Zepto Life Technology’s invasive mould detection test has secured a breakthrough device designation from the US Food and Drug Administration (FDA).
The Minnesota-based company’s FungiFlex Mold Panel is a liquid biopsy test designed to aid in the diagnosis of invasive mould infections through the detection and identification of fungal cell-free DNA directly from plasma.
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Developed using Zepto’s proprietary Giant Magnetoresistance (GMR) biosensor technology, FungiFlex is designed to detect fungal cell-free DNA (cfDNA) circulating in plasma. The assay is capable of identifying 14 clinically relevant mould pathogens, including Aspergillus, Mucorales, Fusarium, and Scedosporium/Lomentospora.
According to Zepto, existing diagnostic approaches often require integration of imaging, microbiology, histopathology, and serologic testing, with organism-level identification continuing to be a challenge with this combination of diagnostic testing.
For this reason, by providing organism-level identification directly from plasma, Zepto’s test addresses the limitations of current diagnostic approaches and provides diagnostic clarity at the time invasive mould infection is suspected, the company stated.
Elaborating further, Hannah Zhang, CEO of Zepto Life Technology, said: “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.
“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 FungiFlex Mold Panel is now available through Zepto Life Technology’s CLIA-certified laboratory as a laboratory-developed test (LDT).
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.
