Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Wednesday September 3 10:44 AM EDT
As a result of the expanded relationship with Murex, the two companies will be the first to provide customers in Europe with a combined test offering of HIV RNA, CMV DNA, HIV drug resistance monitoring, and traditional HIV serology tests. Registration of the HIV RNA test is expected to begin shortly, with registration time frames varying based on individual country requirements.
Based on Digene's Hybrid Capture II technology, the HIV RNA Test is designed to provide sensitive, accurate, reproducible and reliable measurements of HIV viral load. The new Digene HIV RNA test has not been approved for sale in the U.S. nor is it currently offered for sale in the U.S. Protocols for clinical trials to support a product submission to the FDA in the U.S. are currently being developed.
Digene's CMV DNA test is intended to provide clinicians with a cost effective and timely aid for diagnosing CMV infection. CMV infection causes blindness in many AIDS patients, and is a major cause of infection and death in organ transplant recipients.
Neither the Digene CMV DNA Test nor the Digene HBV DNA Test are approved in the U.S.
International Murex Technologies Corporation is a vertically integrated, medical diagnostic products company that through its subsidiaries is dedicated to the research, manufacture and marketing of products for the detection, monitoring and screening of infectious diseases and other medical conditions. The Company manufactures and markets more than 600 products on a worldwide basis. Murex has marketing and distribution activities in more than 100 countries, with direct local representatives in 35 leading markets.
Digene Corporation develops, manufactures and markets DNA testing systems for the screening, monitoring and diagnosis of human diseases. Digene's products are designed to help improve clinical outcomes and reduce the overall cost of disease management. Digene's lead product, the Hybrid Capture HPV DNA test detects the presence of HPV, the primary cause of cervical cancer, which is the second most common cancer among women worldwide. The basis for the Company's tests is its proprietary Hybrid Capture technology. Digene is using its Hybrid Capture technology as a platform to develop a wide range of DNA diagnostic and monitoring tests for blood viruses, sexually transmitted diseases and opportunistic infections.
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Consequently, actual results may vary materially from expectations. Meaningful factors which could cause actual results to differ from expectations include, but are not limited to, uncertainty of future profitability, uncertainty of market acceptance, dependence on a single product, impact of competitive products, limited sales and marketing experience with product, adequacy of third party reimbursement, extent of government regulations, and the uncertainty regarding patents and proprietary rights and technological obsolescence, as well as other factors discussed in the Company's Securities and Exchange Commission filings.
SOURCE: Digene Corporation
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