American Society for Clinical Pathology

Following HPV DNA Testing Guidelines Lowers Healthcare Costs, Prevents Overtreatment

American Journal for Clinical Pathology highlights HPV Test Utilization Policies

CHICAGO – June 11, 2009 – Excessive testing for the human papillomavirus (HPV) may result in over-management and harmful treatment for benign conditions while minimally reducing cancer incidence, according to a recent article in the June 2009 issue of American Journal of Clinical Pathology (AJCP).

In the article, health experts from top medical institutions, including the National Institutes of Health (NIH), agree that HPV testing is a powerful adjunct to Pap tests, but that the benefit is only realized when 1) clinicians understand when the HPV test is best used and 2) when the patient safety is kept in the forefront. Overtesting and testing women who are at virtually no risk of cancer adds cost without benefit.

Developed by the Cytopathology Education and Technology Consortium, and endorsed by ASCP, the American Cancer Society, and several other professional medical societies, the Statement on HPV DNA Test Utilization delineates the appropriate and inappropriate uses of HPV.

“Too many young women are undergoing additional treatment that has a likelihood of being unnecessary,” said ASCP President Barbara J. McKenna, MD, FASCP, who is also associate professor of pathology at the University of Michigan Medical School. “While there are always unique cases, the guidelines outlined by the Cytopathology Education and Technology Consortium give guidance that protects patients and prevents a cost drain to the healthcare system.”

When is HPV testing useful and appropriate?
HPV testing should be used only for high-risk HPV types: The test should be FDA-approved or clinically validated with the supporting data subject to peer review. Testing for low-risk HPV serves no clinical purpose and cannot be justified. HPV testing is clinically indicated for the triage of patients with equivocal cytology results (atypical squamous cells). In addition, co-testing with the Pap test in women over 30 years of age provides predictive safety for at least three years in women who are negative on both tests. Therefore, women who choose this form of combined testing should not be screened more frequently.

When is HPV testing inappropriate?
HPV testing should not be done in women younger than 30 in routine cervical cancer screening. It also should not be done more frequently than every three years as a screening test in women over 30. Also, it should not be the automatic follow-up test or “reflex” to abnormal test results in adolescents (women younger than 20). If HPV testing is inadvertently administered to adolescents, the results should not be used to influence patient management.

The AJCP article states that HPV is common, but cervical cancer is not. Some types of HPV are associated with precancer and cancer and are considered high risk, whereas others are considered low risk. According to the U.S. Centers for Disease Control and Prevention, at least half of sexually active people will have HPV in their lives, but few will get cancer.

“Beyond the cost issues that arise out of unnecessary testing, another point to consider is the physical discomfort and anxiety that a woman suffers in anticipation of an often unnecessary, invasive procedure,” added ASCP President-Elect Mark Stoler, MD, FASCP. “The main point of these published statements is to remind physicians that they and their patients should take full advantage of the new HPV molecular technology, and that they should use the right test or tests at the correct intervals so as to reap the benefits of improved sensitivity, but not the downsides of excessive testing. More is not always better.”

Dr. Stoler is Professor of Pathology, Cytology & Gynecology, University of Virginia Health System, Charlottesville, and has long been involved in research that led to the development of both HPV testing and the HPV vaccine. To read “Statement on HPV DNA Test Utilization” and the commentary please click here.

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