Zepto Life Technology announced today that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to the FungiFlex® Mold Panel, a liquid biopsy test designed to aid in the diagnosis of invasive mold infections through detection and identification of fungal cell-free DNA directly from plasma.
The FungiFlex® Mold Panel is currently available for physician ordering through Zepto Life Technology's CLIA-certified laboratory as a laboratory-developed test. The designation announced today applies specifically to the Mold Panel performed on Zepto's integrated MDx instrument system, which remains in development and is not yet FDA-cleared or approved.
Invasive mold infections are among the most challenging infectious diseases to diagnose and are associated with significant morbidity and mortality in immunocompromised patients. Diagnosis often requires integration of imaging, microbiology, histopathology, and serologic testing, yet organism-level identification remains difficult using conventional methods.
The FungiFlex® Mold Panel detects fungal cell-free DNA circulating in plasma and identifies clinically relevant mold pathogens, including Aspergillus, Mucorales, Fusarium, and Scedosporium/Lomentospora. By providing organism-level identification directly from plasma, the test is designed to address key limitations of current diagnostic approaches at the moment invasive mold infection is first 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. Our goal has always been to provide actionable organism-level information from a simple plasma sample."
— Hannah Zhang, Chief Executive Officer of Zepto Life Technology
About the FDA Breakthrough Devices Program
The FDA Breakthrough Devices Program is intended to help accelerate the development of technologies that may provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases. The designation recognizes the potential of the FungiFlex® Mold Panel to address a significant unmet need in the diagnosis of invasive mold infections, and provides for more interactive engagement with FDA during development. It does not indicate that the device has been evaluated, cleared, or approved for sale in the U.S.