Roche HPV assay
This article was originally published in The Gray Sheet
Executive Summary
FDA initiates dialogue with company over classification of HPV assay as analyte-specific reagent, according to Roche, which said it plans to meet with agency officials within days. In November, FDA informed the firm that the AmpliChip microarray requires clearance prior to marketing and cannot be offered to labs as an ASR for determining drug metabolization rates. Roche has removed all information pertaining to the HPV test from its website, including a release citing claims by Jane Gibson, PhD, that the product could be more sensitive than hybrid capture technology currently on the market (1"The Gray Sheet" March 1, 2004, In Brief)...