accurately detect cancer, but also differentiate indolent from aggressive cancer at the screening stage.” Replacing the screening PSA with a 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 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.
