MBio Technology

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

LightDeck® Technology

 

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 scientists 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.

Publications

MBio's work with partners, collaborators and customers has resulted in a growing list of peer-reviewed publications spanning diverse applications:

 

Broger T, et al. “Diagnostic performance of tuberculosis-specific IgG antibody profiles in patients with presumptive TB from two continents,” Clinical Infectious Diseases, 2017.
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Logan C, et al. “Rapid Multiplexed Immunoassay for Detection of Antibodies to Kaposi's Sarcoma-Associated Herpesvirus,” PLoS One, 2016;11(9): e0163616. Epub 2016/09/27. doi: 10.1371/journal.pone.0163616. PubMed PMID: 27669509; PMCID: PMC5036886.
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Givens M, et al. “Near patient CD4 count in a hospitalized HIV patient population,” Cytometry Part B, Clinical Cytometry. 2015. doi: 10.1002/cyto.b.21248. PubMed PMID: PMCID: 25917935.
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Logan C, et al. “Performance evaluation of the MBio Diagnostics point-of-care CD4 counter,” Journal of Immunological Methods, 2013;387(1-2):107-13. Epub 2012/10/16. doi: 10.1016/j.jim.2012.10.002 S0022-1759(12)00300-6 [pii]. PubMed PMID: 23063690; PMCID: 3529779.
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Lochhead MJ, et al. “Rapid multiplexed immunoassay for simultaneous serodiagnosis of HIV-1 and coinfections,” Journal of Clinical Microbiology. 2011; 49(10): 3584-90. Epub 2011/08/26. doi: JCM.00970-11 [pii] 10.1128/JCM.00970-11. PubMed PMID: 21865431; PMCID: 3187301.
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Reverte L, et al. "Tetrodotoxin detection in puffer fish by a sensitive planar waveguide immunosensor," Sensors and Actuators B: Chemical, 2017 doi: 10.1016/j.snb.2017.06.181
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McGrath TF, et al. “Development of a rapid multiplexed assay for the direct screening of antimicrobial residues in raw milk,” Analytical and Bioanalytical Chemistry, 2015. doi: 10.1007/s00216-015-8526-4. PubMed PMID: 25701420.
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McNamee SE, et al. “Development of a planar waveguide microarray for the monitoring and early detection of five harmful algal toxins in water and cultures,” Environmental Science & Technology, 2014;48(22):13340-9. doi: 10.1021/es504172j. PubMed PMID: 25361072.
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Murphy C, et al. “Detection of the cyanobacterial toxin, microcystin-LR, using a novel recombinant antibody-based optical-planar waveguide platform,” Biosensors and Bioelectronics, 2014. doi: 10.1016/j.bios.2014.10.039. PubMed PMID: 25459059.
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Devlin S, et al, “Next generation planar waveguide detection of microcystins in freshwater and cyanobacterial extracts, utilising a novel lysis method for portable sample preparation and analysis,” Analytica Chimica Acta. 2013;769:108-13. Epub 2013/03/19. doi: 10.1016/j.aca.2013.01.033 S0003-2670(13)00181-5 [pii]. PubMed PMID: 23498128.
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Meneely JP, et al. “Development and validation of an ultrasensitive fluorescence planar waveguide biosensor for the detection of paralytic shellfish toxins in marine algae,” Biosensors and Bioelectronics, 2013;41:691-7. Epub 2012/10/30. doi: 10.1016/j.bios.2012.09.043 S0956-5663(12)00649-5 [pii]. PubMed PMID: 23102433.
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