Diagnostics

U.S. FDA okays expanded ThinPrep Pap Test for detecting glandular lesions

Published in Women's Health Weekly, October 6th, 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...

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Source: Women's Health Weekly (2005-10-06)

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