Miramar, Florida – Hema Diagnostic Systems, located in Miramar, Florida USA, a subsidiary of Generex Biotechnology Corporation (www.generex.com) (OTCPINK:GNBT), has announced its’ intention to develop a new and novel multiplex assay designed for use with Sepsis. Given the preliminary designation of RAPID 1-2-3® HEMA SEPSIS, the team development is a coordinated effort involving both Hema Diagnostic Systems and Generex Biotechnology.

Sepsisis a complex clinical syndrome of inflammatory dysregulation in response to infection. It is found primarily in hospital settings and is a major cause of disease and death in the United States and worldwide. Over 1 million people every year are afflicted by this syndrome in the US alone. It has been estimated that between 28-50% of these patients die. (National Center for Health Statistics Data Brief No. 62 June 2011. Inpatient care for septicemia or sepsis: a challenge for patients and hospitals).

The market for diagnostic sepsis tests in the United States alone is $36 million in 2016 and expected to reach $564 million by 2021. (Sepsis Diagnostics Market by Technology (Molecular Diagnostics, Microbiology,Immunoassay), Product (Instrument, Blood Culture Media), Method (Conventional & Automated, Usability (Laboratory & POC), Pathogen (Bacterial & Fungal) - Global Forecast to 2021), published by Markets and Markets. Sepsis is a rapidly-developing life-threatening condition and a leading cause of hospital deaths in the US and abroad. Early assessment and management is the key to improving survival rates. Because of the rapid development and progression of sepsis, there is an unmet clinical need for a diagnostic test that will allow physicians to accurately assess at patient’s status in a matter of minutes.

Using its proprietary diagnostic platform HDS is developing a quantitative, multiplex, rapid point-of-care diagnostic assay for direct bedside use by physicians and medical personnel to evaluate a patient’s current status within the sepsis syndrome. The results of this assay will be available in 15-20 minutes.

This multiplex assay will be a rapid result diagnostic tool providing physicians with quantifiable biomarker based data to assess and monitor a patient’s current status and likelihood of progression within sepsis syndromes. As such, it is a multi-purpose diagnostic assay.

This assay will be based on the detection of biomarkers, usually proteins, which are normally produced in the body under sepsis conditions. The detection of multiple biomarkers in sepsis patients and their quantitation will also allow the physician to closely monitor the development of the sepsis syndrome in real-time and to aid in determining the overall effects of treatment choices and to alter treatment, if necessary.

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