LINCOLNSHIRE, ILLINOIS--(Marketwire - July 21, 2008) - MonoGen, Inc. (TSX: MOG)(the “Corporation”) today announced that it has received U.S. Food & Drug Administration (FDA) approval to expand its labeling for the MonoPrep® Pap Test to include data and conclusions from its SURE (Specimen UNSAT Rate Evaluation) post-market approval study. The SURE study demonstrated a statistically significant reduced number of MonoPrep Pap Test slides that were Unsatisfactory for review (UNSAT) compared to conventional Pap smear slides from the same patients. Due to the fact that a diagnosis cannot be rendered from an UNSAT slide, the patient must return to the clinician at a later time for a repeat Pap test. This additional test is an inconvenience for the patient and is costly for the laboratory and clinician.
