FDA approves ThinPrep Pap test claim
This article was originally published in Clinica
Executive Summary
The US FDA has approved Cytyc's claim that the ThinPrep Pap test is significantly more effective than the conventional smear method. It is the first time the agency has allowed a company to make such a claim on a Pap screening technique. Clinical trials demonstrated that the test improved the detection of low-grade and more severe lesions by 65% and reduced the number of less than adequate specimens by more than 50%.