The liquid biopsy panel identifies fungal DNA in plasma to help clinicians diagnose life-threatening infections in immunocompromised patients.
RT’s Three Key Takeaways:
- FDA Designation: The Food and Drug Administration (FDA) granted Breakthrough Device Designation to the FungiFlex Mold Panel for the diagnosis of invasive mold infections.
- Direct Detection: The liquid biopsy test identifies fungal cell-free DNA directly from plasma to provide organism-level identification for pathogens including Aspergillus, Mucorales, Fusarium, and Scedosporium/Lomentospora.
- Diagnostic Availability: The panel is currently available for physician ordering as a laboratory developed test through Zepto Life Technology’s CLIA-certified laboratory.
Zepto Life Technology announced that the USFDA granted Breakthrough Device Designation to the FungiFlex Mold Panel, a liquid biopsy test designed to aid in the diagnosis of invasive mold infections.
The test detects and identifies fungal cell-free DNA (cfDNA) directly from plasma samples. According to a news release from the company, the panel identifies clinically relevant mold pathogens, including Aspergillus, Mucorales, Fusarium, and Scedosporium/Lomentospora.
Invasive mold infections are among the most difficult infectious diseases to diagnose and are associated with significant morbidity and mortality in immunocompromised patients, the company stated. Standard diagnosis typically requires the integration of imaging, microbiology, histopathology, and serologic testing, yet identifying specific organisms remains a challenge for healthcare providers.
“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.”
The FDA Breakthrough Devices Program is designed to 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 an unmet need in the diagnosis of invasive mold infections by providing diagnostic clarity at the time an infection is suspected.
The FungiFlex Mold Panel is currently available for physician ordering through the company’s CLIA-certified laboratory as a laboratory developed test. The company is developing the test using proprietary Giant Magnetoresistance biosensor technology, which is designed to enable sensitive detection of pathogens directly from blood samples.
