Today, Zepto Life Technology announced the launch of the FungiFlex Mold Panel, a plasma-based molecular diagnostic test now available through its CLIA-certified reference laboratory. The new offering expands access to faster, noninvasive testing for patients at risk of invasive fungal infections (IFIs), a group of diseases that remain difficult to diagnose with current standard methods.
“Delayed diagnosis remains one of the biggest challenges in managing invasive fungal infections,” Zepto Life Technology CEO Hannah Zhang said in a statement. “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 detects fungal cell-free DNA (cfDNA)—small fragments of DNA circulating in the bloodstream—from a single plasma sample. The test is designed to identify 21 clinically important mold species, including major pathogens such as Aspergillus and Mucorales, which are responsible for some of the most severe and life-threatening fungal infections. Using Zepto’s fully automated, sample-to-result system, results are typically available within approximately 24 hours of sample receipt.
What You Need to Know
The FungiFlex Mold Panel uses a single plasma sample to detect fungal cell-free DNA, delivering results in about 24 hours without the need for invasive procedures like biopsies or bronchoalveolar lavage.
The test identifies 21 clinically important mold species, including high-risk pathogens such as Aspergillus and Mucorales, which are often associated with severe invasive fungal infections.
While currently offered through Zepto’s CLIA-certified reference laboratory, the launch marks the first clinical use of the company’s deployable liquid biopsy platform, paving the way for future point-of-care and decentralized diagnostics.
While the panel is initially being offered as a reference laboratory test, it represents the first clinical deployment of Zepto’s targeted, rapid, and deployable liquid biopsy platform for infectious disease diagnostics. The launch marks a key commercial milestone for the company and serves as an early step toward broader, decentralized clinical use of its technology in the future.
Invasive mold infections are among the most challenging fungal diseases to diagnose. Filamentous fungi grow slowly in culture, often requiring days to weeks before results are available. In many cases, diagnosis depends on invasive and costly procedures such as tissue biopsy or bronchoalveolar lavage, which may still fail to yield definitive results. These delays can have serious consequences, particularly for immunocompromised patients, for whom invasive fungal infections are associated with high mortality rates.
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A targeted, blood-based molecular approach offers a promising alternative. By detecting fungal DNA directly from plasma, clinicians may gain earlier insight into the presence of invasive mold infections without relying on invasive sampling procedures. Earlier detection can support more timely treatment decisions and potentially improve patient outcomes.
The FungiFlex Mold Panel is intended for patients who show symptoms of invasive fungal disease or who have medical conditions that place them at higher risk. This includes individuals undergoing organ or stem cell transplantation, as well as patients receiving immunosuppressive therapies for cancer, autoimmune disorders, or other conditions. All samples are processed at Zepto Life Technology’s CLIA-certified laboratory in St. Paul, Minnesota, ensuring compliance with federal quality and regulatory standards.
Looking ahead, Zepto aims to expand the clinical reach of its liquid biopsy platform beyond invasive fungal infections. The company’s technology is designed to deliver clinically actionable results from a simple blood draw and to scale across additional infectious disease indications, potentially transforming how complex infections are diagnosed and managed.
Zepto Life Technology is a molecular diagnostics company focused on developing rapid, deployable liquid biopsy platforms for infectious disease. Beginning with invasive fungal infections, the company aims to provide clinicians with faster, less invasive diagnostic tools that can improve patient care and support better clinical decision-making.
Reference
1.Zepto Life Technology Launches Plasma-Based FungiFlex® Mold Panel as CLIA Reference Laboratory Test. Zepto press release. January 21, 2026. Accessed January 21, 2026.
https://www.prnewswire.com/news-releases/zepto-life-technology-launches-plasma-based-fungiflex-mold-panel-as-clia-reference-laboratory-test-302666682.html?tc=eml_cleartime
