MBio Diagnostics is leading a new era in rapid, on-the-spot clinical diagnostics and sample testing. Our portable MBio multiplex analyzer and disposable cartridge enable low-cost, rapid answers in 1 to 20 minutes. Our proprietary optical technology allows multiple clinical and analytical tests to be run simultaneously.

Our comprehensive platform for detection, measurement and bioanalysis delivers results on a single disposable cartridge and enables an on-the-spot panel of results. No need to send out a sample and no need to wait for an answer.

Products in Development

Built on our unique, optical technology, each product in development is a diagnostic system combining an easy-to-use, software-driven portable reader with single-use disposable cartridges for a variety of assay formats and sample types.

MBio’s products are for research use only and are not approved for human diagnostics use.

MBio Array System

The MBio Array System is a multiplexed fluorescence immunoassay system that provides the simultaneous and accurate measurement of multiple analytes from a single sample. The system is readily configured to run multiple immunoassays in parallel on a simple-workflow, disposable cartridge.

Our game-changing system enables rapid, on-the-spot analysis allowing for faster decision making. A study demonstrating the speed, utility and multiplexing capabilities of the company’s MBio Array System in detecting antibiotic residue in raw milk was recently published online in Analytical and Bioanalytical Chemistry, titled “Development of a rapid multiplexed assay for the direct screening of antimicrobial residues in raw milk.”

The MBio Array System has been implemented in high value research studies at 12 sites across the globe. Through this process, MBio has engaged international partners, global diagnostic companies and government agencies to test and validate the system.

The MBio System was initially developed for the rapid diagnosis of complex infectious diseases such as HIV and hepatitis. Through our various collaborations with prominent partners, we are addressing a range of clinical diagnostics and sample testing needs from medical to environmental and agricultural.

CASE STUDY:  Human Immune Response During Tuberculosis Infection

Vietnam_TrainingTuberculosis (TB) is a resurgent infectious disease and a critical global health challenge.  According to the World Health Organization, in 2013, 1.5 million people died from TB and 9 million people were ill with the disease.  Yet diagnosis of TB disease remains challenging, typically requiring a sub-optimal combination of microscopy, culture, X-rays, and relatively expensive molecular testing.  A global health priority has been to develop simpler, faster TB diagnostics.

The Foundation for Innovative New Diagnostics (FIND) based in Geneva, Switzerland has been at the forefront of TB diagnostics development and is leading a major effort to identify biomarkers indicative of TB disease.  In one such program, FIND sought a point-of-care testing platform that could measure up to 60 antigen-antibody interactions simultaneously in small clinical samples including whole blood or serum.  The MBio System was FIND’s platform of choice for the study due to its portability, ease-of-use and quality of results.  Working together, the FIND and MBio team developed a disposable cartridge that delivered 88 simultaneous antigen-antibody interactions, including a panel of 57 recombinant M. tuberculosis proteins used for serology profiling.  The system was then run in clinical trials at sites in Lima, Peru and Ho Chi Minh City, Vietnam over an 18 month period.

The MBio System met all platform operational objectives.  MBio produced over 2400 cartridges for the study.  Training at each site was completed in one day (the photo here shows training at the Vietnam site).  There were no instrument failures recorded during this study and clinical results showed concordance with Luminex® assays run at a reference laboratory [Greef, et al. Conference on Retroviruses and Opportunistic Infections (CROI), 2014].

This study demonstrated an unprecedented combination of multiplexing, quantitation, and portability and established the MBio System as a unique and powerful tool for clinical research and diagnostics development in field settings.

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CASE STUDY:  Unprecedented Detection of Marine and Freshwater Algal Toxins

Harmful algal blooms in both marine and freshwater environments have significant adverse impacts on fisheries and aquaculture and present real human health risks by introducing toxins into the food supply.  Many people saw the impact of harmful algal blooms during the summer of 2014, when an event in Lake Erie led to dangerous levels of a toxin called microcystin and closed the water supply for 500,000 people in Toledo, Ohio.

The Institute for Global Food Security (IGFS) at Queen’s University, Belfast, Northern Ireland is a leader in toxin detection strategies.  IGFS scientists have been working with the MBio system for several years, developing innovative multiplexed immunoassays that deliver extraordinary levels of sensitivity for toxin detection.  For example, a recent publication in the journal Environmental Science and Technology (McNamee et al, Environ. Sci. Technol. 2014, 48, 13340−13349) states that the MBio system delivers rapid, easy to use, and highly sensitive screening” and that the research “demonstrates an early warning screening assay to support national monitoring agencies by providing a faster and more accurate means of identifying and quantifying harmful toxins in water samples.”   The IGFS work and related research at partner institution Dublin City University continue to appear in high impact scientific journals and the tests are now entering a commercialization phase