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OraSure Technologies Announces Pre-Clinical Study Results for Prototype Rapid HCV Antibody Test at AACC Annual Meeting
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- Prototype Test Performance Equivalent to Lab-Based Testing in Pre-clinical Trials of Human Subjects -
BETHLEHEM, Pa.--(BUSINESS WIRE)--OraSure Technologies, Inc. (NASDAQ:OSUR), the market leader in oral fluid diagnostics, today announced pre-clinical study results for a prototype rapid Hepatitis C ("HCV") antibody test on the Company's OraQuick test platform, using oral fluid, finger-stick whole blood, venous whole blood, serum and plasma samples. These results were reported by OraSure at the 2007 Annual Meeting of the American Association of Clinical Chemistry held in San Diego, California.
In pre-clinical studies conducted by the Company, performance of the prototype HCV test for all specimen types was shown to be equivalent to or better than results obtained from currently available, state of the art laboratory-based enzyme immunoassay tests using serum and plasma specimens. Additional information regarding the preclinical study results presented by OraSure at the ACC Annual Meeting can be found at www.orasure.com/aacc.
"We are very pleased with the pre-clinical results generated by our prototype OraQuick rapid HCV antibody test," said Douglas A. Michels, President and CEO of OraSure Technologies. "Our development efforts are proceeding on schedule, and we intend to begin the final clinical studies required to obtain FDA approval during the next several months. Our plan is to complete these studies as soon as possible and file an application for FDA approval in early 2008. Assuming we are successful, we expect that our test will be the first rapid HCV antibody test approved by the FDA for use in the United States."
Prospective pre-clinical testing of 419 low-risk human subjects using oral fluid, finger stick and venous whole blood, serum and plasma, generated concordant results across all specimen types for each individual. Specificity, which is the percentage of tests that correctly show a negative result when an individual is not infected, was 99.8% in all specimen types. Three individuals in this group were newly identified as having been infected with HCV. In testing of 92 individuals known to be infected with HCV, pre-clinical results indicated sensitivity in venous whole blood and oral fluid of 100%. In addition, 639 archived HCV-positive plasma samples were tested and similarly resulted in 100% sensitivity. Sensitivity is a measure of the percentage of tests that correctly show a positive result when an individual is infected with HCV.
The pre-clinical studies also evaluated the test's sensitivity during seroconversion. Seroconversion refers to the period of time immediately after infection during which an individual's body generates detectable antibodies to HCV. Out of 22 seroconversion panels tested, the prototype HCV test detected HCV antibody on average three days earlier than a laboratory-based assay and in no case did the prototype test detect HCV antibody later than the laboratory assay.
Hepatitis C is the most common blood-borne infection in America, affecting approximately four million people or about one in every 50 adults, according to the Centers for Disease Control and Prevention. Most people who contract the disease will develop chronic hepatitis C infection and more than half of infected persons are not aware that they have the disease. Chronic Hepatitis C can cause cirrhosis, liver failure and liver cancer. About half of all cases of primary liver cancer in the developed world are caused by Hepatitis C, and Hepatitis C related liver disease is now the leading cause for liver transplants. Without increased therapeutic treatment, the number of deaths from HCV infection is expected to increase substantially over the next 10 to 20 years due to the progression of liver disease in the infected population.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities. For more information on the Company, please go to www.orasure.com.
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