Seeking immunosimplicity

MIAMI—IVAX Diagnostics' U.S. subsidiary Diamedix Corp. has signed a distribution agreement with Fumouze Diagnostics, a division of Sofibel SAS of Paris, France, granting Fumouze exclusive third-party distributor rights in France to Diamedix's and Delta Biologicals SRL's suite of diagnostic tests. Delta Biologicals is IVAX Diagnostics' subsidiary located in Italy. The initial term of the distribution agreement is three years.

Diamedix was created as a result of the merger in 2001 between b2bstores.com Inc. and the diagnostic business subsidiary within IVAX Corp. In 2006, IVAX was merged into a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. As a result of this merger, Teva, indirectly through its IVAX subsidiary, owned approximately 72 percent of IVAX Diagnostics. In September 2008, a group controlled by two experienced international medical diagnostics and pharmaceutical industry entrepreneurs, Paul Kennedy and Patrice Debregeas, purchased all of the shares of IVAX Diagnostics common stock owned by Teva.

IVAX Diagnostics consists of Diamedix and its sister companies, Delta Biologicals SRL and ImmunoVision Inc., and Delta Biologicals, a laboratory instrumentation and software company, developed the recently introduced Mago 4S EIA Analyzer that is used in conjunction with the new Diamedix immunosimplicity (Is) Test Kits.

"Our other affiliate ImmunoVision is a world leader in antigen production for autoimmune testing and provides us with the critical raw materials that form the foundation for many of our tests," notes Diamedix president and CEO Dr. Charles Struby. "These affiliations have allowed us the unique opportunity to design our own superior quality test kits and to produce a single integrated reagent system with our EIA instrumentation and software. The immunosimplicity products consistently incorporate overall increased sensitivity and specificity with improved ease-of-use and quality reagent formulations, all of which combine to provide reliable, accurate results with even greater efficiency and cost effectiveness."

Although the products may be assayed manually, he notes, their intended use is in tandem with the Diamedix instrumentation, which provides true "walkaway" capability. As a further assurance of product and instrument performance, Diamedix tests are FDA cleared through the 510(k) process for both manual and automated methods, and comparable results (as seen in the package inserts) have been obtained for each method and for all tests.

The Fumouze relationship is the first of several planned by Struby to secure distribution in Germany, Spain and the united Kingdom, as well as France and Italy.

"We expect that our distribution agreement with Fumouze Diagnostics will open the French market to Diamedix and Delta Biologicals' suite of more than 200 diagnostic tests and will be a major step towards attaining our goal of expanding our product reach in Europe," Struby says.

He notes that Diamedix is edging close to $20 million in annual sales, and is debt-free with about $10.8 million in cash and receivables. In addition to expanded distribution in Europe, the company plans to move into India and China as soon as practicable.

The worldwide in vitro diagnostics market is projected to grow from $41 billion in 2007 to $67 billion in 2013, Struby says, with emerging markets experiencing 10 to 20 percent annual growth, compared with 3 to 6 percent for the rest of the world. An aging world population and expansion of testing to physician office and home settings are other growth drivers, Struby notes.

To support the sales efforts in France under the distribution agreement, Fumouze Diagnostics has agreed to hire a sales representative to sell Diamedix and Delta Biologicals' products in collaboration with Fumouze Diagnostics' existing direct sales force. Diamedix and Delta Biologicals have a combined suite of products that includes more than 200 diagnostics tests in the areas of infectious disease, autoimmune disease and allergies.