The FungiFlex Mold Panel provides a noninvasive alternative to biopsies for identifying invasive fungal infections in immunocompromised patients.
RT’s Three Key Takeaways:
- Noninvasive Diagnostic Tool: The FungiFlex Mold Panel identifies 14 clinically important mold species, including Aspergillus and Mucorales, using a single plasma sample to detect circulating cell-free DNA.
- Rapid Results: The test delivers findings in less than 24 hours from sample receipt, offering a significant time advantage over traditional culture methods that can take weeks.
- Clinical Alternative: This blood-based molecular approach provides an alternative to invasive and costly procedures like biopsies or bronchoalveolar lavage for immunocompromised patients.
Zepto Life Technology has launched the FungiFlex Mold Panel, a plasma-based molecular diagnostic test available through its Clinical Laboratory Improvement Amendments (CLIA) certified reference laboratory, according to the company. The test provides a noninvasive method for detecting invasive fungal infections (IFIs) in high-risk patients.
The diagnostic tool identifies cell-free DNA (cfDNA), which are small fragments of fungal DNA circulating in the bloodstream. By utilizing a single plasma sample, the panel can detect 14 different mold species, including Aspergillus and Mucorales pathogens. While currently offered as a reference laboratory test, the panel is the initial offering of a rapid liquid biopsy platform intended for future decentralized clinical use, according to the news release.
Invasive mold infections most commonly affect immunocompromised patients and are historically difficult to diagnose because the organisms grow slowly. Current diagnostic standards often require days or weeks for cultures or involve invasive procedures such as biopsies or bronchoalveolar lavage. These delays often contribute to high mortality rates in vulnerable populations.
“Delayed diagnosis remains one of the biggest challenges in managing invasive fungal infections,” said Hannah Zhang, ceo of Zepto Life, in a news release. “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 panel is intended for patients who are undergoing transplantation, receiving immunosuppressive therapies, or presenting with medical conditions predisposing them to invasive fungal disease. All samples are processed at the Zepto Life Technology CLIA-certified laboratory in St Paul, Minnesota.
