Hema Diagnostic Systems, L.L.C. Announces the Final Validation Process for a New Rapid Anthrax Ab Test

Miramar, FL, October 15, 2015 (Newswire.com) -  Hema Diagnostic Systems, LLC, a US based medical device company, announced today in Miramar, Florida, the final evaluation phase of its’ new rapid, whole blood/serum tests, officially designated as the  Rapid 1-2-3 Hema®  Express®  Anthrax Ab test.

 According to Lawrence Salvo, President and CEO of Hema Diagnostic Systems, “The development and completion of the new Rapid 1-2-3 Hema Express Anthrax Ab diagnostic will make available, the very first rapid Anthrax Ab whole blood test that can deliver accurate, reliable and repeatable testing for the anthrax toxins of PA and LF, in the field and with a very high degree of sensitivity and specificity. Test results are read in 15 minutes from the start of the test process…. the diagnostic can also be used with serum for laboratory processes”  Additionally, Salvo said:  “with the potential funding and partnership that HDS anticipates from Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT), we see a substantial opportunity to expand the commercialization of this product, especially here in the United States. Other current HDS products as well as those future devices presently in various stages of research and development, will also benefit from this growing relationship.”

"The development and completion of the new Rapid 1-2-3 Hema Express Anthrax Ab diagnostic will make available, the very first rapid Anthrax Ab whole blood test that can deliver accurate, reliable and repeatable testing for the anthrax toxins of PA and LF, in the field and with a very high degree of sensitivity and specificity. "

Lawrence Salvo, President and CEO of Hema Diagnostic Systems

The new and novel Rapid 1-2-3 Hema Express Anthrax Ab has been developed to detect and differentiate the Anthrax Toxins of Protective Antigen (PA) and the Lethal Factor (LF) through either whole blood from a finger stick and capable of being performed in a clinic or in-field, as well as the use of serum in a laboratory procedure. Separate and individual Test (“T1 and T2”) lines have been assigned to each of the two Anthrax Toxins for separate and individual confirmation of the presence of either/or, or both.  Additionally, a Control (“C”) line has been added on the test strip to confirm to the user that once the test process has started, the test is operational.

Sensitivity and specificity has been determined using existing in-house Quality Control ELISA panels. Following multiple test and batch evaluations, sensitivity was determined to be 100% and specificity at 99.6%. The device delivered continuing high performance, with significant repeatability.  

Storage is set at 2°C-30°C with an initial designated shelf life of 18 months, and with the intention to increase shelf life as additional stability testing progresses over the next many months. Additional testing is being undertaken on a Real Time and Accelerated Stability basis, at higher temperatures.

The Rapid 1-2-3 Hema Express Anthrax Ab will be offered in the easy-to-use Rapid 1-2-3 Hema Express® housing which has been designed to be user-friendly and which reduces the opportunity of cross-infection through user-error and/or improper control of the potentially positive whole blood/serum sample.

Based upon the current timeline, it is anticipated that initial regulatory processes will be completed by January 2016.

About Hema Diagnostic Systems

Hema Diagnostic Systems LLC (www.rapid123.com) is a rapidly growing, U.S. based biotechnology company, that is involved in the development, manufacture, assembly and distribution of diagnostics targeting primary as well as orphan infectious diseases. Incorporating rapid, Point-Of-Care test devices, Hema Diagnostic Systems continues to expand its product line to meet the needs of the worldwide market. Point-of-Care test devices are made simple to use and are highly cost effective when incorporated into Hema Diagnostic Systems delivery systems. The Rapid 1-2-3 Hema EXPRESS and EXPRESS-II are new and novel delivery systems that are self-contained and easy to use.

This release may contain forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ, and such differences could be material. Such risks and uncertainties include, but are not limited to, the following: continued acceptance of the Company's products, increased levels of competition in our industry, the acceptance of new products, inherent risks associated with product development and intellectual property rights, the Company’s dependence on key personnel, third party sales and suppliers. There can be no assurance that the Company will be successful in addressing such risks and uncertainties and the Company assumes no duty to update any forward-looking statements based upon actual results.

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