FDA Gathers Input on Feasibility of Home Pap Testing

Alicia Ault

January 12, 2018

Should home Papanicolaou (Pap) smear testing be available, and could  it increase detection of cervical cancer? Could a woman at home get an appropriate and accurate cervical cell sample? Will self-collection do more harm than good if women don't follow up on abnormal results?

The US Food and Drug Administration (FDA) held a day-long meeting yesterday to address those questions and many others — even as most guidelines and public health entities are beginning a shift away from Pap testing alone to human papillomavirus (HPV) testing alone or cotesting.

Pathologists and clinicians invited to speak at the meeting expressed some concern about self-collection.

"Using conservative assumptions, you might have a larger number of women harmed by this device than helped," said Paul Staats, MD, associate professor of pathology, University of Maryland School of Medicine, Baltimore, at the meeting.

If women decide to skip a follow-up for an abnormal result, then just providing access to a Pap test alone is not the same as cancer screening, he said. "We have to make sure we're not using getting a Pap test as a proxy for improving these women's lives," said Dr Staats.

Self-Pap and Self-HPV Tests on Horizon

Shyam Kalavar, MPH, CT (ASCP), a scientific reviewer with the FDA's Office of In Vitro Diagnostics and Radiological Health, said that although the meeting was focused on self-collection for liquid-based Pap testing, it was also laying the groundwork for how the agency might approach self-collection devices of any type for cervical cancer screening.

The agency did not say whether any manufacturer has sought approval for a self-collection Pap smear device or system. But Jeff Andrews, medical director for women's health at Becton-Dickinson, which makes the SurePath Pap test, endorsed the concept of self-collection during the open public speaker portion of the meeting.

Edward Evantash, MD, medical director at Hologic Inc, opposed the notion of at-home testing. Hologic makes the Aptima Pap testing system.

Two entrepreneurs at the meeting said they were working with the FDA to get their self-collection system approved. The goal is not to sell it over the counter but to have a device that physicians could get out to patients who might have trouble accessing screening for various reasons, said Elizabeth Klein, CEO of GyneConcepts Inc. "Let's just open our minds today and figure out: Is self-collection valuable, and does it have a place in our medical community?" she said.

Some 80% of American women receive cervical cancer screening, but overall, there are still some 12,000 malignancies each year. About 4000 US women die of the cancer annually,  according to the National Cancer Institute.

Given that it's a largely preventable cancer, "I do think we need to come up with a strategy, and I think self-collection is a strategy," said Mona Saraiya, MD, MPH, from the Centers for Disease Control and Prevention (CDC) Division of Cancer Prevention and Control, at the meeting. The United States does not have a screening registry, so the CDC estimates how many and which women are getting care through surveys, she said.

The surveys show the trend in screening since 2000 has been stable but that certain groups of women are not being reached, she said. Those include women with lower educations, those who are underinsured, those who are LGBTQ, those who live in Appalachia or on the United States–Texas border, or those who are Chinese or Muslim.

Speakers at the meeting debated the merits of creating a test system that would target only certain groups of women.

Accuracy, Follow-up Issues

Even clinicians can have difficulty getting perfect cervical cell samples, said Mark Schiffman, MD, MPH, senior investigator, National Cancer Institute, at the meeting. It requires scraping cells from the cervical transformation zone, which might be hard to get exactly right without any visual aid, he said.

"I'm skeptical about a self-sampling strategy," Dr Schiffman said.

Dr Staats agreed that women could have difficulty getting an appropriate cell sample. He also brought up what he said could be other challenging issues, including ensuring that samples are not ruined by temperature extremes and that the liquid prep material is safe for home use.

A huge issue is whether labs would be responsible for delivering results to patients, said Dr Staats. "Can you imagine a lab calling you and saying you have squamous cell carcinoma, you should go see a doctor about that?" he asked.

Follow-up was also a major concern for clinicians. For many, "once they have an abnormal test, a lot of people don't know where to go," said Jacqueline Cunkelman, MD, MPH, medical officer and practicing gynecologist, with the FDA's Office of Device Evaluation. In practice, delivering news about abnormal cytology is "not a simple call or letter," she said, noting that a lack of follow-up by a clinician could trigger legal action.

"Ultimately the clinician can be held liable, and that's something that has to be taken into account," said Dr Cunkelman. 

Self-collection devices can help overcome barriers to screening, "but they're not the same as an office visit with the physician," said Barbara Crothers, DO, president of the American Society of Cytopathology.

"Our concern is that women may opt out of clinical visit," she said, adding that could lead to "a potential outcome of increased cancer rates."

The FDA said it would take speakers' advice to heart. "We will incorporate this when we work on study design with sponsors, so we can get a self-collection device for Pap into the market," said Reena Philip, director, FDA's Division of Molecular Genetics and Pathology in the Office of In Vitro Diagnostics and Radiological Health.

"We all agree that there is a need to serve the underserved population," she said.

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