MONDAY, SEPTEMBER 26, 2016

MBio has successful Phase I trial of point-of-care TB assay

MBio Diagnostics, Inc., recently presented the Phase I results of a study that tested the efficacy of its multiplexed immunoassay platform.

MBio is working with the Foundation for Innovative New Diagnostics to develop a simple, point-of-care blood screening assay for active tuberculosis detection that can be used in the field. MBio presented the Phase I results of the study, which was entitled "Highly Multiplexed Detection of Antibodies in Whole Blood during Tuberculosis Infection," at the Conference on Retroviruses and Opportunistic Infections in Boston.

The Phase I study successfully met all endpoints, including successful reference testing, from a test subject group of approximately 200 patients with suspected TB infections from Peru and Vitenam. More than 600 MBio cartridges were tested during the study, 99 percent of which delivered complete serology data. MBio also met all quality control, ease-of-use, training and system performance goals.

"This study demonstrates the truly unique capabilities of the MBio system," MBio CEO Chris Myatt said. "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."