Mike Sussman & Melanie Ivancic: Blood work

Madison, Wisconsin, may have become ground zero in the war against one of the deadliest cancers on the planet. Local biotech company Exact Sciences made headlines in 2014 when it received FDA approval for a potentially transformative screening test for colorectal cancer. The noninvasive stool-based test, called Cologuard, just may be the best of its kind. This past June the company made news again when Cologuard received a thumbs up from a governmental task force that evaluates and recommends screening tests for detecting hidden disease. In a lab a few miles away, UW biochemistry professor Mike Sussman likes what he sees. Sussman, along with postdoctoral researcher Melanie Ivancic, is busy taking a different and likely complementary approach. Support from the Accelerator Program is helping their team develop a blood test for predicting colon cancer early and effectively. They recently achieved a major milestone – this summer they doubled the size of their pilot study and successfully collected serum samples from almost 300 patients.
Photo of Melanie Ivancic and Mike Sussman at the 2015 WARF Innovation Awards ceremony

Ivancic (center) and Sussman (right) at the 2015 WARF Innovation Awards ceremony, where they won top honors. Photo: Joe Koshollek

“What makes our test significant is that it is looking at the final product (protein) and not the blueprint (DNA),” says Ivancic. “The test is done in blood rather than stool, which is likely to increase the compliance rate of testing.” They plan to analyze each sample using mass spectrometry, searching for a small set of protein biomarkers they believe indicate pre-cancer or cancer. Preclinical results suggest their test could detect the disease at an early stage and may outperform or complement other diagnostic methods, including Cologuard.

The need is real. Colon cancer claims more than 600,000 lives worldwide every year. When detected early the five-year survival rate exceeds 90 percent but, tragically, about one-third of patients are not up to date on their screening. In part this is because colonoscopy is seen as invasive and inaccessible in many areas. “Colonoscopy remains the gold standard but it’s not perfect,” says Ivancic. “It requires anesthesia, there are some risks associated with perforation, it’s expensive and compliance is low.” Her team is not trying to replace the procedure. Rather, they envision their test as an inexpensive and easy first line of defense. Imagine it – a routine blood draw at the doctor’s office that gets more people screened than ever before, and identifies those at risk to undergo further testing. The dream, of course, is premature. Immune to hype, Sussman and Ivancic are seasoned investigators committed to research as it should be. That means honest data, unimpeachable methods and a healthy perspective. “This is not a slam dunk,” says Sussman, recognizing that mass spectrometry is a complex tool for mainstream blood work. Still, his excitement breaks through. “Melanie is not only detecting proteins but specific parts of proteins,” he says. “We went from thousands of possibilities to these few that we know are changing.” Given their early success, the team now finds itself wrestling with research questions of a different nature. “How would we manufacture this product? How do we do it on a large patient scale? Right now in the academic setting we don’t have the capabilities of running millions of samples,” says Ivancic. “How do we practically move this project forward?” For help answering some of these questions the team applied and was recently admitted into the Discovery to Product (D2P) Igniter program on campus. Ivancic says D2P’s expert mentors are working with them to assess several market-entry strategies. She says that being in the two programs simultaneously – Accelerator and D2P – has been a great complement, helping them refine their technology while getting smart on business. It’s a long road on both fronts. But for Ivancic (“the heart and soul and brains and hands of this project,” in Sussman’s words), inspiration is personal. “Of course the basic science is fun but in the end I’m driven by how this could help people,” she says. “That’s why I’m so invested in this project.”