ThinPrep labeling expanded to glandular lesions detection
The Food and Drug Administration has approved an expansion of the labeling for ThinPrep Pap Test to include detection of endocervical and endometrial glandular lesions. The new labeling cites many peer-reviewed publications as demonstrating the test's biopsy-confirmed ability to better detect abnormal glandular findings compared to the conventional Pap smear. This means, according to Cytyc Corporation (Marlborough, Mass.), that a finding of a glandular abnormality on a ThinPrep Pap Test slide merits increased attention for definitive evaluation of potential endocervical or endometrial pathology. ThinPrep is the only cervical cancer screening technology to gain expanded labeling claims related to the detection of glandular abnormalities. Currently the most widely used method for cervical cancer screening in the United States, ThinPrep is also the only method approved by the FDA as "significantly more effective than the conventional Pap smear for the detection of low-grade squamous intraepithelial (LSIL) and more severe lesions in a variety of patient populations." In addition, the test is the only liquid-based cytology that's FDA approved for HPV testing and the only FDA-approved cytology system for chlamydia testing directly from the ThinPrep collection vial.
For more information, visit the company's Web site at http:// http://www.thinprep.com/.
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