Chromogenix, One-Stage Clotting Assays OK With Genetics Institute ReFacto
This article was originally published in The Gray Sheet
Executive Summary
Clinicians may use either a one-stage clotting assay or a chromogenic substrate assay with Genetics Institute's ReFacto provided that the dose of the recombinant Factor VIII product is adjusted to reflect the lower results obtained with the former, FDA's Blood Products Advisory Committee agreed at its Dec. 11 meeting.