ERBA Diagnostics, Inc., through its subsidiaries, develops, manufactures, and markets diagnostic test kits or assays, and automated systems that are used to aid in the detection of disease markers primarily in the areas of autoimmune, infectious diseases, clinical chemistry, hematology, and diabetes testing. Subsidiaries The company’s subsidiaries include Delta Biologicals, S.r.l.; Diamedix Corporation; Drew Scientific, Inc.; ImmunoVision, Inc.; and JAS Diagnostics, Inc. Business The company’s tests, which are designed to aid in the identification of the causes of illness and disease, assist physicians in selecting appropriate patient treatment. The company’s tests are based on various technologies, including Enzyme Linked ImmunoSorbent Assay (ELISA) technology, clinical chemistry, hematology and cell separation, as well as HPLC separations, all of which are clinical testing methodologies used worldwide. The company also designs and manufactures laboratory instruments that perform the tests and provide fast and accurate results. The company’s existing proprietary instruments, named the Mago 4, Mago 4S, and Mago Plus systems, include a fully-automated ELISA processor operating with its own software, which allows customers to perform tests in an automated mode. The company updated the Mago Plus 4 and Mago 4S instruments to include the capability to process ELISA and ImmunoFluorescent Assay (IFA) simultaneously. The company also develops, manufactures, and markets raw materials, such as antigens used in the production of diagnostic kits. The company’s autoimmune product line consists of approximately 50 ELISA test kits and approximately 50 IFA assays that the FDA has cleared. These products include test kits for screening antinuclear antibodies and specific tests to measure antibodies to dsDNA, SSA, SSB, Sm, Sm/RNP, Scl 70, Jo-1, Rheumatoid Factor, MPO, PR-3, TPO, TG, and others. These products are used for the diagnosis and monitoring of autoimmune diseases, including Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis, Mixed Connective Tissue Disease, Sjogren’s Syndrome, Scleroderma, and Dermatopolymyositis. The company’s infectious disease product line, together with kits obtained from third party companies, includes approximately 30 kits that the FDA has cleared, including Toxoplasma IgG, Toxoplasma IgM, Rubella IgG, Rubella IgM, Cytomegalovirus (CMV), IgG, CMV IgM, Herpes Simplex Virus (HSV), IgG, HSV IgM, Measles, Varicella Zoster Virus (VZV), Lyme Disease, H. pylori, Mumps, six different Epstein-Barr Virus (EBV), kits and others. In international markets, this line of autoimmune and infectious disease products is supplemented by additional products that are obtained from third party companies. The company sells diabetic testing products, including the DS5 instrument, dispenser and associated reagent kit, which measure long-term glucose control in diabetic patients (HbA1c). Additionally, the company offers an array of equipment for use in the field of human and veterinary hematology. The company develops, manufactures and markets autoimmune reagents and research products for use by research laboratories and commercial diagnostic manufacturers. These manufacturers (including Diamedix) use these antigens to produce autoimmune diagnostic kits. The company specializes in the manufacture of a range of liquid stable, diagnostics chemistry reagents used for in vitro diagnostics testing. Its reagents are sold through distributors and directly to end users customers – physician, reference, hospital and veterinary diagnostic testing laboratories. Research and Development The company incurred $1,412,000 in 2014 for research and development activities. Sales and Marketing The company markets its products in the United States through its own sales force to hospitals, reference laboratories, clinical laboratories and research laboratories, as well as to other commercial companies that manufacture diagnostic products. It also distributes its products in the United States through certain independent distributors. The company sells some of its products to pharmaceutical and biotechnology companies as well. The company markets its products in certain international markets through a network of independent distributors. The company markets and sells its products in Italy through Delta’s sales representatives and independent agents, who are restricted from selling competing products. The company also sells its products in other global markets through a number of independent distributors. The company’s marketing and technical service departments located in Miami Lakes, Florida, Springdale, Arkansas and Pomezia, Italy support their efforts. The products the company markets in the United States are purchased principally by healthcare providers that bill third party payors, such as governmental programs, private insurance plans and managed care plans, for healthcare services provided to their patients. Competition The company’s competitors include Bio-Rad Laboratories, DiaSorin, INOVA, Alere, Meridian Bioscience, and The Binding Site. History ERBA Diagnostics, Inc. was founded in 1980.
erba diagnostics inc (ERB:NYSE Amex)
2140 North Miami Avenue
Miami, FL 33127
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