Roche call for US approval for DNA cervical cancer test opposed

PUBLISHED : Wednesday, 16 April, 2014, 10:01pm
UPDATED : Wednesday, 16 April, 2014, 11:10pm


A hi-tech screening tool for cervical cancer is facing resistance from more than a dozen US patient groups, who warn that the genetic test could displace a simpler, cheaper and more established mainstay of women's health: the Pap smear.

The new test from Swiss drug maker Roche uses DNA to detect the human papillomavirus (HPV), which causes nearly all cases of cervical cancer.

While such technology has been available for years, Roche wants the food and drug administration (FDA) to approve its test as a first-choice option, bypassing the decades-old Pap test.

But women's groups — including the American Medical Women's Association and Our Bodies Ourselves — warn that DNA-based testing would be a "radical shift" in medical practice that could lead to confusion, higher costs and overtreatment.

"It replaces a safe and effective, well-established screening tool and regimen that has prevented cervical cancer successfully in the US with a new tool and regimen not proven to work in a large US population," state the groups in a letter to FDA commissioner Dr Margaret Hamburg. The letter is signed by 17 patient advocacy groups, including the Consumers Union, the Cancer Prevention and Treatment Fund and the National Alliance for Hispanic Health.

Chief among the advocates' concerns is that HPV-only testing could lead to overtreatment of younger women who carry the virus but have little risk of developing actual cancer. Most sexually active young people will contract HPV, though their bodies usually eliminate the virus within a few months. Only years-long infections develop into cancer.

"Unfortunately, the HPV test by itself isn't very useful because so many young women have HPV that will disappear without any treatment," said Diana Zuckerman of the Cancer Prevention and Treatment Fund. "Having an HPV test without also having a Pap smear to check for problems is going to scare a lot of women who are not developing cervical cancer."

An FDA spokeswoman said the agency could not comment on the letter since it dealt with a product under review.

For decades the Pap test was the only screening option for cervical cancer — and it's had a remarkably successful track record.