Plasma Cell-Free DNA Test Enables Earlier Diagnosis of Invasive Fungal Infections

Invasive fungal infections disproportionately affect immunocompromised patients, while diagnostic delays can contribute to substantial morbidity and mortality. Existing methods often depend on invasive sampling or prolonged culture, and blood-based testing may be slow or inconclusive. A new deployable liquid biopsy system aims to address these limitations by enabling earlier, pathogen-specific detection directly from plasma.

Zepto Life Technology has received a contract valued at up to $8.9 million from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to advance its plasma cell-free DNA (cfDNA) liquid biopsy platform for invasive fungal infections. The award funds the FungiFlex program from engineering and manufacturing through planned clinical validation and a future submission to the U.S. Food and Drug Administration (FDA). The contract establishes a funded base period and option periods tied to development milestones.

Zepto developed the Zepto MDx platform to detect pathogen-derived cfDNA directly from plasma, enabling targeted identification of infectious pathogens from a standard blood draw without waiting for culture or relying on invasive specimen collection. Designed for deployment in hospital and clinical microbiology laboratories, the system brings liquid biopsy testing in-house and closer to the patient to shorten time from clinical suspicion to an actionable diagnosis. FungiFlex is the first test family built for Zepto MDx, beginning with invasive fungal infections.

Within this menu, the FungiFlex Mold Panel has received FDA Breakthrough Device Designation and is available for physician ordering through Zepto’s CLIA-certified reference laboratory. The NIAID contract supports continued engineering and manufacturing of an integrated molecular diagnostic system and, contingent on milestone achievement, a planned multi-center clinical study designed to support a future FDA submission. NIAID has made an initial award of $1.9 million, with total funding of up to $8.9 million possible if all contract options are exercised.

“Today, FungiFlex is available through our CLIA reference laboratory, but we’ve always been building toward something bigger. This award helps us advance Zepto’s technology as a deployable liquid biopsy platform for infectious disease and bring that capability directly into hospital microbiology laboratories. That means getting clinicians actionable answers closer to the moment they first suspect an infection,” said Hannah Zhang, Chief Executive Officer of Zepto Life Technology.

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