DNA testing can expand access to cervical cancer screening

HOUSTON – (June 21, 2023) – Rice University biotechnologists have demonstrated a low-cost point-of-care DNA test for HPV infection that could make cervical cancer screening more accessible in low- and middle-income countries where the disease kills more than 300,000 women each year .

HPV, a family of viruses, infects nearly everyone at some point in their life, often without symptoms. But more than a dozen types of HPV can cause persistent infections that lead to cervical cancer, which are preventable and curable if detected early and managed effectively.

Nine engineers from Professor Rebecca Richards-Kortum’s Rice lab spent over two years developing a DNA testing platform that combines two technologies, isothermal DNA amplification and lateral flow detection, in a way that greatly simplifies the equipment and procedure requirements for testing. In a study published this week in Science Translation MedicineRichards-Kortum’s team and co-authors from the National Cancer Institute, Mozambique Ministry of Health, Baylor College of Medicine and University of Texas MD Anderson Cancer Center demonstrated that the platform can produce clinically relevant results in samples collected at both US clinical sites and in clinical field sites in Mozambique.

“We know what we need to do to prevent cervical cancer,” said study first author Kathryn Kundrod, a cancer prevention fellow at the National Cancer Institute and senior adviser for moonshot cancer policy coordination in the White House Office of Science and Technology Policy. “It’s really an access issue at this point, and that’s one of the reasons this study is interesting from a global health perspective. This demonstrates the potential for testing processes to be combined with point-of-care diagnostic and treatment technologies to enable women who have never had access to be screened and treated in a single visit in a setting such as a small clinic or mobile diagnostic van. ”

In the study, researchers showed their six-step test for HPV16 and HPV18 — the two types that cause about 70% percent of cervical cancers — gives results in 45 minutes and only requires two pieces of equipment. One, a small centrifuge, is widely available for about $500. The other, a purpose-built dual-chamber heater called NATflow, allows researchers to use single-use cartridges to avoid false positives arising from workspace contamination, a major challenge for point-of-care molecular testing.

“Most of the diseases detected through screening are precancerous, before people get cancer,” said Richards-Kortum, University Professor Malcolm Gillis of Rice, professor of bioengineering and founding director of the Rice360 Institute for Global Health Technologies. “That’s why the screening program is so effective. People who are regularly screened very rarely develop cervical cancer. It’s people who have never been screened in their lifetime, or who are screened at very infrequent intervals, who are really at risk. That’s why it’s so important to address the differences and devise new ways to screen, diagnose and treat.”

Kundrod, who received his Ph.D. of Rice in 2020, is a former student and postdoctoral researcher in the Richards-Kortum lab who led the development of the everyday HPV test and co-development of the platform with NATflow manufacturer Axxin from Victoria, Australia. Kundrod says that if the NATflow platform and test cartridges were produced at scale, each double space heater would cost about $500 and each test less than $5.

“The platform is another thing that makes this interesting, because it can be easily adapted for DNA testing of other diseases,” he said. “Preventing contamination has been a big issue for DNA-based treatment tests. This is one of the first platforms to address it, and so far the only one to solve it in a way where all parts can be easily produced by injection molding, which is important from a cost perspective.”

Kundrod said Rice’s team’s HPV test won’t be ready for widespread use until researchers modify it to detect more cancer-causing strains of HPV and perform additional clinical tests. She said studies consistently show that HPV screening is the most effective way to prevent cervical cancer and DNA testing is the most effective way to screen for HPV infection.

“We are grateful to the entire team that made this work possible and are committed to continuing development and scale in places where cervical cancer screening is most needed,” said Richards-Kortum.

This research was supported by the National Institutes of Health’s National Cancer Institute (CA016672, CA249367), National Academy of Sciences, United States Agency for International Development (AID-OAA-A-11-00012), MD Anderson Multidisciplinary Research Program, Foundation for Cancer Prevention and the National Science.

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Peer-reviewed papers:

“Integrated isothermal nucleic acid amplification assay to detect HPV16 and HPV18 DNA in resource-limited settings” | Science Advances | DOI: 10.1126/scitranslmed.abn4768

Authors: Kathryn A. Kundrod, Maria Barra, Alexis Wilkinson, Chelsey A. Smith, Mary E. Natoli, Megan M. Chang, Jackson B. Coole, Akshaya Santhanaraj, Cesaltina Lorenzoni, Celda Mavume, Hira Atif, Jane Richards Montealegre, Michael E. Scheurer, Philip E. Castle, Kathleen M. Schmeler and Rebecca R. Richards-Kortum

https://doi.org/10.1126/scitranslmed.abn4768

Image download:

https://news-network.rice.edu/news/files/2023/06/0626_HPV-KkRrkMn-lg.jpg
DESCRIPTION: From left, Kathryn Kundrod ’20, Rebecca Richards-Kortum, and Mary Natoli ’20 in the Rice University laboratory in Richards-Kortum in March 2020. Kundrod, Richards-Kortum, and Natoli are co-authors of a new study demonstrating the effectiveness of DNA testing low-cost point-of-care for HPV infection that allows more cervical cancer screening in low- and middle-income countries where the disease kills more than 300,000 women each year. (Photo by Jade Boyd/Rice University)

https://news-network.rice.edu/news/files/2023/06/0626_HPV-POCtest-1080.jpg
DESCRIPTION: A low-cost point-of-care DNA test for HPV infection found at Rice University gives results in 45 minutes and requires only two pieces of equipment, a small centrifuge (not shown) that costs about $500 and a NATflow, a custom-built double boiler that uses a single cartridge. wear to prevent false positives arising from workspace contamination, a major challenge in point-of-care molecular testing. (Image courtesy of Richards-Kortum Lab/Rice University)

https://news-network.rice.edu/news/files/2023/06/0626_HPV-steps-1500.jpg
DESCRIPTION: A six-step process for a new point-of-care DNA test for HPV infection that allows more access to cervical cancer screening in low- and middle-income countries where the disease kills more than 300,000 women each year. (Image courtesy of Richards-Kortum Lab/Rice University)

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https://news.rice.edu/news/2023/dna-test-could-broaden-access-cervical-cancer-screening

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