At-Home Urine Test Detects HPV Head and Neck Cancer DNA

Author: Michigan Medicine - University of Michigan
Published: 16 Apr 2024 - Updated: 8 Nov 2026
Publication Details: Peer-Reviewed | Experimental Study

Table of Contents:
Synopsis - Definition - Overview - FAQs - Insights, Updates - Related Content

Synopsis

This research from the University of Michigan Health Rogel Cancer Center, published in the peer reviewed journal JCI Insight, describes a urine test that detects tiny fragments of tumor DNA shed by HPV-positive head and neck cancers. Using whole genome sequencing, the team found that tumor DNA passing from the blood into urine is mostly ultra-short, under 50 base pairs, which conventional liquid biopsy tests are not designed to catch. The mail-in, at-home test detected cancer recurrences earlier than imaging in some patients and also found tumor DNA in people with breast cancer and acute myeloid leukemia. It could make follow-up easier for cancer survivors, including those with limited mobility or who live far from treatment centers.*

At a Glance

1 - There is currently no reliable screening method for head and neck cancer.
2 - Participants collect a urine sample at home and mail it to the laboratory.
3 - HPV is best known for causing cervical cancer but also causes cancers of the mouth and throat.
4 - The test has been offered for research to patients living more than a hundred miles from Ann Arbor.

Topic Definition

Circulating Tumor DNA: Circulating tumor DNA (ctDNA) is fragments of genetic material released by cancer cells into the bloodstream, some of which pass into urine and other body fluids. Detecting ctDNA through a liquid biopsy can help find cancer, monitor how well treatment is working and spot recurrence earlier than imaging, without the need for a tissue biopsy.

Overview

Researchers from the University of Michigan Health Rogel Cancer Center have created a urine-based test that detects pieces of DNA fragments released by head and neck tumors. The test could potentially facilitate early detection of this cancer type, which currently does not have a reliable screening method.

Human papillomavirus (HPV) is widely recognized for causing cervical cancer, but is increasingly found to cause cancers in the mouth, throat and other head and neck regions. Early detection is critical because detecting a cancer at an earlier stage can lead to better outcomes for patients.

Using whole genome sequencing, the Rogel group showed that cell-free DNA fragments released by tumor cells, which are passed on from the bloodstream into urine through the kidneys, are predominantly ultra-short, with fewer than 50 base pairs. Given their small size, these fragments are likely to be missed using conventional urine or blood-based liquid biopsy tests in detecting circulating tumor DNA (ctDNA).

The research was led by Muneesh Tewari, M.D., Ph.D., professor of hematology and oncology, J. Chad Brenner, Ph.D., associate professor of otolaryngology-head and neck surgery, and Paul L. Swiecicki, M.D., associate medical director for the Oncology Clinical Trials Support Unit at Rogel. Initial results were published in JCI Insight.

"In this study we provide evidence to support the hypothesis that conventional assays do not detect ultrashort fragments found in urine, since they are designed to target longer DNA fragments. Our team used an unconventional approach to develop a urine test for HPV-positive head and neck cancer ctDNA detection," said study co-first author and research specialist Chandan Bhambhani, Ph.D.

Still in the discovery phase, this mail-in test has already been distributed for research purposes to patients within a hundred-plus miles from Ann Arbor, allowing scientists to gather significant data on the efficacy of the at-home kit. Participants collect a urine sample and have it shipped back to the U-M laboratory, where the testing can be done to detect the presence or absence of head and neck cancer.

"One of the most remarkable outcomes of this study is that the test that has been developed has detected cancer recurrences far earlier than would typically happen based on clinical imaging. As such, these promising results have given us the confidence to broaden the scope of the study, seeking to expand distribution even further," said Brenner, co-senior author of the study.

While initial studies have focused on head and neck cancer, the paper also describes a new method that could be applied to expand the test to detect other cancers as well. For example, the authors show that the test can detect ctDNA in the urine of patients with breast cancer and acute myeloid leukemia. This suggests new opportunities to also study the application of urine-based testing for these additional cancers.

