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HPV Medical Guidelines
HPV testing along with a Pap is emerging as the standard of care and is acknowledged in clinical guidelines developed by major medical groups including 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).
Evolution of The Digene® HPV Test and HPV Testing Medical Guidelines |
| 2005 |
In September 2005, ACOG issued a Practice Bulletin entitled, "Management of Abnormal Cervical Cytology and Histology." In addition to providing a background on cytologic and histologic findings and interpretation, the document outlines how HPV DNA testing can be used to help manage patients with varying levels of cervical abnormalities.
An ACOG Practice Bulletin on HPV issued in April 2005 reported that HPV testing is "more sensitive than cervical cytology" for detection of pre–cancerous cells and cervical cancer. It further stated that combining HPV testing with cytology has "a negative predictive value for CIN 2 and CIN 3 of 99 to 100 percent," and offered that "because HPV DNA testing is more sensitive than cervical cytology, women with negative concurrent test results can be reassured that their risk of unidentified CIN 2 and CIN 3 or cervical cancer is approximately 1 in 1,000."
Addressing the impact of test results on patient management, ACOG recognized the interim patient management guidelines published in 2004 (see below) which recommended that women older than 30 years who have high–risk HPV but negative cytology "should have both tests repeated in 6–12 months", also noting that women with persistent HPV on repeat testing "should undergo colposcopy regardless of the cytology result."
Click here for additional information on the 2005 ACOG Practice Bulletin. |
| 2004 |
Patient management guidelines published in Obstetrics and Gynecology were designed to assist clinicians in using HPV DNA testing while minimizing unnecessary evaluations and treatments. Among several recommendations, the guidelines recommended that colposcopy not be performed on women with negative cytology results and positive HPV results, because this population is at a relatively low risk of having high–grade cervical neoplasia. Instead, the guidelines recommended that HPV DNA testing and cervical cytology be repeated in these women at 6 to 12 months. Click here for additional information on the interim guidance. |
| 2003 |
The U.S. FDA approved The Digene® HPV Test (introduced as the DNAwithPap® Test) for primary adjunctive screening together with the Pap in women 30 and over.
Following FDA approval of The Digene® HPV Test* for primary screening, ACOG issued a Practice Bulletin for cervical cytology screening in July 2003. It included guidance for the combined use of a Pap test and an FDA-approved high-risk HPV test for women age 30 and older. Click here for additional information on the 2003 ACOG Practice Bulletin.
In September 2003, ARHP published a document called Clinical Proceedings: Advances in Cervical Cancer Prevention, which incorporated the ACOG recommendations for primary screening, including the use of the Pap along with high–risk HPV testing in women age 30 and older. Click here for additional information on the ARHP Clinical Proceedings. |
| 2002 |
American Cancer Society guidelines, published in November 2002, recommended that healthcare professionals consider combining the Pap test with an HPV DNA testing for high–risk HPV types, together with a Pap test, as a primary cervical cancer screen in women age 30 and older, contingent upon FDA approval. Click here for additional information on the ACS guidelines. |
| 2001 |
In 2001, the American Society for Colposcopy and Cervical Pathology (ASCCP) sponsored the first evidence–based, national practice guidelines on managing patients with abnormal Pap results. These guidelines indicated that when liquid–based cytology is used or when co–collection for HPV DNA testing is done, reflex HPV DNA testing is the preferred approach for resolving ASC–US Pap results. Click here for additional information on the ASCCP guidelines. |
| 2000 |
The FDA approved Digene's HPV Test, then known as the Hybrid Capture® 2 (hc2) High-Risk HPV DNA Test®, for triage of inconclusive/ASC-US Pap results |
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.
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