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DUBLIN, Ireland -- Trinity Biotech plc announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its CAPTIA HSV IgG Type Specific ELISAs in the United States.
These products are approved for the detection of IgG antibodies to HSV 1 & 2 in human serum and are among the first HSV type specific ELISAs to be FDA cleared. In the past, HSV serological testing has been limited by the inability of assays to distinguish between antibodies to HSV-1 and HSV-2. The CAPTIA HSV type specific ELISAs use recombinant glycoproteins gG-1 and gG-2, which are type specific for HSV-1 and HSV-2 antibodies respectively. These glycoproteins accurately differentiate between antibodies to HSV-1 and HSV-2 and considerably decrease or eliminate any potential cross reactivity.
CAPTIA HSV type specific ELISAs were cleared by the FDA on the basis of clinical trial results on more than 900 patient specimens where the products demonstrated a test sensitivity of 100 percent and a specificity of 99 percent in specific patient populations. HSV is a chronic disease that infects more than 1 billion people worldwide. HSV-1 is commonly associated with oral herpes and HSV-2 with genital herpes, although both have been shown to affect either area. According to the Centers for Disease Control and Prevention (CDC), 45 million people in the United States are infected with HSV-2, with an estimated 500,000 new cases occurring annually. Previously HSV did not receive much attention for eradication as it was not considered an "emergency" disease since it is not typically life-threatening except in the rare incidence of neonatal herpes infection. This view has been altered radically because of the increasing association of HIV transmission within HSV-infected patients. The direct medical costs associated with HSV-2 infections in the United States were estimated to be $1.9 billion in 2003 and it is projected to rise to $2.5 billion in the next decade.
Trinity Biotech believes that their HSV Type Specific ELISAs, allowing the differentiation between HSV-1 and 2, are an important diagnostic tool and will provide physicians with the information necessary to establish treatment options and initiate appropriate patient counseling. It is hoped that these tests will form part of the public health armory against the continually increasing HSV epidemic in the United States.
Commenting on the FDA clearance, Ronan O'Caoimh, CEO said: "We are very pleased with the FDA's decision to clear our CAPTIATM HSV type specific ELISAs. This further strengthens our position in the U.S. market as a leader in sexually transmitted disease diagnosis and greatly complements our existing MicroTrakÂ® product line. Trinity Biotech has been successfully supplying the U.S. market with our CAPTIATM ELISAs for the past 10 years and has the experience necessary to meet the expected demand in the United States for this product. We will market the product in the United States using our own established direct sales force."
Trinity Biotech develops, acquires, manufactures and markets more than 500 diagnostic products for the point-of-care and clinical laboratory segments of the diagnostic market. The broad line of test kits are used to detect infectious diseases, sexually transmitted diseases, blood coagulation disorders, and autoimmune diseases.
Source: Trinity Biotech