Profile: ERBA Diagnostics Inc (ERB.A)
24 Jun 2016
ERBA Diagnostics, Inc., incorporated on June 28, 1999, 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. The Company operates through two segments: the domestic region and the European region. The domestic region segment contains its subsidiaries located in the United States and in Latin American and corporate operations. The European region segment consists of the operations of its subsidiary located in Italy.
The Company is the parent of the following operating subsidiaries: Delta Biologicals, S.r.l. (Delta Biologicals), Diamedix Corporation (Diamedix), Drew Scientific, Inc. (Drew Scientific), ImmunoVision, Inc. (ImmunoVision) and JAS Diagnostics, Inc (JAS Diagnostics). Its 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 a range of technologies, including Enzyme Linked ImmunoSorbent Assay, or ELISA, technology, clinical chemistry, hematology and cell separation, as well as high performance liquid chromatography (HPLC) separations. The Company also designs and manufactures laboratory instruments that perform the tests. The Company's 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 also offers the Mago Plus 4 and Mago 4S instruments for the process ELISA and ImmunoFluorescent Assay, or IFA, simultaneously. The Company also develops, manufactures and markets raw materials, such as antigens used in the production of diagnostic kits. 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 products in the United States through certain independent distributors.
Delta, its European segment, from its facility, located in Pomezia, Italy, manufactures scientific and laboratory instruments, including its Mago 4, Mago 4S and Mago Plus systems, which include hardware, reagents and software. In Italy, Delta also sells other diagnostic products manufactured by third parties. Delta also serves as the distribution and support center for selling these same products to distributors located in other European and international markets outside of Italy.
Diamedix markets or distributes approximately 100 assays that the United States Food and Drug Administration, or FDA, has cleared. 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, or 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, or CMV, IgG, CMV IgM, Herpes Simplex Virus, or HSV, IgG, HSV IgM, Measles, Varicella Zoster Virus, or VZV, Lyme Disease, H. pylori, Mumps, six different Epstein-Barr Virus, or EBV, kits and others. In international markets, its line of autoimmune and infectious disease products is supplemented by additional products that are obtained from third party companies.
The Company's Escalon Clinical Diagnostics Business consists of Drew Scientific, and its wholly owned subsidiaries JAS Diagnostics and Drew Scientific Limited Co. Drew Scientific is a diagnostics company specializing in the design, manufacture and distribution of instruments for blood cell counting and blood analysis. Drew Scientific is focused on providing instrumentation and consumables for physician office and veterinary office laboratories. Drew Scientific also supplies the reagent and other consumable materials needed to operate the instruments. Drew Scientific sells diabetic testing products including the DS5 instrument, dispenser and associated reagent kit, which measure long-term glucose control in diabetic patients (HbA1c). Additionally, Drew Scientific offers an array of equipment for use in the field of human and veterinary hematology. Drew Scientific's Excell product lines are for use in the field of human hematology, and its Hemavet product line is for use in the veterinary field. Drew Scientific has facilities located in Waterbury, Connecticut, and Dallas, Texas.
ImmunoVision is developing, manufacturing and marketing 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. JAS Diagnostics is engaged in the manufacture of a range of liquid stable, diagnostics chemistry reagents used for in vitro diagnostics testing. JAS Diagnostics' reagents are sold through distributors and directly to end users customers, including physician, reference, hospital and veterinary diagnostic testing laboratories. JAS Diagnostics has general chemistry reagents that can be used on numerous open system chemistry instrument analyzers. Additionally, JAS Diagnostics' reagents are marketed for use as instrument specific reagent lines, such as in instrument reagent containers and bar coded for use on the Olympus 400 and 600 series, Mindray BS-200 and Alfa Wassermann ACE/ALERA chemistry analyzers, among others.
The Company competes with Bio-Rad Laboratories, DiaSorin, INOVA, Alere, Meridian Bioscience and The Binding Site.
ERBA Diagnostics Inc
2140 N Miami Ave
MIAMI FL 33127-4916