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Digene Receives FDA Approval for Gene Probe Manufacturing Facility



AITHERSBURG, Md.--Digene has received approval from the US Food and Drug Administration to manufacture and distribute products of its Hybrid Capture Gene Analysis System at the company's new manufacturing, research, and development, and headquarters here. The approval covers the Digene Hybrid Capture II HPV Test for cervical cancer screening. The new facility was designed for high volume manufacturing of the company's gene analysis tests. Digene develops, manufactures, and markets proprietary DNA and RNA testing systems for the screening, monitoring and diagnosis of human diseases. The company has developed and is commercializing its patented Hybrid Capture Gene Analysis System and tests in three areas: women's cancers and infectious diseases, blood viruses, and pharmacogenomics.

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