More Effective
The ThinPrep® Pap Test is significantly more effective than the conventional Pap smear for the detection of low-grade and more severe squamous intraepithelial lesions in a variety of patient populations. The ThinPrep Pap Test improved the detection of precancerous lesions by 65% in screening populations and 6% in high-risk populations when compared with the conventional Pap smear. Cervical cancer is one of the most common cancers among women but if detected early is almost always curable. Early detection of cervical disease usually means less traumatic intervention and can be expected to improve quality of life, increase life expectancy and reduce overall health care costs.

Improved Specimen Quality
The ThinPrep method also improves specimen quality by reducing blood, mucous, inflammation and other obscuring artifacts.

The Conventional Pap Smear vs. The ThinPrep® Pap Test Slide

With the conventional Pap smear method, cells can be obscured by blood, mucus, and inflammation

The ThinPrep Pap Test method preserves the cells and minimizes cell overlap, blood, mucus, and inflammation.

Additional Diagnostic Testing
The ThinPrep Pap Test does not consume the entire fluid-based sample collected in the specimen vial. Additional diagnostic testing of the residual sample can increase the information yielded by the ThinPrep Pap Test. The greatest opportunity is in human papilloma virus (HPV) typing of samples that show possible, but inconclusive morphologic abnormality. The FDA recently approved HPV testing directly from the PreservCyt vial used for the ThinPrep Pap Test. The National Cancer Institute estimates that about 3.5 million Pap smears are found to be inconclusive each year in the US which often lead to unnecessary colposcopy, biopsy and office visits. The average cost of the standard management of such cases is about $1,200 per case. The NCI estimates the cost to the US health care system at about $3.6 bil. each year. HPV typing of samples diagnosed as ASCUS (atypical squamous cells of undetermined significance), or low-grade squamous intraepithelial lesion may help triage women into conservative follow-up, or colposcopy and biopsy. Such a study is underway by the National Cancer Institute's ALTS trial, which utilizes the ThinPrep Pap Test in conjunctions with HPV DNA typing to assess triage strategies. By using the ThinPrep Pap Test, this determination, that can be performed without a repeat patient examination, may lead to substantial cost savings and more appropriate patient management.

Economic Advantages
Cervical cancer is a disease that progresses through pre-cancerous and cancerous stages over a number of years. More important, cervical cancer is virtually 100% curable if it is detected and treated appropriately in the earlier stages of progression. Conversely, the cost of treatment increases significantly if cervical disease is discovered at later stages.

Summary of Advantages
The increased rate of detection of disease demonstrated by the ThinPrep Pap Test provides a new level of confidence for laboratories, clinicians and patients. At the same time the significant improvement in specimen quality and the ability to do multiple testing using the same sample, will substantially reduce costs and patient anxiety associated with re-screening and unnecessary follow-up testing.

Clinical Trials
FDA approval of the ThinPrep® Pap Test as a replacement for the conventional Pap smear and the claim the ThinPrep Pap Test is "significantly more effective" was based on extensive data submitted from a multi-site pivotal clinical trial. This study of 6747 women was conducted using a matched-pair, double-blinded protocol. The results of this study indicate that the ThinPrep Pap Test significantly increases the detection of low-grade or more severe lesions by 65% in screening populations and 6% for high risk populations when compared with the conventional Pap smear. This study also found that the ThinPrep Pap Test reduced by 29% the number of suboptimal or inadequate slides that frequently prompt the need for a repeat test. This study employed a split-sample, matched-pair protocol in which the conventional smear was made first and then only the residual material was rinsed in to the ThinPrep PreservCyt® vial, therefore, favoring the conventional smear preparation. Further direct-to-vial studies found that when the cervical sampling device is rinsed directly into the vial as it is intended in routine use, the number of suboptimal or inadequate slides could be reduced by greater than 50%. In addition, a study supporting our PMA (Pre-Market Approval) supplement to allow use of the combination endocervical brush and spatula sampling method shows a 110% increase in detection of LSIL and higher diagnoses.