This Pap Test Alternative Is Just as Uncomfortable and Much Less Trustworthy

Sometimes doing things the old way is better. Sometimes not so much. Image via Flickr.

Recent news coming out of the FDA sounds like it just might give women a cause to rejoice. Switzerland-based healthcare company Roche has developed the cobas HPV test, just approved by the FDA, as an alternative to the Pap test for women 25 and over. It samples a woman’s DNA to determine whether she carries abnormal cells or high-risk HPV, which is the cause of most cases of cervical cancer.

Frankly, I would have jumped at the chance to never again have my vagina pried open by a cold, ominous, salad-tongs-resembling plastic tool, only to have cells scraped from my cervix after more invasive poking around with another frigid tool.

But, I spoke with Dr. Nancy Durand, a gynecologist at Sunnybrook Health Sciences Center in Toronto, and she said if I thought I was off the hook in that regard, I’m sorely mistaken.

“The test is done exactly the same way as a Pap test,” Durand tells me on the phone. “Some women heard of it and thought they didn’t need a pelvic exam. We still use the speculum, and we still take the sample the exact same way. The lab does a different test, but not the provider.”

While it may seem like nothing has changed, Durand says the Roche method is actually a better test for a primary screening, as the FDA recommends. Sunnybrook has used the test for the past year.

“It’s more accurate at picking up the women who are at risk for either high-grade abnormal cells or cervical cancer. We miss fewer cases versus when the traditional Pap test was used first.”

If the test is positive, and it appears there are risky cells, a Pap test will be run, as well. But that doesn’t mean you have to take a second visit to your healthcare provider. It just means the lab has to run a second test, as they already have the sample. Durand stresses that a woman can test negative and still have HPV, just a lower-risk version. But it can still cause genital warts, and there is no way to know you have it as it doesn’t show up on the test. The test only identifies type 16 and 18 HPV, which are the riskiest ones that cause cervical cancer, as well as some other high risk strains. Low-risk ones are not detected.

Durand explains that the prevalence of HPV is much greater among women under 30, and as such, there is a higher chance women in that age group will have higher-risk strains of HPV. Because we’re young, though, she says we can fight those strains with greater ease, and that symptoms generally clear after two years.

The critique, she says, is that the test will detect a lot of high-risk viruses that most often will not result in that woman having cancer. The risk goes up the older you get—so much so, in fact, that in the Netherlands, they don’t do any screening at all until women are 30 and older.

Meanwhile, in Canada, healthcare providers can’t officially recommend the Roche test because it’s not yet funded. Durand says that’s presenting a dilemma for providers, as the Roche test is more effective than the Pap, but providers have to follow provincial guidelines.

“We can’t recommend that you have a test, across the board, for all the people in Canada, that they have to pay for.”

She says that’s an exclusionary practice, as the $90 to $100 retail price of the test would be out of reach for too many Canadians. If it becomes funded, the test will still have a cost associated, but patients will pay the wholesale price.

The upside to that is that the Roche method is more accurate, and misses fewer cases. Durand says instead of needing a test every three years, a patient may only need one every five.

Roche is billing itself as a company that “does now what patients need next.” But a number of women’s health organizations are saying it’s too soon for the Pap test to be replaced, and that Roche’s method hasn’t been studied thoroughly enough, despite the FDA approval. Groups against the speedy implementation of Roche’s method include the American Medical Women’s Association and Our Bodies Ourselves, amongst others. They say this is a “radical” shift, and that it could lead to confusion, higher costs, and overtreatment in younger women. (Younger women will often carry HPV, but run little risk of developing cancer).

Roche’s method of using DNA to detect the human papillomavirus, or HPV, which causes the majority of cervical cancer cases, has actually been available for years, and the testing is usually done to confirm the results of a Pap test, anyway. The difference is that Roche now wants it to be a standalone option.

"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 who oppose the test in a letter to FDA Commissioner Dr. Margaret Hamburg, according to The Associated Press. The letter is signed by 17 patient advocacy groups; including Consumers Union, the Cancer Prevention and Treatment Fund and the National Alliance for Hispanic Health.

Alas, it looks like more research is needed before this sits well with everyone. It also looks like there will be no reduction in the time women are required spend naked from the waist down, cold, feet in stirrups, having our vaginas unlovingly poked and prodded with various torture devices. But at least that time might be more productive going forward, as time goes on and the test becomes funded.

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This Pap Test Alternative Is Just as Uncomfortable and Much Less Trustworthy

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