FDA Approves Self-Collection for HPV Testing: What It Means for Cervical Screening

The change, stated precisely

On 14 May 2024 the FDA expanded the approved indications for two HPV tests: the BD Onclarity HPV Assay and the Roche cobas HPV Test. FDA announced it in its roundup of 17 May 2024.

The change is narrower than most headlines suggested. Read the approval order and the wording is careful. A person may swab their own vagina in a health care setting. That swab can then be tested in place of a cervical sample. But only when a cervical sample is unsafe to take, or cannot be taken at all.

Three limits sit inside that. The sample is a vaginal swab, not a cervical one. It is taken in a clinic. NCI lists doctors' offices, urgent care, pharmacies and mobile clinics. And it is a fallback, not a swap anyone can ask for.

What a cervical screening test is actually looking for

There are three approved approaches, and NCI describes each.

The HPV test looks for high-risk types of human papillomavirus. Both tests find the same 14 types. The BD test identifies types 16, 18, 31, 45, 51 and 52 one by one, and reports the remaining types in groups.

The Pap test, also called cervical cytology, collects cells. A lab then looks at them under a microscope. It can spot cell changes caused by HPV, and it can spot cancer cells.

The HPV/Pap cotest runs both at once.

Self-collection changes only how the sample reaches the laboratory. NCI is explicit that the way the test looks for HPV is unchanged. Our page on the HPV test covers what the result means.

Why access is the point

NCI reports that almost 30% of eligible people with a cervix in the United States are not screened at the recommended intervals. Of new cervical cancer diagnoses, half occur in people who were never screened or were screened inadequately.

The reasons NCI's researchers give are mostly not about willingness. They point to health care deserts with no regular provider. They point to poverty and rural distance. They also name personal or religious beliefs, a history of trauma, and health conditions that rule out a pelvic exam. Some clinics lack the room or kit to do one.

NCI notes that several countries — the Netherlands, Denmark, Sweden and Australia — already use self-collected samples widely.

What happens if the test is positive

This is the part self-collection does not solve.

A positive HPV result is not a diagnosis. It means a high-risk type is there. The next step usually needs a clinician. That may be a Pap test, if one was not already done. It often means colposcopy: the cervix is viewed under a bright light and lens, and a small tissue sample may be taken.

If precancerous cells turn up, removing them is a procedure, not a swab. NCI's screening expert calls the whole route from test to treatment a path that can break down at any step.

So self-collection widens the front door. It does not shorten the hallway behind it.

When to get screened

NCI summarizes the U.S. Preventive Services Task Force recommendations this way:

• Ages 21 to 29: a first Pap test at 21, then a Pap test every three years.
• Ages 30 to 65: an HPV test every five years, or an HPV/Pap cotest every five years, or a Pap test every three years.
• Over 65: a conversation with a provider. People screened regularly with normal results are usually told they can stop.

The American Cancer Society's updated guideline starts at 25 with an HPV test, repeated every five years through 65.

Some people need closer follow-up. NCI names HIV infection and a weak immune system. It names exposure before birth to a drug called diethylstilbestrol, or DES. It also names a recent abnormal result or biopsy, and a past cervical cancer.

One point trips people up. The HPV shot does not block every high-risk type. So people who have had it follow the same screening schedule as everyone else. Our guide to cervical cancer screening sets out the intervals, and HPV and cancer covers the virus itself.

If you have had a total hysterectomy for reasons unrelated to cancer or abnormal cervical cells, NCI says cervical screening is no longer needed.

What this does not mean

This approval did not authorize testing a sample you collect at home. NCI's July 2024 write-up states plainly that the collection must happen in a health care setting.

Home collection is being studied, not approved. NCI leads an effort called the Last Mile Initiative. Its SHIP trial network opened 25 sites in early 2024. The trial has people swab themselves in a set-up made to feel like home. A clinician then takes a cervical sample at the same visit, and the two are compared. NCI says the data will go to FDA, with the aim of extending the approvals to the home.

In April 2026, FDA approved a further supplement to the BD Onclarity approval. It widens the settings where a person may take their own vaginal swab, and it adds a lab workflow for those swabs. That is a real change in the record. What it allows in practice is set by the labeling, not by a headline.

A self-collected swab is also not a Pap test. It reports whether high-risk HPV is present. It does not examine cells for changes.

Sources

• FDA Roundup: May 17, 2024
• openFDA Device PMA: P160037/S017 — BD Onclarity HPV Assay
• openFDA Device PMA: P190028/S009 — Roche cobas HPV
• openFDA Device PMA: P160037/S024 — expanded self-collection settings (2 April 2026)
• NCI Cancer Currents: FDA Approves HPV Tests That Allow for Self-Collection in a Health Care Setting
• NCI: Cervical Cancer Screening

How this article was prepared

An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.

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