IVAX Diagnostics, Inc. Signs Distribution Agreement with Augurix SA for the First Approved Rapid Test for Celiac Disease

MIAMI--(BUSINESS WIRE)--IVAX Diagnostics, Inc. (AMEX:IVD - News), a fully integrated in vitro diagnostics company, has signed a distribution agreement with Augurix SA for Simtomax® Blood Drop, the first one-step rapid test that accurately diagnoses celiac disease in all patients. Celiac disease, also known as gluten intolerance, is a food intolerance to three cereals widely present in food, wheat, barley and rye that afflicts about 1% of the global population. The prevalence and incidence of the disease in the key markets covered by the agreement (i.e., France, Germany, Italy, Spain and the U.K) exceeds 1 million and 31,000 people, respectively.

As part of the agreement, IVAX Diagnostics will distribute Simtomax Blood Drop through its Delta Biologicals division to doctors in countries that include Italy, UK, France, Spain, Germany, Portugal, the Netherlands, Belgium, Greece, Romania, Turkey and Saudi Arabia. Patients will be able to detect the presence of the disease within ten minutes. Simtomax Blood Drop is the first one-step rapid test that accurately diagnoses celiac disease in all patients, including the 10% presenting a selective immunoglobin A deficiency.

Dr. Charles Struby, CEO of IVAX Diagnostics said, “This agreement with Augurix reflects our mission to create a stronger and more competitive company by distributing test kits for autoimmune diseases that meet and/or exceed patients’ and their physicians’ needs for accurate and efficient in vitro diagnosis for autoimmune diseases. In line with our mission, we believe the Simtomax Blood Drop offers the best, most efficient and accurate test for celiac disease. Augurix’s patented Simtomax platform is a unique and novel immunochromatography-based technology that allows for several analyses to be performed simultaneously. The test is easy to use, requires no medical skills or training, is non-invasive and provides rapid and clear results, all factors that add to its appeal for screening.”

He added, “Our sales force in Europe and Asia will help place this test into the hands of doctors and ultimately patients who can benefit from detection of celiac disease, which is considered to be the most under-diagnosed condition in the world. Augurix has developed an effective platform technology, and we look forward to partnering with them to make their product available to patients who are afflicted with celiac disease.”

About Augurix SA

Augurix SA, www.augurix.com, develops, manufactures and markets disposable, pocket-size medical devices for rapid screening purposes for both the medical community and the public at large. Based in Switzerland, the company was incorporated in 2007 in Geneva. Augurix’ first product line, Simtomax®, which diagnoses and monitors intolerance to gluten (also known as “Celiac Disease”), matches the gold standard in only ten minutes. It can be operated by anyone, anywhere: no medical training is necessary. Augurix’ patented lateral flow technology enables large scale screening and monitoring campaigns. The company has strong research and development activities and intellectual property pipelines.

About IVAX Diagnostics, Inc.

IVAX Diagnostics, Inc. (www.ivaxdiagnostics.com), headquartered in Miami, Florida, is a fully integrated in vitro diagnostics company that develops, manufactures and distributes in the United States and internationally, proprietary diagnostic reagents, test kits and instrumentation, primarily for autoimmune and infectious diseases, through its three subsidiaries: Diamedix Corporation, Delta Biologicals S.r.l. and ImmunoVision, Inc.

Safe Harbor Statement

Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect the business and prospects of IVAX Diagnostics, Inc., including, without limitation: the risks and uncertainties associated with IVAX Diagnostics’ strategic initiatives, including, without limitation, that IVAX Diagnostics may not successfully implement some or all of its strategic initiatives and that its strategic initiatives may not make IVAX Diagnostics a stronger, larger or more competitive company, allow IVAX Diagnostics to successfully capitalize on being one of the few fully integrated in vitro diagnostics companies, result in an improved manufacturing process for IVAX Diagnostics or increase IVAX Diagnostics’ operational efficiency and/or competitiveness in the marketplace; the risk that IVAX Diagnostics may not develop, manufacture and distribute worldwide, reagents, test kits and diagnostic equipment that meet and/or exceed patients’ and their physicians’ needs for accurate and efficient in vitro diagnosis; the risk that IVAX Diagnostics may not expand its product offerings for autoimmune and infectious diseases, whether internally or through collaborations with distributors in the U.S. and Europe; the risk that IVAX Diagnostics’ strategic review of its businesses may not result in IVAX Diagnostics’ strategy being better refined or improve IVAX Diagnostics’ operations and the risk that the expenses incurred and to be incurred in connection with such review may impact IVAX Diagnostics’ financial condition, operating results and cash position; the risk that IVAX Diagnostics’ may not expand its current testing platform and/or disease target areas and the risk that IVAX Diagnostics’ operating results and competitive position may not improve even if its current testing platform and/or disease target areas are so expanded; the risk that IVAX Diagnostics’ financial condition, operating results and competitiveness may not improve as a result of or otherwise benefit from the reorganization of IVAX Diagnostics’ U.S. operations to create a more synergized workflow by eliminating organization silos; the risks and uncertainties relating to the healthcare industry in general and IVAX Diagnostics’ position within the healthcare industry, including, without limitation, the risk that the healthcare industry may not continue to grow at the rate IVAX Diagnostics anticipates, or at all, the risk that IVAX Diagnostics’ role in proper disease management may not increase even if the healthcare industry continues to grow and/or as a result of the continued aging of the global population, the risk that a shift to personalized medicine may not occur or, if it does so occur, the risk that IVAX Diagnostics may not benefit from that shift; the risk that there may not be an increased demand for improved diagnostic capabilities or, if there is such an increase, the risk that such increase may not positively impact IVAX Diagnostics’ long-term performance, whether as a result of IVAX Diagnostics’ initiatives to improve its operations or otherwise; the risks and uncertainties associated with existing global economic conditions, including, without limitation, that IVAX Diagnostics’ operating results, and net revenues in particular, may continue to be adversely impacted if existing global economic conditions do not improve and that any such impact may be significant and have a long-term effect on IVAX Diagnostics and its financial condition, operating results and cash position; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. In addition to the risks and uncertainties set forth above, investors should consider the economic, competitive, governmental, technological and other risks and uncertainties discussed in IVAX Diagnostics’ filings with the Securities and Exchange Commission, including, without limitation, the risks and uncertainties discussed under the heading “Risk Factors” in such filings.

Contact:

IVAX Diagnostics, Inc.: Dr. Charles R. Struby, 305-324-2300 CEO & President or Investor Relations: Porter, LeVay & Rose, Inc. Linda Decker, 212-564-4700 Vice President