Zepto Life Technology announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the FungiFlex Mould Panel, a liquid biopsy test designed to aid in the diagnosis of invasive mould infections through the detection and identification of fungal cell-free DNA directly from plasma.
The FungiFlex Mould Panel is currently available for physician ordering through Zepto Life Technology's CLIA-certified laboratory as a Laboratory Developed Test (LDT).
Invasive mould 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 challenging.
The FungiFlex Mould Panel is a liquid biopsy test that detects fungal cell-free DNA (cfDNA) circulating in plasma and identifies clinically relevant mould pathogens, including Aspergillus, Mucorales, Fusarium, and Scedosporium/Lomentospora. By providing organism-level identification directly from plasma, the test is designed to address important limitations of current diagnostic approaches and provide diagnostic clarity at the time invasive mould 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. "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."
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. Breakthrough Device Designation recognises the potential of the FungiFlex Mould Panel to address a significant unmet need in the diagnosis of invasive mould infections.
