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    cobas® HPV Test

    Risk matters. Deliver 3 results in 1 test for accuracy that your clinical partners expect and that patients deserve      

"Getting 3 results in 1 HPV test has changed the way I treat patients with atypical Pap results."


Q: How have you performed cervical cancer screenings in the past?

A: In my 20 years of practice, times have changed significantly in regard to cervical cancer screening. We've gone from annual Pap tests for every woman, regardless of age, in the ’90s, to being able to co-test and check for the 14 high-risk HPV types. With the development of more advanced diagnostic tools, we've been able to learn a lot about HPV 16 and HPV 18, the most oncogenic strains of HPV. Now we can better identify, counsel and manage the patients who are at the highest risk for having dysplasia.

Q: How has the cobas® HPV Test changed the way you care for patients?

A: Around spring of 2011, my colleagues and I learned about Roche's landmark ATHENA Trial utilizing the cobas® HPV Test. This was the first screening trial for registration that evaluated simultaneous real-time genotyping of 12 pooled high-risk HPV genotypes plus individual genotyping for HPV 16 and HPV 18, the highest-risk types. Before we had these individual results, the biggest problem we had with ASC-US* patients was determining what follow-up steps to take when an HPV test result indicated that a patient was at risk but the colposcopy showed no lesions. It was confusing for the patients and frustrating for the clinicians. With thecobas® HPV Test, we know if a patient is HPV 16 or 18 positive, and that means I may take a different approach in how I further examine her—such as following up with biopsy—how I counsel her, and how I work with my staff to follow up with her.

Q: What is the value of knowing more about a patient's cervical cancer risk?

A: In the case of patients with an ASC-US Pap test, having access to the individual HPV 16 and 18 results with the cobas® HPV Test has allowed us to identify patients who are at the highest risk of developing dysplasia, and patients have a better understanding of why we need to do further and, frankly, more-invasive testing. If we're working with a patient who is 16 or 18 positive, suddenly there is a much greater probability of having either cervical dysplasia or cancer. This helps me, as a clinician, to create a different plan of action for follow-up and for managing the patient—and it makes it easier to explain to the patient what we need to do next and why we are doing it.

Q: What is the value of receiving three results in one test for ASC-US triage patient management?

A: Having individual results on HPV 16 and 18, the highest-risk genotypes, along with a pooled high-risk result, gives me a much greater ability to tell a patient her actual risk of having cervical precancer. This has brought about a major change in our treatment of patients with an ASC-US Pap test. Now that we're able to assign or stratify a risk based on HPV 16 and HPV 18 positivity, it's empowering me be more diligent and more aggressive in my examination and follow-up.

Q: How does knowledge of HPV 16 and 18 statuses change the way you may manage ASC-US patients?

A: A patient with an ASC-US Pap and a positive HPV 16 status could have a 1 in 3 chance of a high-grade cervical dysplasia or malignancy. This information makes me much more vigilant during colposcopy. I am more likely to biopsy a region of questionable abnormality, or to strongly consider a random biopsy.

Q: Can you describe an experience counseling a patient based on a Pap test and a pooled HPV test result when the additional knowledge of her 16/18 genotype status would have changed the discussion and the patient management?

A: Last year, I was performing an annual examination on a patient who had been coming to my practice for about a year. I performed a Pap test along with the cobas® HPV Test. Her Pap came back as ASC-US and the cobas® HPV Test results showed an HPV 16 positive status. We performed a colposcopy and, initially, we didn't see too much. But because I knew that HPV 16 positive status, I did a biopsy along with an additional random biopsy of a separate area of the cervix. The random biopsy came back with moderate-to-severe cervical dysplasia. At that point, after talking through her options for care, she decided to undergo a laparoscopic hysterectomy. The final pathology on the hysterectomy was severe cervical dysplasia extending, or going up into, the cervix. If I hadn't had the HPV 16 positive status and the additional biopsy, I wouldn't have found the abnormalities and I wouldn't have pursued any treatment. So knowing the HPV 16 positive result made me do a more thorough colposcopy and made the difference of me diagnosing her versus her going on to develop cervical cancer in the future. That's just one example of how having the additional information from the cobas® HPV test has helped me manage a patient more effectively.


Footnote:

Dr. Glad serves as a paid speaker with the Roche Diagnostics Clinician Speakers Bureau and was compensated for his testimonial. The information presented in this interview represents the opinions and medical decisions of the individual healthcare practitioner and is not intended to be a treatment recommendation by Roche Diagnostics.


CLINICIAN PROFILE

Lawrence J. Glad, MD, CCD, FACOG

Director of Surgery, Uniontown Hospital Uniontown, PA


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