Zepto Life Technology has announced the launch of the FungiFlex® Mold Panel, a plasma-based molecular diagnostic test now available through its CLIA-certified reference laboratory, expanding access to faster, noninvasive testing for patients at risk of invasive fungal infections (IFIs).
The FungiFlex Mold Panel detects cell-free DNA (cfDNA), small fragments of fungal DNA circulating in the bloodstream, from a single plasma sample and is designed to identify 21 clinically important mold species, including Aspergillus and Mucorales pathogens. The test runs on Zepto’s fully automated, sample-to-result system and delivers results in approximately 24 hours from sample receipt.
While initially offered as a reference laboratory test, the FungiFlex Mold Panel represents the first clinical deployment of Zepto’s targeted, rapid, and deployable liquid biopsy platform for infectious disease diagnostics, marking an important commercial milestone and an initial step toward broader decentralized clinical use.
Invasive mold infections, caused by filamentous fungi, are among the most difficult fungal diseases to diagnose. These organisms are slow-growing and often require days to weeks to culture, while diagnosis today frequently relies on invasive and costly procedures, such as tissue biopsy or bronchoalveolar lavage, that may be nondiagnostic. As a result, diagnosis is often delayed, contributing to high mortality rates, particularly in immunocompromised patients. A targeted, blood-based molecular approach enables earlier clinical insight without the need for invasive sampling.
“Delayed diagnosis remains one of the biggest challenges in managing invasive fungal infections,” said Hannah Zhang, CEO of Zepto Life Technology. “By launching FungiFlex as a reference laboratory test, we are making this targeted approach available today, while advancing a platform designed for rapid deployment closer to patient care.”
The FungiFlex Mold Panel is intended for patients with symptoms of, or medical conditions predisposing them to, invasive fungal disease, including individuals undergoing transplantation or receiving immunosuppressive therapies. Samples are processed at Zepto Life Technology’s CLIA-certified laboratory in St. Paul, Minnesota.
About Zepto Life Technology
Founded in 2014, Zepto Life Technology is a privately held company based in St. Paul, Minnesota. We are at the forefront of developing groundbreaking products that can detect invasive fungal infections using cell-free DNA found in blood. Our cutting-edge detection technology, Giant Magneto Resistance (GMR), is renowned for its high sensitivity and specificity. This Nobel Prize-winning technology from 2007 enables us to detect multiple infections accurately without compromising specificity.
In collaboration with Mayo Clinic, Zepto Life Technology is committed to advancing healthcare by providing precise and reliable diagnostic solutions.