SAN DIEGO, Calif., June 3, 2026
Zepto Life Technology has achieved a significant regulatory milestone after receiving U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its FungiFlex® Mold Panel, an innovative liquid biopsy diagnostic designed to detect and identify invasive mold infections directly from a patient’s plasma. The designation recognizes the technology’s potential to address a critical unmet medical need in the diagnosis of life-threatening fungal infections, particularly among immunocompromised patients who face a heightened risk of severe disease and mortality. The breakthrough recognition also underscores growing interest in advanced molecular diagnostics capable of delivering faster, more accurate pathogen identification without the need for invasive tissue sampling. As healthcare providers increasingly seek precision diagnostic solutions that support timely treatment decisions, Zepto’s targeted liquid biopsy platform represents an important advancement in infectious disease detection and management.
FDA Recognizes Potential of Novel Liquid Biopsy Technology
The FDA’s Breakthrough Devices Program is intended to accelerate the development and review of innovative medical technologies that may provide more effective diagnosis or treatment for serious or life-threatening conditions. By granting Breakthrough Device Designation to the FungiFlex® Mold Panel, the agency has acknowledged the test’s potential to significantly improve diagnostic capabilities for invasive mold infections. These infections remain among the most difficult infectious diseases to diagnose due to the complexity of current testing approaches, which often require a combination of imaging studies, microbiological cultures, histopathology, and serologic assessments.
Even with multiple diagnostic methods, achieving organism-level identification remains challenging and can delay the initiation of targeted antifungal therapy. The FungiFlex® Mold Panel aims to overcome these limitations by detecting fungal cell-free DNA (cfDNA) circulating in plasma and identifying specific pathogenic molds directly from a blood sample, providing clinicians with actionable diagnostic information at an earlier stage of disease evaluation.
FungiFlex Targets High-Risk Invasive Mold Infections
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The FungiFlex® Mold Panel is designed to identify several clinically significant fungal pathogens responsible for invasive mold infections, including Aspergillus, Mucorales, Fusarium, and Scedosporium/Lomentospora species. These organisms are associated with severe infections that can rapidly progress in patients with weakened immune systems, including individuals undergoing cancer treatment, organ transplantation, stem cell transplantation, or intensive immunosuppressive therapy. Early and accurate pathogen identification is critical because treatment strategies often vary depending on the specific fungal species involved.
By delivering organism-level identification directly from plasma, the test has the potential to support more precise therapeutic decisions, reduce diagnostic uncertainty, and improve patient outcomes. Currently available through Zepto Life Technology’s CLIA-certified laboratory as a Laboratory Developed Test (LDT), the FungiFlex® Mold Panel represents a new generation of molecular diagnostics focused on enhancing clinical decision-making in infectious diseases where rapid diagnosis can have a profound impact on survival and treatment success.
Advanced Biosensor Platform Expands Molecular Diagnostic Innovation
At the core of the FungiFlex® Mold Panel is Zepto Life Technology’s proprietary Giant Magnetoresistance (GMR) biosensor technology, which powers the company’s broader Zepto MDx platform. The platform is engineered to enable highly sensitive detection and identification of pathogens directly from blood samples, eliminating many of the challenges associated with traditional diagnostic workflows. The FDA designation highlights the growing role of liquid biopsy technologies beyond oncology and into infectious disease diagnostics, where rapid, non-invasive testing is becoming increasingly important. Zepto believes its targeted molecular diagnostic approach could fundamentally transform how invasive fungal infections are identified and managed, particularly in high-risk patient populations.
As development progresses under the FDA’s Breakthrough Device framework, the company is expected to continue advancing clinical validation efforts while exploring additional applications of its biosensor platform. The designation positions Zepto at the forefront of diagnostic innovation and reflects the increasing importance of precision medicine technologies in addressing complex infectious diseases.
Source: Zepto Life Technology press release
