Zepto Life Technology Receives FDA Breakthrough Device Designation for Targeted Liquid Biopsy Test for Invasive Mold Infections

ST. PAUL, Minn., June 3, 2026 /PRNewswire/ -- Zepto Life Technology announced today that the U.S. Food and Drug Administration (FDA) 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 (LDT).

Learn more or submit a testing request at:
https://zeptolife.com/diagnostic-testing/

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 challenging.

The FungiFlex^® Mold Panel is a liquid biopsy test that detects fungal cell-free DNA (cfDNA) 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 important limitations of current diagnostic approaches and provide 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. "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 recognizes the potential of the FungiFlex^® Mold Panel to address a significant unmet need in the diagnosis of invasive mold infections.

About Zepto Life Technology

Zepto Life Technology is a molecular diagnostics company developing targeted liquid biopsy diagnostics for infectious diseases using proprietary Giant Magnetoresistance (GMR) biosensor technology. The company's Zepto MDx platform is designed to enable highly sensitive detection and identification of pathogens directly from blood, beginning with invasive fungal infections.

For information regarding clinical testing services, collaborations, or partnership opportunities, visit https://zeptolife.com/diagnostic-testing/

Media Contact: [email protected]

SOURCE Zepto Life Technology