Low-Cost POC DNA Test for HPV Infections Could Broaden Access to Cervical Cancer Screening

Almost everyone gets infected by Human Papillomavirus (HPV), a group of viruses, at some point in their lives, often without exhibiting any symptoms. However, persistent infections by over a dozen types of HPV can lead to cervical cancer. Early detection and effective management of this condition can prevent it and even cure it. A new affordable, point-of-care DNA test for HPV infections now holds promise to make cervical cancer screening more accessible in low and middle-income countries, where the disease claims the lives of over 300,000 women annually.

A team of bioengineers at Rice University (Houston, TX, USA) spent over two years developing a DNA testing platform that merges two technologies - isothermal DNA amplification and lateral flow detection. This combination significantly simplifies the equipment needs and testing procedures. The researchers demonstrated that the platform could deliver clinically relevant results on samples collected from clinical sites in the U.S. and Mozambique. Their six-step test for HPV16 and HPV18 - two types responsible for approximately 70% of cervical cancer cases - yielded results in just 45 minutes.

Image: The low-cost, POC DNA test for HPV infections delivers results in 45 minutes (Photo courtesy of Rice University)

The HPV test required only two pieces of equipment. The first, a small centrifuge, is widely available for about USD 500. The second, a specifically-designed dual-chamber heater called NATflow, enabled the researchers to use disposable cartridges, mitigating the risk of false positives due to workspace contamination - a significant hurdle in point-of-care molecular testing. If produced on a large scale, each NATflow platform and test cartridges would cost around USD 500 and less than USD 5 per test, respectively. However, before it is ready for widespread use, the HPV test needs to be adapted to detect more cancer-causing types of HPV and undergo additional clinical tests. As the researchers point out, studies have consistently proven that HPV screening is the most effective strategy to prevent cervical cancer, and DNA testing is the most efficient way to screen for HPV infections.

“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 advisor for cancer moonshot policy coordination at the White House Office of Science and Technology Policy. “It’s really a matter of access at this point, and that’s one reason this study is exciting from a global health perspective. 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.”

“The platform is the other thing that makes this exciting, because it can easily be adapted for DNA tests for other diseases,” added Kundrod. “Preventing contamination has been a huge problem for DNA-based point-of-care tests. This is one of the first platforms to address that, and so far it’s the only one to solve that in a way where all the pieces can be easily manufactured with injection molding, which is important from a cost perspective.”

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Rice University