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Primary adjunctive screening with a Pap test for women age 30 and older

Reflex hc2 HPV testing

By combining The Digene^® HPV Test* (DNAwithPap^® Test) cytology, studies have shown that the sensitivity for high–grade cervical disease and cancer can now be as high as 100%¹

The Digene^® HPV Test provides clinicians and their patients greater reassurance that cervical disease and cancer won't be missed.

Research shows that 1 in 5 women who are persistently HPV positive using The Digene^® HPV Test develop CIN 2/3 within 3 years²

By using The Digene^® HPV Test as a primary adjunctive screening tool for women aged 30 and older, you are able to:

Improve the sensitivity for high–grade cervical disease and cancer (versus a Pap alone); and
Identify women who are at greatest risk for cervical disease or cancer.

Using The Digene^® HPV Test with a Pap, clinicians are able to identify more women who currently have high-grade disease or cancer, or who may be at risk in the future.

The Digene^® HPV Test Feature	The Digene^® HPV Test Benefit
The only FDA–approved HPV test.	Ensures clinicians that they are screening their patients with the most thoroughly validated HPV test. Complies with ACS and ACOG cervical cytology screening guidelines.
Clinical sensitivity up to 100% in primary adjunctive screening with a Pap.	Provides the most assurance that cervical disease and cancer are not missed.
Tests collectively for the 13 clinically-significant high–risk HPV types (16,18,31,33,35,39,45,51,52,56,58,59,68).	Detects the HPV types necessary for the development of cervical cancer.
Standardized, objective results.	Unbiased, consistent assessment of a woman's risk for developing cervical disease or cancer.

A positive high–risk HPV test result does not mean that high–grade disease or cancer is definitely present. This important information allows clinicians to identify “at–risk” patients and manage them appropriately and proactively.

¹ Clavel C, Masure M, Bory J–P, et al. Human papillomavirus testing in primary screening for the detection of high–grade cervical lesions: a study of 7932 women. Brit J Cancer, 2001; 89 (12): 1616–1623.
² Lorincz A, Richart R. Human Papillomavirus DNA Testing As An Adjunct To Cytology In Cervical Screening Programs. Arch Pathol Lab Med. 2003;127:959–968.

* "The Digene HPV Test" was approved by the US FDA and is also known to laboratories and physicians as the "hc2 High–Risk HPV DNA Test^®" and "DNAwithPap^® Test." This does not refer to the Digene product that tests for several types of the virus commonly referred to as "low–risk HPV," which are not associated with cervical cancer.