Gynecologic pathologists Dr. Mark Stoler and Dr. Thomas Wright, both reference pathologists in the ATHENA trial, were kind enough to provide me with their thoughts regarding issues that have been raised on this site surrounding the ATHENA trial.
First, a little background. As many already know, the ATHENA trial was a multi-center, prospective study that was conducted to evaluate the Roche cobas HPV test as a potential primary screening test for cervical cancer as well as some other possible uses. It consisted of a baseline phase and a three year follow-up phase.
Based upon the results of the trial, Roche filed an application with the Food and Drug Administration (FDA) seeking approval of its cobas HPV test as a primary screening test for cervical cancer.
An advisory panel for the FDA unanimously approved the Roche cobas HPV test for that purpose early last month, which I wrote about the following week.
That post, which generated a lot of discussion, included letters two pathologists wrote to the FDA stating their opposition to isolated HPV testing in general and the cobas HPV test in particular.