"Many people are not aware that urine carries information about many different cancer types, although it is made in the kidneys. Our findings about the difference in ctDNA fragment sizes and the test we developed for HPV-positive head and neck cancer detection provide crucial information on how urine-based diagnostic assays can be developed for different cancers," Bhambhani said. "Further, these types of tests are likely to have a much higher compliance in patients requiring follow-up testing post treatment, due to the convenience of self-collection of samples, when compared to blood-based assays."

Authors

Chandan Bhambhani, Qing Kang, Daniel H. Hovelson, Erin Sandford, Mary Olesnavich, Sarah M. Dermody, Jenny Wolfgang, Kirsten L. Tuck, Collin Brummel, Apurva D. Bhangale, Kuang He, Marc G. Gutierrez, Ryan H. Lindstrom, Chia-Jen Liu, Melissa Tuck, Malathi Kandarpa, Michelle Mierzwa, Keith Casper, Mark E. Prince, John C. Krauss, Moshe Talpaz, N. Lynn Henry, Maria D. Giraldez, Nithya Ramnath, Scott A. Tomlins, Paul L. Swiecicki, J. Chad Brenner, and Muneesh Tewari

Funding

NIH grants R33 CA229023, R21 CA225493; NIH/National Cancer Institute grants U01 CA183848, R01 CA184153, and P30CA046592; American Cancer Society RSG-18-062-01-TBG; American Cancer Society Mission Boost grant MBGI-22-056-01-MBG; and the A. Alfred Taubman Medical Research Institute.

Disclosures

MT, JCB, PLS, QK, C Bhambhani, DHH, ES, and KH are inventors of HPV TR-ctDNA assay technology, for which the University of Michigan is pursuing patent protection, and NLH reports consulting for Myovant Sciences and AstraZeneca.

More on this topic: Head, Neck and Oral Cancer Publications - Cancer Publications

Frequently Asked Questions

NOTE: Researched FAQs by Disabled World (DW)

What is a liquid biopsy?

A liquid biopsy is a test on blood, urine or another body fluid that looks for signs of cancer, such as tumor DNA, instead of removing tissue.

Can the HPV vaccine prevent head and neck cancer?

The HPV vaccine protects against the virus types that cause most HPV-related cancers, and it is expected to reduce HPV-related throat cancers over time.

What are early signs of head and neck cancer?

Warning signs include a lump in the neck, a sore throat or mouth sore that does not heal, trouble swallowing, ear pain on one side and a lasting change in voice.

Is the urine test available to the public?

Not yet. It is a research test being studied with patients, and it would need further validation and approval before routine use.

Why does early detection of recurrence matter?

Finding cancer that has returned at an earlier stage can allow treatment to start sooner, when there may be more options and better chances of control.

Risk is higher in people with oral HPV infection, and HPV-related throat cancers are more common in men. Smoking also raises the risk of head and neck cancers.

How is HPV-positive head and neck cancer treated?

Treatment often includes surgery, radiation and chemotherapy, alone or combined, and HPV-positive cancers usually respond better than HPV-negative ones.

What is whole genome sequencing?

It is a method that reads the entire DNA sequence of a sample, allowing researchers to find genetic changes and measure DNA fragment sizes.

Insights, Analysis, and Developments

Editorial Note: Regular blood tests and scans after cancer treatment can be a burden, especially for people who live far from a cancer center or find travel difficult because of disability or age. A test that can be done at home and mailed in could make it easier to stay on schedule, and the finding that tumor DNA in urine is unusually short explains why earlier tests missed it. The test is still in the research phase and needs larger studies before routine use, but it points toward simpler monitoring for several cancer types.*

Attribution/Source(s): This peer-reviewed publication was selected for publishing by the editors of Disabled World (DW) due to its relevance to the disability community. Originally issued as a press release by Michigan Medicine - University of Michigan and published on 16 Apr 2024. Last updated on 8 Nov 2026. This content may have been edited for style, clarity, or brevity.

* Editorial additions by Ian C. Langtree.