MBio Diagnostics® is leading a new era in rapid, on-the-spot clinical diagnostics and sample testing. MBio’s portable diagnostics systems consist of simple, robust readers and disposable test cartridges that deliver multiple results from every sample. Built around the company’s innovative, proprietary LightDeck® technology, MBio’s unique fluorescence-based approach can be configured for multiplexed immunoassays, nucleic acid tests or whole cell enumeration. With a broad patent portfolio backed by over 8 years of development expertise and achieved technical milestones, MBio’s platform has been validated through multiple partnerships with industry, academia and government organizations.
MBio’s proven technology delivers an unprecedented combination of benefits
Multiplexing: Cartridges can be configured to run dozens of parallel immunoassays or nucleic acid detection assays from a single sample
Speed: Many immunoassays can be configured to run in minutes in a simple “load-and-go” workflow
Ease-of-Use: The system has been engineered from the ground up to simultaneously minimize user interactions and device complexing; assay workflow is often simply “add sample”
Sensitivity: The technology can deliver the sensitivity of multi-step laboratory protocols (e.g., ELISA) but in a rapid, simple workflow with minimal user interactions
Quantitation: Device output is a quantitative digital intensity signal
Complex Samples: Demonstrated applications include undiluted whole blood, food matrices and environmental samples
Built-In Quality Controls: Every MBio cartridge incorporates multiple parallel controls that assure quality of every test result
Low-Cost: Manufacturable design of the disposable cartridges enables competition in all markets
At the core of all MBio systems is our patented LightDeck® technology, a powerful fluorescence assay illumination and imaging approach. LightDeck® is a unique implementation of planar waveguide technology. While waveguides have been proven by the scientific community for years to be an excellent approach for uniquely sensitive assays, they have not seen widespread uptake in commercial products due to issues of reproducibility and cost. MBio’s scientist and engineers have key, patent-protected advances that solve reproducibility and cost challenges.
For the first time, planar waveguides have been incorporated into low-cost, disposable, injection molded plastic cartridges that deliver highly reproducible cartridge-to-cartridge assay results using a simple, robust fluorescence reader.
The strength of the platform has been proven in multiple implementations all around the world. Recent human clinical research examples include serology assays in the context of tuberculosis disease in Peru and Vietnam, management of HIV patients in Mozambique and malaria diagnosis in Kenya. The publications and technical briefs listed here provide a few examples of the technology in use.