MIRAMAR, Fla.--(BUSINESS WIRE)--Hema Diagnostic Systems, LLC dba NuGenerex Diagnostics (www.hemadiagnosticsystems.com), a subsidiary of Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote), announced today the filing of a patent on its new diagnostic qualitative point-of-care platform, the Express II.
This Express II is designed to be used in both professional medical settings and for direct home use by consumers and can be employed for the detection of a wide range of analytes in whole blood samples obtained by a simple finger stick, or with plasma or serum samples in clinical laboratories. Analytes that can be measured by this new device include antigens or antibodies and protein biomarkers which are found in infectious diseases, metabolic diseases and in a host of other medical conditions.
The Express II has major advantages over other point-of-care devices because of its simplicity of use, which include fewer steps of operation, the elimination of loops or pipettes for transferring samples, the elimination of unnecessary sample pickup pads, and its ability to be utilized in professional settings, remote field use and for individual in-home use directly by consumers who can conduct the test by themselves in privacy. The results of any assay conducted using the Express II platform are available in 15-20 minutes, allowing clinical and therapeutic decisions to be made immediately and, if positive, appropriate patient counseling can be initiated on site.
NuGenerex Diagnostics plans to immediately use the Express II platform as the basis of its newly-developed Express II Syphilis Treponemal Antibody Assay, followed by the integration of its other infectious disease assays into the Express II.
Syphilis, once a disease on the decline, has reemerged as a major sexually transmitted disease. There is a current epidemic of syphilis in the United States and worldwide. The Centers for Disease Control and Prevention (CDC) reports a large increase in primary and secondary syphilis cases over the past few years, particularly in certain sections of the country (https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6444a3.htm) and recent media headlines have led to a greater public awareness for having high-risk groups periodically tested (https://www.statnews.com/2016/04/08/visualized-cdc-syphilis-rates/) (https://www.statnews.com/2016/03/01/syphilis-las-vegas/). Globally, cases of syphilis are increasing at a rapid pace. In particular, primary and secondary syphilis rates have dramatically increased in gay and bisexual men and in pregnant women, with a concomitant rise of congenital syphilis among newborns. The syphilis testing market currently makes up approximately 12-14% of the global STD diagnostic market. However, the syphilis infection rate is rising rapidly, and these infections are projected to rise to 20% of the market by 2022.
NuGenerex Diagnostics is on schedule to receive the CE mark for the Express II Syphilis Treponemal Assay in the Fall of 2018, which will allow marketing of the product in the European Union. The Company will also submit a 510(k) application to the FDA for marketing clearance in the US. At the same time, it will pursue regulatory clearance and partnering for marketing efforts in China.
Dr. Harold G. Haines Ph.D, President and CEO of NuGenerex Diagnostics, stated: “The current worldwide wave of syphilis poses a grave and serious threat to the health and well-being of millions of individuals. Control and treatment of this disease begins with rapid and accurate diagnosis. With the introduction of the Express II Syphilis Treponemal Antibody Assay, based on our patent-pending Express II platform, as a rapid diagnostic tool, we at NuGenerex Diagnostics hope to contribute to the immediate control and long-term goal of reduction and eventual elimination of this disease on a global basis.”
Dr. Jason B. Terrell MD, Chief Medical and Scientific Officer of Generex stated: “This is a great achievement and represents a major advancement of the NuGenerex Diagnostics point-of-care platform. I’m very proud of the team’s innovation and diligent work that made this a reality. I expect the Express II platform will not only have a short-term impact in the global diagnostics market but will also serve as the foundation for future innovations in rapid, point-of-care diagnostic technologies.”
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.