The ThinPrep Pap Test is the only replacement to the conventional Pap test that has FDA labeling claims stating that the product is 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. Additionally, data from a multi-site clinical outcome trial, in which ThinPrep specimens were collected prospectively and compared against an historical control cohort, indicated a 59.7 percent increase in the detection of high-grade squamous intraepithelial (HSIL) and more severe lesions.

Why you should be using the ThinPrep® Pap Test
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Since its introduction over fifty years ago, the cervico-vaginal Papanicolaou (Pap) smear has been a powerful tool for detecting cancerous and precancerous cervical lesions. During that time, the Pap smear has been credited with reducing mortality from cervical cancer by as much as 70%.1, 2 This once precipitous drop in the death rate has slowed however, and the mortality rate in the USA for this preventable disease has remained virtually constant, at about 5,000 per year since the mid-eighties.3 Therefore, about one-third of the 15,000 women diagnosed with cervical cancer annually still die because the cancer was detected too late. A further cause for concern is National Cancer Institute data that shows an annual 3% increase in the incidence of invasive cervical cancer in white women under 50 years of age since 1986. 4

A number of factors may be contributing to this current threshold, not the least of which is the fact that many women, particularly in high risk populations, are still not participating in routine cervical cancer screening. Another contributing factor that has received much attention is the limitation of the traditional Pap smear method itself.5,6

The reliability and efficacy of a cervical screening method is measured by its ability to diagnose precancerous lesions (sensitivity) while at the same time avoiding false positive diagnosis (specificity). In turn, these criteria are dependent on the accuracy of the cytological interpretation. The conventional Pap smear has false negative rates ranging from 10-50% and up to 90% of those false negatives are due to limitations of sampling or slide preparation.7-10 It has been shown that only a small portion of the sample taken from the patient is transferred to the slide; most of it is discarded along with the sampling device.11-13 Accurate interpretation of up to 40% of conventional Pap smears are compromised by the presence of blood, mucous, obscuring inflammation, scant cellular material and air-drying artifact.14

In order to address these problems, Cytyc Corporation has developed the ThinPrep Pap Test. In May 1996, the Food and Drug Administration (FDA) approved the ThinPrep 2000 as a replacement for the conventional Pap smear method for use in screening for the presence of atypical cells, cervical cancer or its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions), as well as all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnosis.15

On November 6, 1996, the FDA approved revised labeling allowing Cytyc to claim that:

The ThinPrep 2000 System is 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.

Specimen quality with the ThinPrep 2000 System is significantly improved over that of conventional Pap smear preparation in a variety of patient populations.