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

Hema Diagnostic Systems (HDS) Announces the Final Validation Process of a New Anthrax Toxin Rapid Test for the Detection and Differentiation Between the Anthrax Protective Antigen (PA) and the Lethal Factor (LF) Using Whole Blood or Serum

MIRAMAR, FL / ACCESSWIRE / October 15, 2015 / 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(R) Express(R) 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 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(R) 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.

SOURCE: Hema Diagnostic Systems LLC

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