Blood Test Promises Faster Answers for Deadly Fungal Infections

Invasive mold infections caused by filamentous fungi are among the most challenging fungal diseases to diagnose, as the organisms grow slowly and often take days to weeks to culture. Current diagnostic approaches frequently rely on invasive, costly procedures that may be nondiagnostic, leading to delayed detection and high mortality rates, particularly in immunocompromised patients. Now, a newly launched blood-based molecular approach addresses these challenges by enabling earlier clinical insight without invasive sampling.

Zepto Life Technology (Saint Paul, MN, USA) has launched 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 test runs on Zepto’s fully automated, sample-to-result system and delivers results in approximately 24 hours from sample receipt.

FungiFlex detects cell-free DNA from a single plasma sample and is designed to identify 21 clinically important molds, including Aspergillus and Mucorales species. By using a targeted molecular approach rather than culture, the test aims to deliver earlier, actionable results for suspected invasive fungal infections. The launch represents the first clinical deployment of Zepto’s targeted, rapid, deployable liquid biopsy platform for infectious disease diagnostics, marking a key commercial milestone and an initial step toward broader decentralized clinical use.

The test is intended for patients with symptoms or risk factors for invasive fungal disease, such as those undergoing transplantation or receiving immunosuppressive therapy. Samples are processed at Zepto Life Technology’s CLIA certified laboratory in St. Paul, Minnesota. “Delayed diagnosis remains one of the biggest challenges in managing invasive fungal infections,” said Hannah Zhang, CEO of Zepto Life. “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.”

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