St. Paul, Minnesota, August,11, 2026
Zepto Life Technology has been awarded 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 supports the company’s FungiFlex® program through engineering and manufacturing activities and, subject to achievement of development milestones, a planned multicenter clinical study intended to support a future U.S. Food and Drug Administration (FDA) submission. The development represents a significant step toward deploying liquid biopsy technology directly within hospital and clinical microbiology laboratories for infectious disease diagnosis.
NIAID Contract Supports FungiFlex Development
The NIAID contract includes a funded base period and additional option periods, with an initial award of $1.9 million and the potential for total funding of up to $8.9 million if all contract options are exercised. The funding is intended to support the continued development of Zepto’s integrated molecular diagnostic system, including engineering, manufacturing and clinical validation activities. If planned project milestones are achieved, the program is expected to advance into a multicenter clinical study designed to generate evidence for a future FDA regulatory submission.
The award builds on regulatory and commercial progress already achieved by Zepto. The company’s FungiFlex Mold Panel has received FDA Breakthrough Device Designation and is currently available for physician ordering through Zepto’s CLIA-certified reference laboratory. The new NIAID-supported development program is focused on taking the technology beyond centralized testing and toward a deployable platform capable of bringing liquid biopsy-based infectious disease testing closer to patients and healthcare providers.
Liquid Biopsy Targets Invasive Fungal Infections
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Invasive fungal infections can pose serious risks to vulnerable populations, including people with cancer, transplant recipients, older adults and individuals with weakened immune systems. Zepto states that delays in diagnosis contribute to significant morbidity and mortality associated with these infections. Conventional diagnostic approaches may require invasive collection of tissue or fluid from affected sites, while blood-based testing can be slow, inconclusive or unable to identify the specific pathogen. Zepto’s Zepto MDx™ platform is designed to address these challenges by detecting pathogen-derived cell-free DNA directly from plasma. The approach uses a standard blood draw to identify targeted infectious pathogens without waiting for traditional culture results or relying on invasive specimen collection.
By bringing molecular liquid biopsy capabilities into hospital and clinical microbiology laboratories, the company aims to reduce the time between clinical suspicion of infection and obtaining actionable diagnostic information. FungiFlex® is the first family of tests developed for the Zepto MDx platform, beginning with invasive fungal infections. The technology is intended to provide targeted identification of fungal pathogens through minimally invasive plasma testing, potentially supporting faster diagnostic decision-making for patients at high risk of serious infection.
Zepto Advances Toward Clinical Validation
According to Hannah Zhang, Chief Executive Officer of Zepto Life Technology, the NIAID award will help the company advance its technology from testing through its CLIA-certified reference laboratory toward a deployable liquid biopsy platform for infectious disease. The company aims to make this capability available directly within hospital microbiology laboratories, bringing diagnostic information closer to the point at which clinicians first suspect infection. The planned development program represents an important milestone for Zepto as it works to transition its liquid biopsy technology toward broader clinical deployment.
The combination of federal funding, FDA Breakthrough Device Designation, engineering and manufacturing development, and planned multicenter clinical validation provides a pathway toward a potential future regulatory submission. The NIAID contract highlights growing interest in rapid molecular diagnostics and innovative infectious disease testing technologies. If development milestones are successfully achieved, Zepto’s platform could expand the role of plasma-based liquid biopsy beyond oncology and into infectious disease diagnostics, beginning with invasive fungal infections. However, the future clinical and regulatory performance of the technology remains subject to ongoing development and validation.
Source: Zepto Life Technology press release
