When Tobias Zutz left his job as a senior research associate at Exact Sciences in 2015, he knew he wanted his next career stop to be at a smaller organization.
Zutz worked at Madison, WI-based Exact (NASDAQ: EXAS), which has commercialized a stool-based DNA test for colorectal cancer, for more than five years. During his time at the company, Exact added hundreds of employees and had its flagship test, Cologuard, approved by the FDA.
But Zutz ultimately decided to strike out on his own, and last year formed Gregor Diagnostics, a Madison-based startup seeking to commercialize a new, at-home test to screen for prostate cancer.
“I love working in these small environments where you contribute to the success [of the organization] at much higher rate,” says Zutz, Gregor’s founder and CEO.
Zutz will spend the next 12 weeks in Dallas participating in the Health Wildcatters startup accelerator, which kicked off on Wednesday. He says he’s looking forward to working with the accelerator’s staff, which includes several physicians, as Gregor continues to plot its fundraising and regulatory strategies.
The latest Health Wildcatters class comprises nine healthcare-focused startups from across the country. Each participating company receives a $30,000 investment in exchange for an 8 percent equity stake, as well as mentorship, office space, and other resources. The program will culminate on Nov. 8 with a pitch event at the Majestic Theatre in downtown Dallas.
Past participants in Health Wildcatters, which launched in 2013, include startups in medical imaging, digital health, telemedicine, and other sectors.
Zutz says that in the months following his departure from Exact, he began looking for early-stage biotech business opportunities in Wisconsin and other states. He met with a licensing manager at the Wisconsin Alumni Research Foundation, the tech transfer office of the University of Wisconsin-Madison. Zutz subsequently learned about research by David Jarrard, a urology professor at UW-Madison’s medical school who had identified several biomarkers for detecting prostate cancer from samples of seminal fluid.
“That got me looking at prostate cancer,” Zutz recalls. “I noticed that screening rates are declining. We’re just not catching people.”
Indeed, the percentage of U.S. men ages 50 and older screened for prostate cancer declined to 30.8 in 2013 from 37.8 in 2010, according to the American Cancer Society. It is the third deadliest cancer among American men; there will be an estimated 26,730 deaths from prostate cancer this year, the organization predicts.
In 1994, a screening test capable of measuring men’s prostate-specific antigen (PSA) levels was introduced for the first time. Zutz says that at the time, the blood-based test was viewed as a major improvement in screening for the disease. However, the test also picked up slow-developing (or “indolent”) cancers that had a low likelihood of harming patients. Picking up those cancers leads to a lot of false positive test results.
“It is an effective screening method for decreasing mortality,” Zutz says of the PSA test. “The problem with it is that you also end up treating a bunch of these indolent cancers that might not cause any problems for the patient.”
The sentiment among middle-aged and older men about getting screened has gone up and down in the decades since the test was introduced, Zutz says. That’s because some men are hesitant to get screened because of what he describes as an “overtreatment problem”: surgeries and other procedures come with risks, but in some cases, little benefit.
Zutz says Gregor’s test is aimed at replacing the PSA test, “to be able to more accurately detect cancer, but also differentiate indolent from aggressive cancer at the screening stage.” Replacing the screening PSA with more precise test could result in fewer men undergoing biopsies and imaging procedures, he says.
Gregor is working with the Wisconsin Alumni Research Foundation to acquire the option to license some of the biomarkers Jarrard identified, Zutz says. Jarrard and other researchers he was working with identified them as part of an effort to find a marker that can reliably distinguish between healthy and cancerous cells, according to UW-Madison.
Zutz says that screening for prostate cancer using seminal fluid samples—rather than blood, for instance—would allow clinicians to “go right to the organ that you’re trying to screen for.”
“You get direct access,” he says. “Whereas with blood, you have to have some kind of breakdown” in which PSAs enter the bloodstream.
The idea is somewhat similar to how Exact Sciences’ screening test for colorectal cancer involves having patients mail samples of their stool to the company’s lab, Zutz says.
Gregor faces a long and likely costly road to bring its test to the market. Zutz says that next year, his company plans to start a study of a marker panel in seminal fluid. If that goes as planned, the startup would likely hold two additional studies (one aimed at making sure the biomarkers in seminal samples remain stable as they’re collected and shipped for testing, the other to determine how different biomarkers are interpreted together to provide a single test result) before a pivotal FDA study, which Zutz says would likely involve thousands of patients.
(Zutz says Gregor could try to commercialize its test as a laboratory-developed diagnostic test, a category of tests that use an FDA regulatory exception that allows companies to market tests that they design and carry out in-house. Such tests bypass a more rigorous FDA review process. Zutz says that for now, his startup is leaning toward going the FDA route.)
Gregor is seeking to close a $1.5 million seed funding round in early 2018, Zutz says. The company would need to raise more money as it makes progress, he says.
The startup’s team is made up of Zutz, Jarrard (who serves as a consultant), acting chief financial officer Greg Hill, and two scientific advisors.
Exact Sciences, which was founded in 1995 by a small team, now has a market cap exceeding $4.6 billion. Zutz and his team of course have a ways to go to match that kind of success, but they view participation in Health Wildcatters as a step in the process of turning their vision into a reality.