ThinPrep labeling enhanced
This article was originally published in The Gray Sheet
Executive Summary
FDA clears liquid-based Pap test for the detection of glandular lesions, Cytyc announces Sept. 8. Glandular lesions are linked to the only endocervical form of cancer that is increasing in the U.S., particularly among women under 35, according to company statistics. ThinPrep's approved labeling cites multiple peer-reviewed publications indicating the superior sensitivity and specificity of the test in diagnosing glandular disease versus the conventional Pap smear. ThinPrep is now the only cervical cancer technology to carry this label, Cytyc says...