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Generex Subsidiary Hema Diagnostic Systems, LLC dba NuGenerex Diagnostics Announces Filing of a European CE Marking Application

September 20, 2018

Generex Subsidiary Hema Diagnostic Systems, LLC dba NuGenerex Diagnostics Announces Filing of a European CE Marking Application

Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that its subsidiary, Hema Diagnostic Systems, LLC dba NuGenerex Diagnostics (www.nugenerexdiagnostics.com), has filed an application for European Economic Area (EEA) CE Marking of its newly developed point-of-care platform, the Express II, in respect of the commercialization of the device for the rapid testing of syphilis antibodies as part of international diagnostic testing algorithms. This platform offers simplicity of diagnostic testing in a variety of settings. The Express II platform is simple enough for an individual to self-administer in privacy and can streamline care in the professional medical setting. The Company previously announced the filing of a provisional patent for the Express II.

CE Marking signifies that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements and ensures free movement of products within the 30 EEA countries. This new assay, named the NGDx-Express Test for Syphilis Antibodies, is a rapid self-contained test for the qualitative detection of syphilis treponemal antibodies in human whole blood, serum, or plasma, and can be used to accurately diagnose primary, secondary, and latent syphilis in conjunction with clinical signs, patient history, and other laboratory assays.

Currently, syphilis is in epidemic proportions in most countries in the world and is continuing to rise in many areas. This epidemic is being driven by transmission of the syphilis organism, Treponema pallidum, in male-to-male sexual activity, sex workers, and other high risk groups. Of particular importance is the widespread increase of syphilis in newborn infants after acquisition from an infected mother. The early and rapid testing and treatment of both the mother and the infant significantly decreases the serious effects of syphilis in the infant and reduces long-term disabilities.

The NGDx-Express Test for Syphilis Antibodies is designed to be used in medical settings such as university clinics, urgent care centers, walk-in clinics, physician offices, public health clinics and any medical setting which utilizes rapid testing procedures. The preferred sample is a single drop of blood obtained by a finger stick (or a heel-prick in newborns), but the test can also be performed with serum or plasma samples in laboratories with results available in 15-20 minutes.

The NGDx-Express Test for Syphilis Antibodies, based on the patent-pending Express II platform, is also designed to be used for direct home use by consumers in countries where self-testing is permitted. For self-administered testing, a drop of blood is obtained by a simple finger stick and placed directly onto the device after which a diluent pod containing development buffer is placed on the device.

Traditional syphilis diagnostic algorithms utilize assays such as RPR (Rapid Plasma Reagin) or VDRL (Venereal Disease Research Laboratory). These non-treponemal assays are non-specific and, if positive, do not always indicate that the tested patient has syphilis. As such, a positive RPR or VDRL assay must be followed by confirmatory laboratory testing which is time consuming and expensive. Newer “reverse syphilis diagnostic algorithms” utilize the detection of Treponema pallidum treponemal antigens as a diagnostic indicator of syphilis infection. The detection of highly specific treponemal antigens is indicative of either primary syphilis, secondary syphilis, or latent syphilis and positive patients can be treated accordingly based on the results of these assays.

The NGDx-Express Test for Syphilis Antibodies is based upon the detection of antibodies to treponemal antigens, and is therefore highly specific and ideally suited for inexpensive and rapid point-of-care diagnosis of syphilis with results ready in 15-20 minutes.

Dr. Harold G. Haines, PhD, President of NuGenerex Diagnostics, stated: “We are pleased to announce this EEA regulatory filing for the NGDx-Express Test for Syphilis Antibodies. With this initial filing we can now embark on the process of entering the European market with this assay as an integral part of the international effort to combat rising syphilis infections in all parts of the world. We are also beginning the process of FDA 510k regulatory compliance and the Clinical Laboratory Improvement Amendments (CLIA) which will allow us to enter the US market with our unique rapid syphilis assay.”

Dr. Jason B. Terrell MD, Chief Medical and Scientific Officer of Generex stated: “The syphilis epidemic is a major worldwide public health concern. The filing for CE Marking represents a critical advancement in commercialization and we are now one step closer to delivering this much needed test to millions of patients across the world.”

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.