Products

MBio Diagnostics is dedicated to improving patient outcomes by enabling comprehensive diagnostics at the point-of-care (POC) from a single patient sample. By exploiting our innovative and proprietary optical technology, we deliver testing systems for the rapid diagnosis and management of multiple diseases simultaneously.

For physicians, increased diagnostic utility is critical in making faster and better clinical decisions and in improving healthcare delivery. The ability to derive an actionable set of POC diagnostic results within the timeframe of a patient visit provides for faster initiation or modification of therapy. For patients, this translates into more convenient and better healthcare.

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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 CD4 System

Approximately 33 million people are infected with HIV worldwide. Since the destruction of CD4 T helper cells is the central immunological feature of HIV infection, CD4 count is critical to monitoring disease progression. The majority of infected individuals do not have access to rapid, affordable CD4 counts, making point-of-care CD4 testing a recognized global health priority. The MBio CD4 system is designed to deliver absolute CD4 T helper cell counts at the point-of care in minutes.

Since April 2011, a prototype has been operating at the Antiviral Research Center (AVRC) in San Diego, CA, where system performance for both venipuncture and finger stick blood is under investigation. Results from the AVRC♦ presented at the Conference on Retroviruses and Opportunistic (CROI) 2012 demonstrate that the Mbio CD4 System has minimal bias relative to gold standard flow cytometry.

♦ Point-of-Care CD4+ Cell Counting Demonstration in San Diego, CA. Lochhead MJ, Givens M, Logan C, Ives JT, Delaney M, Myatt C, Schooley RT, Benson CA. MBio Diagnostics, Inc., Boulder, CO, and 2University of California, San Diego, CA USA.

MBio Array System

The MBio Array 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. Initial development has focused on infectious diseases applications. A combined HIV/Syphilis/Hepatitis C Virus serology system evaluation — “Rapid Multiplexed Immunoassay for Simultaneous Serodiagnosis of HIV-1 and Coinfections”—was published in the Journal of Clinical Microbiology (2011, 49(10), p. 3584-3590). Pre-marketing, research use only prototypes are operating at clinical collaborator sites in Mozambique, Kenya, and Brazil.

These products were initially developed for the rapid diagnosis of complex infectious diseases such as HIV and hepatitis. Through our collaborations with prominent clinical partners, we plan to apply our technology to other diseases of high global impact where patients and healthcare workers can benefit from more comprehensive POC diagnosis.