What at-home cervical cancer screening means for physicians

In 2023, 14.8% of U.S. women ages 30 to 65 said they had never been screened for cervical cancer, up from 5.3% in 2005, according to a research letter published Aug. 27 in JAMA Network Open. Among women ages 21 to 29, the never-screened share climbed from 12.5% to 31.9%. First author Kalyani Sonawane, Ph.D., of the Medical University of South Carolina's Hollings Cancer Center said in a news release that her team wasn't sure why the share has been rising. In earlier, unpublished work, she said, many unscreened women gave no particular reason or said their clinician hadn't brought it up.

Waters Corp. announced in April that the Food and Drug Administration (FDA) had cleared a kit that lets patients collect their own vaginal sample at home for cervical cancer screening and mail it to a lab for human papillomavirus (HPV) testing. Samples collected with the Onclarity HPV Self-Collection Kit are tested with the Onclarity HPV assay, which the FDA also approved for use with at-home samples. The assay reports six high-risk HPV types individually and eight more in three pooled groups. The FDA approved the first at-home self-collection device for cervical cancer screening, Teal Health's Teal Wand, in May 2025.

Jeff Andrews, M.D., FRCSC, is vice president of medical affairs at Waters Advanced Diagnostics, one of four divisions Waters formed in February when it completed its combination with the Biosciences and Diagnostic Solutions businesses of Becton, Dickinson and Co. (BD). BD remains the legal manufacturer of the kit and assay until required regulatory transfers are complete, according to Waters. An obstetrician-gynecologist, Andrews has performed cervical cancer screenings for decades. Since June, Color Health, SNT Biotech and LetsGetChecked have announced partnerships with Waters to offer the at-home kit.

Where coverage and policy stand for at-home HPV testing

The Health Resources and Services Administration added patient-collected HPV testing to its Women's Preventive Services Guidelines in January, and most private health plans must cover it for average-risk women ages 30 to 65, along with any follow-up testing needed to complete screening, without cost sharing beginning Jan. 1, 2027. The American College of Obstetricians and Gynecologists welcomed the added coverage but warned that expanding at-home access without systems to connect patients to further testing and treatment could delay diagnosis. The American Cancer Society's December guideline update calls for repeat testing three years after a negative self-collected result, compared with five years after a negative clinician-collected HPV test.

A Capitol Hill lunch briefing on Sept. 17 will look at expanding access to at-home self-collection, which its organizers say remains uneven because of regulatory complexity, reimbursement gaps and inconsistent adoption across federal programs. Waters is co-sponsoring the briefing, in the Rayburn House Office Building, with the American Society for Colposcopy and Cervical Pathology (ASCCP), the American Cancer Society Cancer Action Network and other groups. ASCCP President Christine Conageski, M.D., is scheduled to speak.

Medical Economics spoke with Andrews about how physicians order the kit and act on a positive result, and why he says lack of awareness is the top reason women go unscreened.

Our conversation, lightly edited for length and clarity, follows.

Where do cervical cancer screening rates stand right now, and what's driving that?

Andrews: The share of eligible women in the U.S. who are being screened stands at about 70%, and the U.S. goal and worldwide goal is 90%. So we need to cross that barrier. Some people have called that "the last mile," trying to reach the underscreened and unscreened. Unfortunately, of the cancers that are diagnosed every year, 60% are from this small group of underscreened women, so they're very important to reach.

Cervical cancer is preventable. If we can screen everybody, we could prevent virtually all the cancers, so the goal is elimination of cervical cancer.

Can you walk me through the process and what this new collection tool looks like for the patient? If she gets the kit in the mail, what happens next?

For many decades, the screening test for cervical cancer was the Pap test, which is done by a doctor doing a speculum exam, visualizing the cervix, collecting directly from the area around the cervical canal and then making a slide from that, which is read by a cytologist.

More than a decade ago, we began switching from cytology-based screening to HPV-based screening, because HPV is the virus that causes all cervical cancer, as well as five other cancers. HPV screening can use the exact same collection, with a clinician doing a speculum exam and collecting from the cervical canal. But we also learned that the collection could be done by the patient herself, using a swab or a brush in the vagina. So we developed a technique and a kit for that outside the U.S., introduced it and then worked with the FDA to get approvals inside the U.S.

Initially, we had an approval to do that in the clinic setting, where the patient could collect the sample privately, say, in a restroom in the doctor's office or the clinic. Now we've extended that to the home, or wherever the patient would like to receive the kit.

So the doctor orders the self-collection, and the order goes to a lab. The lab sends the kit out through the mail or by delivery to the patient's desired address. The patient receives the kit with instructions in both diagrams and words. They do the collection and send the sample back to the lab. The lab processes that sample and sends the report to the doctor, and the doctor contacts the patient with the result of their screening.

