has granted Breakthrough Device Designation to Zepto Life Technology (搜索)'s FungiFlex Mold Panel (搜索), a liquid biopsy test for invasive mold infections (搜索).
The test detects fungal cell-free DNA directly from plasma, identifying pathogens including Aspergillus (搜索), Mucorales (搜索), Fusarium (搜索), and Scedosporium/Lomentospora (搜索).
Invasive mold infections (搜索) are associated with significant morbidity and mortality in immunocompromised patients, and current diagnostic approaches often fail to provide organism-level identification.
The U.S. Food and Drug Administration has granted Breakthrough Device Designation to the FungiFlex Mold Panel (搜索), a targeted liquid biopsy test developed by Zepto Life Technology (搜索) for the diagnosis of invasive mold infections (搜索). The announcement was made by the St. Paul, Minnesota-based molecular diagnostics company on June 3, 2026.
The FungiFlex Mold Panel (搜索) is designed to detect and identify fungal cell-free DNA (cfDNA) circulating in plasma, providing organism-level identification of clinically relevant mold pathogens directly from a blood sample. The test is currently available for physician ordering through Zepto Life Technology (搜索)'s CLIA-certified laboratory as a Laboratory Developed Test (LDT).
Addressing a Critical Diagnostic Gap
Invasive mold infections (搜索) represent some of the most challenging infectious diseases to diagnose and are associated with significant morbidity and mortality, particularly in immunocompromised patients. Current diagnostic workflows often require the integration of multiple modalities — including imaging, microbiology, histopathology, and serologic testing — yet achieving organism-level identification remains a persistent challenge.
The FungiFlex Mold Panel (搜索) targets this unmet need by detecting fungal cfDNA from pathogens including Aspergillus (搜索), Mucorales (搜索), Fusarium (搜索), and Scedosporium/Lomentospora (搜索). By providing organism-level identification directly from plasma, the test is designed to address important limitations of existing diagnostic approaches and deliver diagnostic clarity at the time invasive mold infection is suspected.
"One of the most frustrating realities in invasive fungal infections is that clinicians are often forced to make critical treatment decisions without knowing exactly which organism is causing disease," said Hannah Zhang, Chief Executive Officer of Zepto Life Technology (搜索). "Our goal has always been to provide actionable organism-level information from a simple plasma sample. We believe targeted liquid biopsy testing has the potential to fundamentally change how these infections are diagnosed."
Regulatory Pathway and Technology Platform
The FDA Breakthrough Devices Program is intended to accelerate the development and review of technologies that may provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases. The Breakthrough Device Designation recognizes the potential of the FungiFlex Mold Panel (搜索) to address a significant unmet need in the diagnosis of invasive mold infections (搜索).
Zepto Life Technology (搜索)'s diagnostic platform is built on proprietary Giant Magnetoresistance (GMR) biosensor technology. The company's Zepto MDx platform is engineered to enable highly sensitive detection and identification of pathogens directly from blood, with an initial focus on invasive fungal infections. The company is also developing targeted liquid biopsy diagnostics for other infectious diseases.