GNBT Generex Biotechnology Corp

Generex Announces Order for Hema Diagnostic Systems’ Rapid 1-2-3® Hema HIV EXPRESS® in Chile

Generex Biotechnology Corporation (OTC Pink:GNBT) (www.generex.com) today announced that its subsidiary, Hema Diagnostic Systems LLC (www.hemadiagnosticsystems.com), has received an initial order for its Rapid 1-2-3® Hema HIV EXPRESS® from Diagnostiko Ltda. (www.diagnostiko.cl) in Chile.

Diagnostiko is a clinical testing laboratory serving the residents of Santiago, Chile and surrounding areas. Chile has an increasing number of cases of HIV and AIDS and is in need of reliable and quick diagnostic assays. As reported by the Latin American Congress of HIV in June, 2017, there was an increase in the number of cases of HIV in Chile of nearly 50% from 2010 to 2015 and, more significantly, 60% of those cases are diagnosed very late in the course of the disease, many after AIDS has already developed. Another issue highlighted in the Congress is the current lack of availability of rapid tests to detect newly-acquired HIV infections.

Rapid point-of-care testing is a crucial need of HIV diagnosis since it allows immediate assessment and treatment of positive cases, as compared to longer traditional laboratory tests. The General Manager of Diagnostiko, Astrid Faba, plans to fill that gap by immediately using the Rapid 1-2-3® Hema HIV EXPRESS® for diagnosis of HIV infection in her laboratory. This assay, which has a diagnostic accuracy of over 99%, has been previously registered and approved for sale by the Chilean Ministry of Health

In addition to procuring the Rapid 1-2-3® Hema HIV EXPRESS®, Diagnostiko has also agreed to officially register the Rapid 1-2-3® Hema Hepatitis B EXPRESS®, and the Rapid 1-2-3® Hema Syphilis EXPRESS® with the government of Chile, and to become the exclusive distributor for those two assays in that country for future sales.

Dr. Harold G. Haines Ph.D., the President and CEO of Hema Diagnostic Systems, acknowledged the cooperation of Diagnostiko in purchasing the Rapid 1-2-3® Hema HIV EXPRESS®, and in registering the Hepatitis B and Syphilis rapid assays by stating: “We are pleased and delighted to have Diagnostiko as an experienced and capable testing and distribution partner in Chile, and see this as the start of a productive and beneficial relationship, for both partners, and for the people of Chile.”

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

EN
12/09/2017

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