On the physician side, how does the order get placed, and how does the result come back? Can that be done via telehealth?

Right now, almost every doctor is using an electronic health record or electronic medical record. These have written words as well as codes behind them, and the codes in the electronic medical record connect to a code at the lab. Doctors are already ordering tests to be done at the lab: blood tests, urine samples, 24-hour urine collections and even some at-home testing. So this is already there. It's simply a matter of adding a code for HPV self-collection. The doctor just clicks on that in the electronic medical record, and the lab takes it from there.

This can be the patient's own established clinician, whom they contact to get this done. It could be done at a visit with the clinician, or it could be telehealth. That could be the patient reaching out specifically to get this test and being connected to telehealth, or it could be their employer or insurer noticing that they are beyond the screening interval and offering this to them through telehealth.

If a result comes back positive, what's the next step for the physician and for the patient?

In the U.S., the guidelines for what to do if you get an abnormal result, whether it's a cytology result or an HPV result, come from ASCCP, the American Society for Colposcopy and Cervical Pathology. Their guidelines are available on their website for free, or on an app that can run on a tablet or phone.

If the HPV test is positive and it's one of the highest-risk genotypes, HPV 16 or 18, there's an option to direct that patient straight to colposcopy based on the HPV result alone, because their risk is high enough to require that. That appointment can be made, and we can talk about that if you want.

If the genotype is in the lowest-risk group, 56/59/66, the patient can simply be advised to repeat the HPV test in 12 months. If it's one of the genotypes in between, it's recommended that the patient see someone to have a sample collected for cytology, and the cytology is used to triage the HPV result. The cytology could be negative, low grade or high grade, and that would further determine the risk and whether they need a colposcopy or not.

These guidelines are easy to follow. And the Onclarity HPV assay is the only one that fulfills the guideline requirement for that 56/59/66 group I mentioned.

If the result is on that higher end, what is the follow-up procedure like?

Colposcopy is looking at the cervix with a bright light and magnification, and then using basically an acetic acid or vinegar solution to bring out some white highlights. Based on the appearance of the cervix under magnification, an expert can determine whether biopsies are required. If a biopsy is done, the histopathology of that biopsy determines whether it's negative, CIN [cervical intraepithelial neoplasia] 1, CIN 2 or 3.

If it's CIN 2 or 3, unless there's some factor like pregnancy or the person is very young, treatment is typically offered. The treatment is an excision of that area of the cervix, a few millimeters deep, and that removes the precancer and prevents the cancer.

A Sept. 17 congressional briefing will look at what's getting in the way of these screenings, including regulatory complexity, reimbursement gaps and uneven adoption across federal programs. From where you sit, which of those, or something else, is the biggest obstacle right now?

We've sponsored some independent surveys, and I was a little surprised to learn that the No. 1 reason is lack of awareness. I thought everybody knew that you should be screened for cervical cancer, but not so.

Then there are some practical things that get in the way, like people not being sure their insurance covers it, or transportation issues, or they're holding down three jobs and just can't squeeze it in. There's a large number of women who've experienced trauma and sexual abuse, and they avoid a speculum exam. That's probably 25% to 30% of women, at least. Then there are women living in rural areas, or who are underserved and disadvantaged.

So we need to reach these women, make sure they're aware of the importance of screening and make sure they know they can actually access screening in a number of ways, because the U.S. covers breast and cervical cancer screening with zero out-of-pocket expense on the part of the patient. It's just a matter of navigating to where that person can acquire the screening.

It's important that you're doing this interview, because not everybody knows about self-collection yet. We need to get the word out, because we're anticipating that this option will increase screening coverage and reach more women.

On the other side of that, what actually moves the needle? If, in a perfect world, you could change one thing over the next year, what would it be?

I'll turn that around, because the question I get asked is, "Where can I access this test?" I think if we had access in every county in every state in the United States, that would move the needle. That's what we've been working on.

We don't directly give tests to patients. We have intermediaries: national labs, hospital networks, federally qualified health centers and partners that reach out to patients with screening opportunities, like LetsGetChecked, Color Health and SNT Biotech. We've been establishing these partnerships, and we have more announcements coming. When we can have self-collection kits available anywhere someone would ask, that's when the needle is going to move.

Is there anything we didn't talk about, or glossed over, that you think is important for physicians to keep in mind?

I think we covered it. I want to emphasize this as an option. We're not taking anything away. Some younger women are still using Pap-based or cytology-based screening, or HPV screening with their clinician. If that's something people have been doing, then they're already in that screened population. We're trying to offer an option, in particular to reach the unscreened, the underscreened and those who are disadvantaged in our health care system and experiencing health care disparity.