NCHR Testimony on the Evaluation for High-Risk HPV Detection Devices

Dr. Varuna Srinivasan, MBBS, MPH, National Center for Health Research, March 8th 2019

Thank you for the opportunity to speak today. My name is Dr. Varuna Srinivasan. I am a physician with a Master of Public Health from Johns Hopkins University. I am a Senior Fellow at the National Center for Health Research, which analyzes scientific and medical data to provide objective health information to patients, health professionals, and policymakers.

We do not accept funding from drug and medical device companies, so I have no conflicts of interest.

  1. We would like to start by saying that we agree with the FDA’s evaluation that a clinical endpoint of CIN3+ for a HrHPV test is more meaningful in assessing pre-cancerous lesions. We agree that although the prevalence of these lesions is seen in fewer numbers in the population, recruiting more women for evaluation studies to detect CIN3+ will help maximize resources and prevent overtreatment in the future.  For these reasons, the National Center for Health Research encourages the panel to consider the presence of CIN3+ alone as a positive result and not the combination of CIN2+/CIN3+.
  2. We disagree with the proposed indications for use. As the FDA pointed out, 90% of all HPV clears on its own.  On average, women over 30 tend to have fewer sexual partners and more monogamous relationships than women under 30, and women over 65 have even fewer. That is why the USPSTF recommends co-testing or Pap smears every 5 years for women under 30 years of age.  The FDA proposal to screen all women from 25-60 with the HrHPV test exposes a large population of women to this test unnecessarily.  For that reason, we believe that HR HPV testing should be recommended only for women over the age of 30.1

It is important to keep in mind that Pap smears directly determine the presence of cancerous or precancerous cells in your body. Co-testing can provide the added benefit of identifying high-risk HPV infection and allow for more vigilant follow-up if HPV-16 or HPV-18 is diagnosed.

We respectfully urge the panel today to consider these suggestions while providing their final recommendations.

Thank you.

1 Varuna Srinivasan, MBBS, MPH, Jared Hirschfield, National Center for Health Research. Cervical Cancer Screening Options: What Is Best For You?

The advisory committee panel deliberated and provided input on specific questions prepared by the FDA to discuss new approaches to the development and evaluation of HR HPV devices. The FDA 24 Hour summary provides information on the topics and questions discussed during this meeting and can be found here