MBio Diagnostics presents tuberculosis study results

MBio Diagnostics, Inc.
March 12, 2014, 8:37 p.m.

Boulder, CO, March 11, 2014 – MBio Diagnostics, Inc. presented results last week of a study entitled "Highly Multiplexed Detection of Antibodies in Whole Blood during Tuberculosis Infection" at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, MA. MBio is collaborating with the Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland, on a program aimed at developing a simple, point-of-care blood test for active tuberculosis disease (TB) using MBio's multiplexed immunoassay platform.

Simple TB screening diagnostics are a critical unmet need worldwide. The MBio-FIND clinical study is based on measuring over 80 protein-antibody interactions in a single drop of blood, and is being conducted at sites with endemic tuberculosis in Peru and Vietnam. The CROI presentation focused on the first phase of the study, which evaluated the operational and analytical performance of the MBio system. Based on enrollment of 200 TB suspects, the MBio platform met all Phase 1 endpoints, including high concordance with reference testing (Luminex bead array). Importantly, more than 99% of the 600 MBio cartridges that were tested delivered complete serology profiles, providing the groundwork for a rich, valuable dataset for understanding TB diagnosis. In addition to the data quality, the MBio system also met all operational endpoints linked to ease-of-use, training, quality control, and system performance.

Commenting on the results, Chris Myatt, CEO of MBio Diagnostics, said, "This study demonstrates the truly unique capabilities of the MBio system. Our ability to deliver over 80 simultaneous blood marker results from a single drop of blood in a matter of minutes using a simple, disposable cartridge is unprecedented in the diagnostics field. The fact that we are doing this in a near patient setting, without requiring sophisticated laboratory infrastructure further differentiates the MBio system. Our system has the potential to drive major advances in rapid diagnosis of immunologically complex conditions such as tuberculosis."

About MBio Diagnostics

MBio Diagnostics, Inc. (www.mbiodx.com) is a privately held diagnostics and life sciences company based in Boulder, CO. MBio Diagnostics is increasing access to quality healthcare by delivering innovative and low cost point-of-care (POC) diagnostics. The MBio platform enables highly multiplexed testing from a single drop of blood, and it is being developed for highly differentiated applications requiring multiplex assays and cellular analysis.

About FIND

The Foundation for Innovative New Diagnostics (FIND) works with partners to develop reliable and affordable diagnostic tests for diseases of poverty, saving lives in resource-limited settings. FIND is a Swiss-based non-profit organization financed by donors in the private and public sectors. www.finddiagnostics.org

Source: MBio Diagnostics, Inc.