Smaller, Faster, Cheaper

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Catherine Klapperich empowers doctors and patients with point-of-care testing

By Kate Becker – 
Courtesy BU Research

“A private little revolution any woman can easily buy at her drugstore.”

That’s how a 1978 ad described the new-to-market home pregnancy test. Today, that revolution is replayed in millions of American bathrooms every year—so many that it hardly feels revolutionary anymore.

But Boston University engineering professor Catherine Klapperich (BME, ME, MSE) understands just how powerful it is to have direct access to your medical information. She’s working to make that “little revolution” a lot bigger through simple, portable tests for conditions like HPV, malaria, and chlamydia that patients can use worldwide.

“In a fragmented healthcare system like ours and like many around the world, you have to be your own advocate,” says Klapperich, who also serves as director of the Center for Future Technologies in Cancer Care (CFTCC) and associate dean for research and technology development at the College of Engineering. “Being the best advocate you can be requires information. Information is power.”

Klapperich’s tests are called point-of-care diagnostics. They are designed to be as easy and portable as those pee-on-a-stick tests, but the chemical machinery inside them far outstrips the strip. Her tests zero in on specific sequences of DNA, called nucleic acids, that single out the cause of infections. Nucleic acid tests usually require lab equipment that costs tens of thousands of dollars; Klapperich’s miniversions fit in your hand and give results in a matter of minutes. As the founder of Jane Diagnostics, a private company, Klapperich is also working to scale up production of the tests she’s developing in her lab.

Catherine Klapperich, director of the Center for Future Technologies in Cancer Care (CFTCC) and professor of engineering at Boston University, working with a PhD candidate in her lab where they are developing point-of-care testing for malaria, chlamydia, gonorrhea, HPV, and more

In Klapperich’s lab, students and researchers are developing tests for malaria, chlamydia, gonorrhea, and more. “There are all kinds of applications” for paper-based testing, says Klapperich, here with PhD candidate Justin Rosenbohm (ENG’20). “And it makes the students who come work for me a much broader group of people.” Photo by Jackie Ricciardi

One of Klapperich’s first targets is human papilloma virus (HPV), which is responsible for almost all cervical cancers. Cervical cancer is highly treatable when it’s caught early. That’s why, in places like the United States, where nucleic acid testing is readily accessible, doctors advise women to get regular HPV tests. (In fact, the new tests are beginning to replace the old standard, the pap smear.) A woman who tests positive for a cancer-causing HPV strain will be closely monitored so that if cancer starts to grow, she can get treated right away.

In parts of the world without these resources, doctors typically diagnose HPV based on a visual exam of the cervix. That means more false positives and more false negatives, says Klapperich, and thus more cervical cancer death and disease for women in low-resource countries, where some 85 percent of new cervical cancers and cervical cancer deaths occur. In India, for example, cervical cancers kill 74,000 women each year—a third of the world’s deaths from the disease. Almost every one of those cancers started out as HPV, a sexually transmitted infection (STI).

“STIs have such a huge impact on women’s health, and they don’t have to,” says Klapperich. “Some lead to sterility and other complications, and because many are asymptomatic, women are being harmed without knowing it. Knowing your status, being able to test yourself, puts the power back into the hands of the woman.”

As for why she has taken up this work, Klapperich says: “If women don’t pioneer in this area, then who will?”

290 million women are infected with HPV – World Health Organization

Curiosity and collaboration

Designing and building the devices requires a blend of biology expertise, engineering know-how, and fundraising finesse—plus relationships with doctors and hospitals. Klapperich has a gift for bringing together people with all of these skills, and then bridging the gaps between them.

Many people look at Klapperich’s career—the titles, the awards, the patents—and imagine her as a little girl, taking apart the VCR, building robots in the basement, and analyzing pond scum with a mini-microscope. But that’s not who Klapperich was. She planned to major in journalism, but switched to engineering after seeing a lab demonstration of cement hardening under an electron microscope. (It was cooler than it sounds.). She wants students to know that the key to a great career isn’t fate or brilliance, but curiosity and persistence. She wants them to know they don’t have to ace AP chemistry to be an engineer. (She didn’t even take it.) And she wants them to know that doubt is allowed.

“It’s a real joy working with her,” says Jose Gomez-Marquez, cofounder of the Cambridge, Mass., device maker MakerHealth. “With other researchers, it’s often this gamesmanship of, ‘How can I show you I’m smarter than you?’” But that isn’t Klapperich, says Gomez-Marquez, who says her intellectual unpretentiousness makes it easier to solve complex problems. “As a collaborator, she truly tries to get everybody involved to their fullest potential,” says Mario Cabodi, a BU research assistant professor of biomedical engineering, who has been working with Klapperich since 2010. “She’s all about giving people opportunities.”

Catherine Klapperich working with a student in her Boston University lab testing point-of-care diagnostics

Klapperich with student Marjon Zamani (ENG’20) in the lab. Klapperich wants students to know that, in science, tenacity and curiosity are more important than acing AP chemistry. “At every step of the way, it’s all about persistence: staying in, not quitting,” she says. Photo by Jackie Ricciardi

Klapperich’s team is partnering with Sri Ramachandra Medical College and Research Institute in Chennai, India, to test Klapperich’s point-of-care HPV diagnostic. The device is about the size of a candy bar and can detect the virus at a patient’s bedside in about 30 minutes. Here’s how it works: A doctor—or even the patient—collects a sample of cells from the cervix, then mixes the sample in a test tube with a chemical that cracks open the cells and makes their freed DNA clump together. Then, a doctor or technician dabs the resulting liquid onto a strip of testing paper and uses alcohol to rinse away the proteins, carbohydrates, fats, and other cellular debris. What’s left behind is pure DNA. If a patient’s cells are infected with HPV, that DNA will include the distinctive sequence of the virus, and the result will show up on the test strip: one line for negative and two for positive, just like a pregnancy test.

MakerHealth started producing the tests in January 2018; Klapperich hopes to have 1,000 of them ready by this summer, when the pilot test at Sri Ramachandra Medical College is set to begin.