MBio Diagnostics, Inc. and Foundation for Innovative New Diagnostics (FIND) Complete Phase I of TB Serology Program
Published: Apr 24, 2013
BOULDER, CO--(Marketwired - April 22, 2013) - MBio Diagnostics, Inc. announced that it has been collaborating with the Foundation for Innovative New Diagnostics (FIND) on a tuberculosis (TB) serology feasibility project. The project seeks to determine if a set of M. tuberculosis (Mtb) antigens could be useful for serodiagnosis of active TB disease in a point-of-care (POC) assay format. FIND is using MBio's unique multiplexed immunoassay platform to deliver antibody reactivity results for a panel of 57 Mtb proteins using a single 10-microliter whole blood sample from individuals with suspected TB infection. Phase I of the clinical evaluation, conducted in Vietnam and Peru, concluded in February 2013. Phase II, which represents a larger clinical study, began in March 2013.
Based on samples from 200 TB suspects, Phase I validated functionality of the MBio System in advance of the larger-scale study. Installation of the MBio System at each clinical site required less than one hour. For each enrollee, the team evaluated dilutions of fresh whole blood, fresh serum, and frozen serum samples using the MBio System. The research team processed a total of nearly 700 cartridges. Greater than 99% of the cartridges used for clinical samples generated complete serology profile data sets that were uploaded successfully to the FIND database in Geneva. No system failures were reported. Frozen sera were also sent to a reference laboratory for testing via the Luminex® platform. Concordance with the Luminex reference assay was determined to be > 75%, which was within the predetermined acceptance criteria. Based on these results, all Phase I analytical endpoints were met. As a result, the decision was made to move the project into Phase II, which will generate data for a larger sample cohort.
Tuberculosis is the second-leading infectious disease killer of adults in the world, exceeded only by HIV/AIDS. Serological tests for many infectious diseases, including HIV, are now widespread. To date, however, serological tests for TB based on single antigen-antibody interactions have not provided sufficient sensitivity or specificity. Despite the enormity of the TB epidemic, a simple yet inexpensive diagnostic remains a critical unmet need. Blood-based diagnostics that utilize low-volume samples from finger sticks, for example, would be attractive in certain environments.
The MBio multiplexed immunoassay platform enables simultaneous, semi-quantitative measurement of a large panel of antibody-antigen interactions in an easy-to-use disposable assay cartridge. For this discovery project, the MBio cartridge incorporates an 88-spot array, including approximately 60 protein antigens and 28 control spots.
About MBio Diagnostics Inc.:
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 System is initially being commercialized to manage the treatment of HIV patients from a single drop of blood. The MBio elegant detection system is being developed for a broad menu of applications including multiplex assays and cellular analysis.
The Foundation for Innovative Diagnostics (FIND) is a nonprofit foundation, headquartered in Geneva, Switzerland. FIND is dedicated to driving the development and early implementation of innovative diagnostic tests that have high impact on patient care and disease control in low-resource settings.
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