Q: How have you performed cervical cancer screening in the past?
A: I've been in practice for 40 years and I have performed traditional Pap tests along with HPV tests that are able to identify some of the genotypes of HPV. My practice was involved in the ATHENA trial, which was the first screening trial for registration that evaluated simultaneous real-time genotyping of 12 pooled high-risk HPV genotypes plus HPV 16 and 18 individually. So we've had the opportunity to see firsthand how the cobas® HPV Test can benefit patients.
Q: How has the cobas® HPV Test changed the way you care for patients?
A: In the past, using a Pap test alone gave us some information but it was unable to actually delineate anything about a patient's HPV risk. Then the first type of HPV test available gave us the opportunity to see if HPV DNA was present. But this test wasn't able to identify the individual genotypes, HPV 16 and 18, that indicate the highest risk for the precursor to cervical cancer. Now, with the cobas® HPV Test, I have more clear and precise information to assess a patient's risk and a better idea of how to further evaluate or treat her.
Q: What is the value of knowing more about a patient's cervical cancer risk?
A: Ultimately, the value is always for the patient. Having the cobas® HPV Test available gives me the opportunity to define whether or not a patient is positive for any of the high-risk HPV genotypes. Specifically, knowing if a patient is positive for HPV 16 and 18, the highest risk types, helps me stratify a patient's risk. This means that we are able to identify a patient's risk early and identify the precursor to cervical cancer before it becomes a devastating disease.
Q: The cobas® HPV Test was validated in a clinical trial involving more than 47,000 women; what does that mean to you?
A: The sheer number of participants in the ATHENA trial is astonishing, and having the data and proven clinical performance of the cobas® HPV Test from a large-scale trial like ATHENA establishes the credibility of the test. In addition, the trial really showed us the medical benefits of being able to test for the 14 high-risk HPV genotypes and specifically call out individual results from HPV 16 and 18. This heightened our awareness of the potential for missed diagnoses from Pap cytology alone. One in ten women in the study, age 30 or over, who had a normal Pap but tested positive for HPV genotype 16 or 18 had cervical pre-cancer. So both the cobas® HPV Test and the ATHENA trial data have had a major impact on our practice and our care for patients.
Q: How does having a greater ability to stratify your patient's risk by knowing her HPV 16 or 18 genotype status benefit you and your patient?
A: With the cobas® HPV Test, we have the potential to prevent cervical cancer. Before we were able to get these types of results, the virus often stayed hidden until it had progressed too far. Now that we can identify a patient's risk early, we have the chance to prevent her developing cervical cancer at all. We can evaluate whether or not the cause of cervical cancer is already present before the cells change.
Q: What concerns would you have about accepting HPV test results that have not been clinically validated in a large scale trial such as ATHENA?
A: Introducing HPV co-testing to all women age 30-65, which the new guidelines recommend, is a major clinical decision. So my primary concern would be the lack of robust scientific data to validate the sensitivity and specificity of the test, and establish the clinical relevance. That's what the ATHENA trial did for the cobas® HPV Test. As the largest U.S. registration trial for cervical cancer screening, it not only demonstrated the critical role that high-risk HPV genotypes, especially HPV 16 and 18, play in cervical cancer risk assessment, but also clearly established the clinical relevance of the results of this test.
Q: Can you provide an example of how cobas® HPV Test results have influenced your treatment decisions?
A: The cobas® HPV Test has proven to be a lifesaver in my practice. We've seen a number of patients that had not tested positive for HPV in the past but were advised to have a random cervical biopsy because of abnormal Pap results to evaluate the tissue further. After performing the cobas® HPV Test on one of these patients, it came back positive for HPV 16 and we were able evaluate her further before the disease had progressed. In the past, without being able to identify the high-risk genotypes, we might miss these diagnoses and not see that patient for another year.
Dr. Surowitz was compensated for his testimonial. The information presented in this interview represents the opinion and medical decisions of the individual healthcare practitioner and is not intended to be a treatment recommendation by Roche Diagnostics.
Health Awareness Inc. Jupiter, FL