The panel detects fungal DNA in plasma to help identify specific pathogens in immunocompromised patients.
Zepto Life Technology announced that the Food and Drug Administration (FDA) granted Breakthrough Device Designation to its FungiFlex Mold Panel. The liquid biopsy test is designed to aid in the diagnosis of invasive mold infections by detecting and identifying fungal cell-free DNA directly from plasma.
The panel is currently available for physician ordering through the company’s CLIA-certified laboratory as a Laboratory Developed Test. By providing organism-level identification directly from plasma, the test is intended to address limitations of current diagnostic approaches and provide diagnostic clarity when an invasive mold infection is suspected.
Targeting Pathogen Identification
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 the integration of imaging, microbiology, histopathology, and serologic testing, yet identifying specific organisms remains difficult.
The FungiFlex Mold Panel identifies clinically relevant mold pathogens, including Aspergillus, Mucorales, Fusarium, and Scedosporium/Lomentospora.
“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,” says Hannah Zhang, CEO of Zepto Life Technology, in a release. “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.”
FDA Breakthrough Program Goals
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 panel to address a significant unmet need in the diagnosis of invasive mold infections.
Zepto Life Technology is developing the test using proprietary giant magnetoresistance biosensor technology. The company’s platform is designed to enable sensitive detection and identification of pathogens directly from blood, beginning with invasive fungal infections.
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