Panel To Review Labeling Change For Digene's Hybrid Capture CMV Test
This article was originally published in The Gray Sheet
Executive Summary
Whether Digene's Hybrid Capture cytomegalovirus DNA test technology truly incorporates signal amplification will be discussed at a May 20 meeting of FDA's Microbiology Devices Advisory Panel. Digene seeks to include this claim in its labeling for two reasons, according to the Beltsville, Maryland-based firm: higher reimbursement and competitive positioning.