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High–risk human
papillomavirus (HPV) is now recognized as the primary causal factor in the
development of cervical cancer; studies show that high–risk HPV types
were found in greater than 99.7% of cervical cancer cases. The Digene®
HPV Test*, using Hybrid Capture® 2 (hc2) technology, is the only
FDA–approved HPV DNA test and collectively detects the 13
clinically–relevant high–risk HPV types.
Also known to laboratories as the hc2 High–Risk HPV DNA
Test® or as the DNAwithPap® Test, The Digene HPV
Test is a signal–amplified, nucleic acid test that provides standardized,
objective results upon which healthcare providers may rely on to accurately
assess patient risk for cervical intraepithelial neoplasia (CIN) and cancer.
The test has a sensitivity optimized to detect clinically relevant HPV DNA
levels and its performance has been clinically validated in studies reported in
more than 300 peer-reviewed publications based on studies involving more than
40,000 women. The Digene HPV Test is the only FDA–approved HPV test for:
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Primary screening, in conjunction with a Pap, of women age 30 years and older; and
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Triage of women of any age with ASC–US Pap results.
National guidelines and recommendations from the American College of Obstetricians and Gynecologists (ACOG), the American Cancer Society (ACS), the Association of Reproductive Health Professionals (ARHP) and the American Society for Colposcopy and Cervical Pathology (ASCCP) all now recommend that high-risk HPV testing be used in conjunction with the Pap for improved detection of cervical disease and cancer.
| HPV testing along with a Pap is emerging as a standard of care
and is acknowledged in clinical guidelines developed by major medical groups.
For laboratories, this creates the potential need to perform millions of
high–risk HPV tests annually. The real benefit for labs, clinicians, and
patients is clear: The Digene HPV Test provides greater assurance that
high–grade cervical disease and cancer are not missed and allows
clinicians to more accurately assess a woman's risk for disease based on her
HPV and Pap status. |
The Digene HPV Test offers the laboratory optimum clinical
sensitivity for patient risk assessment:
- Studies have shown the clinical sensitivity of The Digene HPV Test to be
greater than 96% for the detection of high–grade CIN and cancer when
performed with cytology, versus 84.4% for liquid cytology alone and 57.7% for
the conventional Pap alone.1
- This high sensitivity, combined with a
very high negative predictive value, means that providers can report negative
test results with confidence that CIN 2/3 and cancer are not present and that
the patient is not at risk for developing cervical cancer within the next
several years.2,3
- False–negative results have historically
reduced the effectiveness of cervical cancer screening programs because cancers
were not detected early enough, which can potentially lead to otherwise
preventable invasive treatments (such as hysterectomy) or cervical cancer death
and the associated risk for the physician of medical malpractice litigation.
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