Rapid microbial contamination detection from aqueous solutions using fcmbl technology
Broad-spectrum pathogen detection technology using engineered Mannose Binding Lectin (FcMBL) to rapidly identify bacteria, fungi, viruses, and parasites in aqueous solutions. Licensed from Harvard's Wyss Institute, the platform eliminates the need for pathogen-specific assays, enabling sensitive detection at concentrations as low as 1 ng/ml through ELISA and lateral flow formats.
Overview
BOA Biomedical's FcMBL technology enables rapid, broad-spectrum detection of microbial contamination in aqueous solutions, including blood and buffer samples. The technology uses an engineered version of a naturally occurring protein, Mannose Binding Lectin (MBL), which binds to pathogens and their debris without targeting healthy human cells. This non-specific binding capability allows a single assay to detect more than 100 different pathogens across bacteria (gram-negative and gram-positive), fungi, parasites, and viruses, eliminating the need for pathogen-specific detection methods.
The platform addresses critical gaps in current diagnostic approaches, particularly for conditions like sepsis, where conventional culture-based methods can take days to identify pathogens. By detecting pathogen-associated molecular patterns (PAMPs) rather than requiring live organisms, the technology offers faster turnaround and improved sensitivity. The approach has demonstrated the ability to distinguish infection from trauma-related inflammation with higher specificity than the current standard of care.
Technical specifications
Key features:
- Engineered FcMBL protein binds to over 100 pathogens including gram-negative and gram-positive bacteria, fungi, parasites, and viruses
- Broad-spectrum binding surface successfully captured 85% of 190 isolates tested and 87% of 112 clinical isolates, spanning bacteria, fungi, viral antigens, and parasites
- Detection sensitivity for PAMPs as low as 1 ng/ml
- Available in ELISA and lateral flow assay (LFA) formats for flexible deployment
- LFA prototype enables point-of-testing use with results in minutes rather than days
- Compatible with multiple sample types including blood, buffer, and other aqueous solutions
- Pre-capture of pathogens improves detection sensitivity compared to live pathogen detection alone
Technology readiness level
The technology has progressed through initial validation with both ELISA and lateral flow assay prototypes. The ELISA format has been used in suspected sepsis patient studies, demonstrating the ability to distinguish infection from trauma-related inflammation with higher specificity than current standard-of-care methods. The LFA prototype has shown functionality for measuring fungal infection in the low ng/ml range and for detecting both live and sonicated bacteria.
Future development will focus on optimizing the current LFA prototype to achieve the high sensitivity required for bacterial contamination detection across aqueous solutions of varying composition. Planned limit-of-detection studies will evaluate performance against R. pickettii, B. diminuta, P. aeruginosa, and M. abscessus, along with additional bacteria and fungi species of interest. The technology is licensed from Harvard University's Wyss Institute and is being advanced toward broader commercial and clinical applications.
About BOA Biomedical
BOA Biomedical is a medical technology company focused on rapidly diagnosing and treating severe infectious diseases, including sepsis, antibiotic-resistant infections, and pandemic pathogens. Founded in 2018 as a Miraki Innovation company, it develops platform technologies licensed from Harvard University’s Wyss Institute, including an extracorporeal blood cleansing therapeutic known as GARNET. This system is designed to physically remove a broad spectrum of pathogens—such as bacteria, fungi, viruses, and parasites—and their inflammation-triggering debris directly from a patient’s bloodstream to stabilize health. The company also develops companion diagnostic tools, such as the AGATE, Amethyst, and Rubellite systems, which aim to provide rapid, culture-free identification of pathogens to improve clinical decision-making.
By addressing the root causes of infection rather than just symptoms, BOA Biomedical aims to provide essential countermeasures for hospital-acquired infections, biothreats, and global outbreaks. Its technology seeks to solve the critical issue of slow conventional diagnostic methods, which often take days to identify pathogens. The company has moved its GARNET therapeutic into first-in-human clinical trials to evaluate safety and clinical utility, positioning its platform as a potential solution for patients suffering from life-threatening bloodstream infections. The firm has collaborated with government research agencies, including the U.S. Department of Defense, to advance these medical technologies.
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