After an FDA committee approved unanimously to recommend that the Pap smear be replaced with a HPV test in March, the company behind the high-tech test has asked the Food and Drug Administration to adopt it as a first-choice screening tool to detect cervical cancer, a move that has angered many patient groups.
The cobas HPV test, made by Roche, uses DNA to detect the human papillomarvirus, or HPV--the main cause of cervical cancer. The technology has been available for years, and is frequently used along with the Pap smear by doctors. Roche wants the FDA to approve the test as the first screening tool used by doctors, which could eventually phase out the mainstay Pap smear, what advocates described as a cheaper and simpler screening tool.
In response to Roche's request, a number of women's groups -- including the American Medical Women's Association and Our Bodies Ourselves -- has sent a letter decrying the potential shift to FDA Commissioner Dr. Margaret Hamburg, which they fear would lead to overtreatment and higher costs.
Dr. Thomas Wright, M.D., Professor Emeritus of Pathology and Cell Biology at the New York Presbyterian Hospital at the Columbia University Medical Center. His current research looks at the safety and efficacy of cervical cancer screening. He is a paid consultant with Roche, which makes the test.
Diana Zuckerman, Ph.D., President of the Cancer Prevention and Treatment Fund; Epidemiologist trained at Yale University