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Combining Two FDA-Approved Diagnostic Tests Increased Detection of High-Grade Cervicovaginal Lesions

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Key Points

  • In a retroactive study of more than 1,600 cases with Pap and hrHPV cotesting, each test missed approximately 9% of cancer and/or high-grade lesion cases.
  • Combining the tests resulted in only 1% of cases missed.

Cytopathology researchers at Houston Methodist Hospital recently found that combining two diagnostic tests—the Papanicolau (Pap) and high-risk human papillomavirus (hrHPV)—dramatically decreased the chance of missing tumors and high-grade lesions by sevenfold.

Zhou et al published their retroactive study of more than 1,600 cases with Pap and hrHPV cotesting in Cancer Cytopathology. They found that each test missed approximately 9% of cancer and/or high-grade lesion cases. Combining the tests resulted in only 1% of cases missed.

“We’ve known that neither test is perfect and misses a certain number of cases, but we didn’t realize until we analyzed the data just how impactful the combination of these tests would be,” said Dina Mody, MD, Director of Cytopathology at Houston Methodist Hospital. “The numbers tell me that [obstetricians and gyencologists] need to regularly offer cotesting, and woman aged 30 or older need to proactively request cotesting.”

In 2014, the U.S. Food and Drug Administration (FDA) approved the use of an HPV DNA test as a primary screening tool for women 25 and older. The test detects two of the most common high-risk HPV strains (16 and 18) as well as combined results for 12 additional high-risk HPV types. However, the test only detects a small percentage of the 150 HPV strains that exist.

Study Details

Dr. Mody and her team reviewed data from 1,652 cases over an 18-month period.

Lead author Yimin Ge, MD, a member of the Department of Pathology and Genomic Medicine at Houston Methodist Hospital, compiled cases with cytology-HPV cotesting and follow-up biopsies. The researchers found that 253 cases had biopsy-confirmed high-grade lesions. Of those cases, the Pap test and the hrHPV test accurately detected approximately 91% of the cases. When they combined the tests, the team found only three of the 253 cases were double-negatives for both the Pap and hrHPV tests.

“We used a large population-based observational study, which is only the second of its kind conducted since the FDA approved the HPV test as a primary screening method for cervical cancer,” Dr. Ge said. “The next step is to look at cases missed on Pap and HPV, test the tissue, and try to determine why they were missed.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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