Monogram edges closer to HIV market:
This article was originally published in Clinica
Executive Summary
Monogram Biosciences has taken yet another step closer to marketing its HIV test for predicting response to a new type of drug being developed by Pfizer, after the pharmaceutical was issued an approvable letter by the US FDA. Its co-receptor tropism assay, Trofile, was used to select the more than 2,000 clinical trial patients worldwide who have received treatment with the drug - a CCR5-antagonist called maraviroc. Trofile will be made commercially available after the drug has received a definitive approval, which is pending the resolution of outstanding questions and the finalisation of product labelling between Pfizer and the FDA.