Digene DNA Pap Test Cost-Benefit Studies Set Stage For Reimbursement
This article was originally published in The Gray Sheet
Recent studies evaluating the cost-effectiveness of Digene's DNA Pap test for cervical cancer may help support reimbursement for a primary screening indication pending FDA approval, the firm says
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Digene will re-analyze pivotal study data to demonstrate clinical utility of its HPV DNA Pap test as a primary screen for cervical cancer in response to an FDA request for additional information
The payback on Cytyc's $554 mil. acquisition of Digene could get a quick boost from Digene's pending primary screening indication for DNA Pap for cervical cancer
Digene will reanalyze clinical data and specimens from a 23,702-patient trial in Portland, Oregon, prior to seeking a primary screening indication for its HybridCapture 2 HPV test. The Gaithersburg, Maryland firm expects to file a PMA supplement by year-end.