Studies have shown that by combining the digene HPV Test* with cytology for women age 30+, the sensitivity of cervical cancer screening for high-grade disease and cancer can now be as high as 100 percent.1
The digene HPV Test provides clinicians and their patients greater reassurance that cervical disease and cancer won't be missed.
Research shows that one in five women who are persistently HPV-positive using the digene HPV Test develop CIN 2/3 within three years2.
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, ACOG and ASCCP cervical cytology screening guidelines.
|
| Clinical sensitivity up to 100% for primary adjunctive screening with a Pap. |
- Provides maximum assurance that cervical disease and cancer are not missed.
|
| Tests collectively for the 13 clinically most-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. |
- Provides an 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 present. Rather, this 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 U.S. 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 QIAGENE product that tests for several types of the virus commonly referred to as "low-risk HPV," which are not associated with cervical cancer.
