The ThinPrep Difference
Overview of ThinPrep
Clinical and Independent Studies
Since the ThinPrep Pap Test was approved by the FDA in 1996, more than 170 studies have demonstrated its benefits, including increased disease detection, reduction of equivocal diagnoses, improved specimen adequacy, adjunctive molecular testing, morphology assessment, and cost effectiveness. These published, peer-reviewed studies involving hundreds of thousands of patients show a significant benefit in the ThinPrep Pap Test compared to a conventional pap smear. These studies, conducted in seven different countries over four continents, also consistently demonstrate improved specimen adequacy. Additionally, the ThinPrep Imaging System has been shown to provide further improvements in disease detection along with decreased false negative rates compared to manually reviewed ThinPrep Pap Test slides.
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Biopsy-confirmed clinical data show that the ThinPrep Imaging System provides improved disease detection over manually reviewed ThinPrep Pap Test slides.
The ThinPrep Pap Test increased detection of HSIL and more severe lesions compared to the conventional pap smear in a multi-site, historically-controlled study of routine pap testing and referral patient populations at ten leading academic institutions.
In independent studies, the ThinPrep Pap Test has been proven to provide improved disease detection vs. a conventional pap smear.
Currently, more than 40 studies evaluating the benefits of ThinPrep Pap Test technology conducted outside of the United States have been published in peer-reviewed literature.
The ThinPrep Pap Test is approved by the FDA as a platform for HPV DNA testing directly from the collection vial. A study conducted by the National Cancer Institute concluded that HPV testing is a viable method for determining which patients with borderline pap test results are at highest risk for developing cancer.
An independent study showed that combining use of the ThinPrep Pap Test with increased patient compliance would be more cost-effective at decreasing cervical cancer incidence than increasing the present rates of pap testing using a conventional pap smear.1
A comprehensive bibliography of articles published about the ThinPrep Pap Test and the ThinPrep Imaging System is provided for your reference.
1. Montz FJ, Farber FL, Bristow RE, Cornelison TE. Impact of increasing Papanicolaou test sensitivity and compliance: a modeled cost and outcomes analysis. Obstet Gynecol. 2001;97(5):781-8.