DESCRIPTION OF IVAX DIAGNOSTICS' BUSINESS
General. IVAX Diagnostics is a wholly-owned subsidiary of IVAX. IVAX incorporated IVAX Diagnostics in 1996 to be the parent corporation of the following three subsidiaries:
. Diamedix Corporation;
. Delta Biologicals, S.r.l.; and
. ImmunoVision, Inc.
Through these subsidiaries, IVAX Diagnostics develops, manufactures, and markets diagnostic test kits or assays that are used to aid in the detection of disease markers primarily in the areas of autoimmune and infectious diseases. These tests, which are designed to aid in the identification of the causes of illness and disease, assist physicians in selecting appropriate patient treatment. Most of IVAX Diagnostics' tests are based on Enzyme Linked ImmunoSorbent Assay (ELISA) technology, a clinical testing methodology used worldwide. Specific tests are prepared using a 96 well microplate format whereby specific antigens are typically coated on the wells of a microplate during the manufacturing process. A test using ELISA technology involves a series of reagent additions to the microplate causing a reaction that results in a visible color in the wells. The amount of color is directly proportionate to the amount of the specific analyte in the patient sample. IVAX Diagnostics' kits are designed to be performed either manually or in an automated format. In addition to an extensive line of diagnostic kits, IVAX Diagnostics also designs and manufactures laboratory instruments that perform the tests and provide fast and accurate results, while reducing labor costs. This proprietary instrument, named the Mago system, includes a fully-automated Elisa processor operating with IVAX Diagnostics' own user-friendly software, allowing customers to perform tests in an automated mode. IVAX Diagnostics also develops, manufactures, and markets raw materials, such as antigens used in the production of diagnostic kits. |
