Managed Care Law Weekly
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Cytyc Corp.
U.S. FDA okays expanded ThinPrep Pap Test for detecting glandular lesions
October 9th, 2005
Cytyc Corp. (CYTC) announced that the U.S. Food & Drug Administration (FDA) has approved a premarket approval supplement for the ThinPrep Pap Test related to the detection of endocervical and endometrial glandular lesions. The enhanced labeling cites multiple peer-reviewed publications that report on the improved ability of the ThinPrep System to detect glandular disease versus the conventional Pap smear. The labeling further states that the results of these studies are consistent in showing more frequent biopsy confirmation of abnormal glandular findings by ThinPrep technology compared to conventional cytology. Thus, the finding of a glandular...
Source: Managed Care Law Weekly (2005-10-09)
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