Sept. 7, 2010
-- Panama City, Panama, January, 2010 – Hema Diagnostic Systems Panama, S.A. (HDS) announced today the launch of the QUANTI-FLEXX®
SURE™ ELISA. The ELISA will be sold for Research Use.
SURE™ ELISA is based upon a highly effective diagnostic technology which incorporates a series of unique antigens, and which has successfully produced favorable evaluations in clinical testing. Results of two independent evaluations conducted in Africa, using known positive and negative TB specimens, confirmed that the QUANTI-FLEXX®
SURE™ ELISA is an excellent tool to determine the presence of active mycobacterium Tuberculosis (mTB) in humans. It may also be used as an adjunct to current testing processes to aid in the diagnosis of individuals with active tuberculosis disease. It is also non-reactive to BCG.
Lawrence Salvo, President and CEO of Hema Diagnostic Systems stated in announcing the new diagnostic that: “the QUANTI-FLEXX®
SURE™ ELISA represents a new and novel step in determining the absence or presence of active mTB in a patient. This has proven to be, for many years, an extremely difficult task to determine with a degree of confidence.”
Mr. Salvo further stated that “the QUANTI-FLEXX®
SURE™ ELISA includes antigens which primarily diagnose the active disease. We have found no other immunological tests that can currently do this. For example, well known tests presently used in Tuberculosis diagnostics can detect the infection as well as TB disease but cannot differentiate latent from active disease. Data until now shows that the QUANTI-FLEXX®
SURE™ ELISA is highly specific to TB disease and does not react or react with a very low sensitivity to the so-called LTBI people- who are otherwise healthy. This is a major advantage for the QUANTI-FLEXX®
SURE™ ELISA since infection rates are very high in locations such as Africa and there is no point to diagnose LTBI (Latent Tuberculosis Infection) cases which involve healthy individuals who are asymptomatic.
SURE™ ELISA will be sold in the United States under “Research Use” as well as in Europe and around the world. It is an approved product under the European Union CE mark process and will have instructions available in English, Spanish, Portuguese and French. Also available in the near future will be instructional packages in both Russian and Arabic.
About Hema Diagnostic Systems
Hema Diagnostic Systems Panama, S.A. (www.rapid123.com)
is a rapidly growing biotechnology company 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 and a new and growing line of ELISA assays, 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’ patented and patent pending delivery systems. The Rapid 1-2-3 Hema EXPRESS®as well as the Rapid 1-2-3 Hema EZ® are novel delivery systems that are self contained and easy to use. HDS offers ELISA assays under HDS’ QUANTI-FLEXX®
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.
# # #
Manufacture and distribute rapid diagnostic and elisa tests for infectious diseases around the world. Targeting ngo, fbo and ministries of health throughout africa and south and central america as well as europe.