HPV point-of-care test in development combines isothermal amplification, lateral flow detection

Hpv Infection Social

Rice University bioengineers said this week that they have demonstrated a low-cost, point-of-care DNA test for HPV infections 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.

Nine engineers from the laboratory of Rice Professor Rebecca Richards-Kortum spent more than two years developing a DNA testing platform that combines two technologies, isothermal DNA amplification and lateral flow detection, to simplify the equipment and procedures needed for HPV testing.

Richards-Kortum’s team and co-authors from the National Cancer Institute, the Mozambique Ministry of Health, Baylor College of Medicine, and the University of Texas MD Anderson Cancer Center showed that the platform could produce clinically relevant results on samples collected at both U.S. clinical sites and at clinical field sites in Mozambique.

They reported the results of the study this week in Science Translational Medicine.

HPV, a family of viruses, infects nearly everyone at some point in their lives, often without symptoms. However, more than a dozen types of HPV can cause persistent infections that result in cervical cancer, which is preventable and curable if it is detected early and managed effectively.

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

The research was supported by the National Institutes of Health’s National Cancer Institute, the National Academy of Sciences, the United States Agency for International Development , the MD Anderson Multidisciplinary Research Program, the Prevent Cancer Foundation, and the National Science Foundation.

“We know what we need to do to prevent cervical cancer,” the study's first author Kathryn Kundrod, a cancer prevention fellow at the National Cancer Institute, said in a statement.

“It’s really a matter of access at this point, and that’s one reason this study is exciting from a global health perspective,” added Kundrod, who is also a senior advisor for cancer moonshot policy coordination at the White House's Office of Science and Technology Policy. “It demonstrates a testing process that could potentially be combined with point-of-care diagnostic and treatment technologies to allow women who’ve never had access to be screened and treated in a single visit in settings like a small clinic or a mobile diagnostic van.”

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