Why choose the ThinPrep Pap Test?

In the United States, both the ThinPrep Pap Test and SurePath™ are approved liquid-based pap tests. While each has demonstrated the ability to improve specimen adequacy compared to a conventional pap smear, only one — the ThinPrep Pap Test — has been FDA-approved as "significantly more effective".

Unlike other liquid-based technologies, the ThinPrep Pap Test has acquired additional FDA approval for ancillary use with other tests. Ancillary testing from the ThinPrep Pap Test vial requires that the product be safe and effective as shown through valid scientific evidence. This evidence has demonstrated consistent and reproducible performance with these ancillary tests that can be consistently fulfilled in various laboratory settings. To date, only the ThinPrep Pap Test has been approved for these ancillary tests.

The ThinPrep Pap Test vs. SurePath™

	ThinPrep	SurePath™
Year Approved	1996	1999
Compared to Conventional Pap	Significantly more effective	Similar to conventional
Improved Specimen Adequacy	Yes	Yes
Improved HSIL Detection vs. Conventional Pap	Yes	Yes
Glandular Disease Detection	Yes*	No
Approved for Adjunctive HPV Testing	Yes	No
Approved for Adjunctive Chlamydia and Gonorrhea Testing	Yes	No

*The ThinPrep Pap Test is the only pap test for which the FDA has approved labeling, supported by multiple peer-reviewed publications report improved glandular disease detection.^1-6

Far more than a productivity tool:
the ThinPrep Imaging System with Dual Review

The ThinPrep Imaging System for use with the ThinPrep Pap Test, and the FocalPoint™ Slide Profiler that works with SurePath™ and conventional pap smears are computer-aided screening tools approved for use in the United States. Although both work on the principle of morphometry, and both can be used with liquid-based pap slides, there are some key differences between these two systems:

• The FocalPoint slide processor determines the probability of disease within a population of slides using an algorithm to classify the slides in the batch as No Further Review, Review, or QC Review. The FocalPoint system allows for up to 25% of slides to be archived and never reviewed by a human, and cells in question are not marked to direct the laboratory professional to the points where attention is needed the most.⁹
• In comparison, the ThinPrep Imaging System evaluates each patient slide, prioritizing areas of interest based on the DNA content of individual cells and cell clusters. Therefore, when a cytotechnologist and cytopathologist review such slides, the areas of special interest are clearly marked. Moreover, every slide is reviewed by a human after the slide is "imaged" to ensure that these areas of interest are evaluated by a highly skilled professional. This Dual Review has led to increased sensitivity and specificity as well as a reduction in the false negative fraction over manually reviewed slides.⁷

The ThinPrep Imaging System is quickly becoming the standard of care in cervical cytology. Today, 60% of ThinPrep Pap Tests are imaged with the ThinPrep Imaging System⁸ — increasing disease detection with Dual Review.

The ThinPrep Imaging System with Dual Review vs. FocalPoint slide profiler^9,10

	ThinPrep Imaging System with Dual Review	FocalPoint™ Slide Profiler
FDA-approved	2003	1999
All slides reviewed by a human	Yes	No*
Increased disease detection over liquid-based cytology alone	Yes	No9,10
Approved for high-risk patients	Yes	No

*FocalPoint labeling allows up to 25% of slides to be archived and never reviewed by a human.

Learn more about the benefits of Dual Review

Do you see high-risk patients in your practice?

One key difference between the two systems is that the ThinPrep Imaging System is approved for all patients including high-risk patients, whereas the FocalPoint system is not. "High-risk" is defined in the FocalPoint product labeling as:

• Prior abnormal gynecologic history
• Post-menopausal or abnormal vaginal bleeding
• DES patients
• Previous breast cancer or history of malignancy
• Previous tissue or pap diagnosis of HPV, dysplasia, or HIV infection
• Multiple sex partners
• Visible lesion
• Early age of sexual intercourse
• Smoker

Why nearly 90% of physicians choose the ThinPrep Pap Test

When compared to other liquid-based technologies, the ThinPrep difference is clear:

• Greater disease detection — even over manually screened liquid-based tests
• FDA-approved ancillary testing from the ThinPrep Pap Test vial
• Approved for all patient types

Next: FDA-approved