Zepto Life Technology has won a contract worth up to $8.9m from the US National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) to advance the development of its integrated molecular diagnostic system for invasive fungal infections.
The Minnesota-based company’s FungiFlex mould panel is its lead product. It is designed to aid in the diagnosis of invasive mould infections through the detection and identification of fungal cell-free DNA directly from plasma, mitigating the need to wait for culture or rely on invasive specimen collection. Zepto gained breakthrough device designation for the liquid biopsy test from the US Food and Drug Administration (FDA) in June 2026.
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Developed using Zepto’s proprietary giant magnetoresistance (GMR) biosensor technology, FungiFlex, which is currently available through Zepto’s CLIA-certified laboratory as a laboratory-developed test (LDT), is capable of identifying 14 clinically relevant mould pathogens, including Aspergillus, Mucorales, Fusarium, and Scedosporium/Lomentospora.
Under the NIAID contract’s terms, Zepto has been awarded an initial $1.9m, with the potential for the company’s grant funding to swell to $8.9m if contract milestones are met.
The proceeds will support ongoing developmental tenets surrounding Zepto’s integrated molecular diagnostic system, including engineering and manufacturing, and, if all contract stipulations are exercised, a clinical study designed to support a future regulatory filing with the FDA, the company stated.
Zepto’s CEO, Hannah Zhang, said: “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.”
According to the US Centers for Disease Control and Prevention (CDC), misdiagnoses or delayed diagnoses of invasive mould infections are common and can cause high costs, severe illness, and death, with the overall population-based prevalence in the US running at approximately 15 to 18 cases per 100,000 people.
Zepto’s NIAID grant follows the NIH centre’s award of a grant to Gladstone Institutes in June 2026. Worth up to $10m, the California-based biomedical research organisation intends to use the grant to establish the Center for PhAIge Therapy, a research centre that aims to develop new phage-based treatments for antibiotic-resistant bacterial infections.
