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High-Risk HPV DNA test approved by FDA.(Diogene Corp.)
2003 MAY 1 - (NewsRx.com & NewsRx.net) -- Digene Corporation (DIGE) announced that the U.S. Food and Drug Administration (FDA) has approved Digene's Pre-Market Approval Supplement (PMAS) application for its hc2 High-Risk (HR) HPV DNA Test for use with a Pap test to adjunctively screen women age 30 and older to assess the presence or absence of high risk HPV types.
The FDA's decision allows Digene to market its HPV Test with the Pap test for this screening indication.
Evan Jones, Digene's chairman and CEO, stated, "This decision represents a major advancement in the fight against cervical cancer, offering women and their physicians the first objective screening measure of a woman's risk for cervical cancer. We are extremely excited by the FDA's decision. With our hc2 HR HPV Test, when used in conjunction with the Pap test, doctors can detect cervical disease and its precursors earlier than ever before."
Jones continued, "This is a monumental achievement for Digene, underscoring our leadership in the field of cervical cancer detection and prevention, and expanding our potential U.S. target market from approximately 3 million annual tests to approximately 30-35 million annual tests. The sensitivity and negative predictive value of our hc2 HR HPV Test should improve the quality of cervical cancer screening in the United States and around the world.
"Building on the momentum generated by the new guidelines published by the American Cancer Society (ACS) in November 2002 - which recommend consideration of the combination of HPV DNA testing for high risk HPV types, together with a Pap test, as a primary cervical cancer screen following FDA approval - we look forward to an initial launch of the new indication for the High-Risk HPV DNA Test in the U.S. this spring and a full scale launch in the third calendar quarter of ...
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Source: HighBeam Research, High-Risk HPV DNA test approved by FDA.(Diogene Corp.)