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, 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.