Generex Biotechnology Corporation Announces New Clinical Trial Of Hema Diagnostic Systems’ Rapid 1-2-3 Tuberculosis Point-Of-Care Tests

MIRAMAR, Fla.--(BUSINESS WIRE)--Generex Biotechnology Corporation (OTCPink:GNBT) (www.generex.com) today announced the participation by its subsidiary, Hema Diagnostic Systems LLC (www.hemadiagnosticsystems.com), in a diagnostic clinical trial for tuberculosis in Sub-Saharan African countries. The trial is being conducted by a number of international collaborating institutions and the results of the trial will determine the accuracy and clinical utility of the Rapid 1-2-3^® Hema Tuberculosis EXPRESS^® TB-XT and the Rapid 1-2-3^® Hema Tuberculosis EXPRESS^® TB-XT3 point-of-care tests as primary triage assays for the presence of active tuberculosis, or as part of a combination of tests used for that purpose.

The study, conducted as part of a long-term project for the control of HIV and related diseases in various Sub-Saharan countries, has been initiated by the Community of Sant’Egidio (www.santegidio.org) (http://dream.santegidio.org/?lang=en), an Italian Non-Governmental Organization, and sponsored by the Italian National Institute of Health. The scientific direction and the in-country clinic trial is being conducted specifically by The Department of Biomedicine and Prevention, University of Rome Tor Vergata and is headed by Professor Leonardo Palombi and Dr. Massimo Amicosante.

Also participating in this project is Fondazione Salvatore Maugeri, a non-profit Care And Research Institute, at its centre in Tradate, Italy (a World Health Organization Collaborating Centre for Tuberculosis and Lung Diseases) under the direction of Dr. G.B. Migliori.

The Rapid 1-2-3^® Hema Tuberculosis EXPRESS^® TB-XT and the Rapid 1-2-3^® Hema Tuberculosis EXPRESS^® TB-XT3 are point-of-care tests conducted with a single drop of whole blood, taken from a finger stick, with results available in 10-15 minutes. The TB-XT3 is an upgraded version of the original TB-XT and has a higher sensitivity and specificity rate. These assays were developed by Hema Diagnostic Systems in partnership with Lionex GmbH, Braunschweig, Germany. A research team headed by Prof. Mahavir Singh, President and CEO of Lionex, developed the proprietary lateral flow strips which are incorporated into the Hema Diagnostic System’s patented Express platform.

Tuberculosis is an age old scourge and continues to be a major cause of morbidity and mortality worldwide, affecting whole populations, national economies and individual communities. It is a huge public health burden in many countries. Fully one-third of humans on earth are infected with the tuberculosis organism. Most of these infections are latent or silent but there continues to be an onslaught of new active tuberculosis cases. The World Health Organization reported an estimated 10.8 million new cases in 2015 with 1.4 million deaths in non-HIV people and 390,000 more in those infected with HIV.

The WHO has recently implemented a program called “The END TB Strategy” which has as a goal the end of the TB epidemic in the next 20 years. Rapid diagnosis is a fundamental component of this goal and rapid diagnostic tools that perform accurately will become a major part of the “The END TB Strategy.”

We fully expect that the results of the clinical trial will place the Rapid 1-2-3^® Hema Tuberculosis EXPRESS^® TB-XT3 at the forefront of rapid non-molecular tuberculosis tests and that it will achieve accuracy rates acceptable for use on a worldwide basis for active tuberculosis diagnostic triage, either as a stand-alone test or in combination with other simple assays.

Dr. Harold G. Haines Ph.D., President and CEO of Hema Diagnostic Systems, recognized the importance of the clinical trial in the international effort to control tuberculosis by stating: “Hema Diagnostic Systems sincerely welcomes the opportunity to participate in this tuberculosis diagnostic clinical trial. We strongly value the expertise and eminence of the scientific, medical and corporate partners, each recognized international experts, in this cooperative endeavor, and look forward to a successful outcome of the study, along with progress towards ending the global tuberculosis epidemic.”

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