This article was originally published in The Gray Sheet
Automated Pap test packaging will include data showing a 60% increase in detection of high-grade squamous intraepithelial and more severe lesions (HSIL+) with the system compared to conventional Pap smears after FDA approval of the labeling change via PMA supplement, announced Aug. 8. Multi-site clinical trial data to be included in the device's package insert show a detection rate of 511/20,917 (2.4%) for the conventional Pap smear versus 399/10,226 (3.9%) for the ThinPrep
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