Gregor Diagnostics has raised $900,000 from investors as part of a seed funding round that the Madison, WI-based startup says will support its efforts to develop a new, at-home screening test for prostate cancer that it hopes will offer a more precise alternative to the current testing standard for the disease.
San Francisco-based First Round Capital and Dallas-based Green Park & Golf Ventures led the round, according to a news release. Other investors included the Wisconsin Alumni Research Foundation, Flatiron Health co-founders Nat Turner and Zach Weinberg, and Health Wildcatters, a startup accelerator in Dallas that Gregor graduated from in late 2017.
Prostate cancer is the second deadliest cancer among American men, trailing only lung cancer, according to the American Cancer Society. The organization estimates that 29,430 men in the U.S. will die from prostate cancer in 2018.
What also troubles Zutz and some other prostate cancer researchers is that today, many men are not getting screened for the disease. The percentage of American 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. (Those declines have abated somewhat in the years since, according to the organization; in April 2017, it said screening rates had, over the previous 12 months, “remained stable at 32.1 percent.”)
“We are missing aggressive prostate cancers where early detection can save lives,” Zutz says in Tuesday’s news release.
Performing a blood-based, prostate-specific antigen (PSA) test—which measures levels of a protein produced by cells in the prostate gland—is currently the most common method to screen for prostate cancer, according to the Memorial Sloan Kettering Cancer Center. The organization says on its website that there’s “clear evidence that screening with a [PSA] test can reduce the number of deaths from prostate cancer.”
However, Zutz says the PSA test tends to pick up not only aggressive forms of prostate cancer, but also slow-developing, “indolent” cancers, which he says are much less likely to harm patients. Picking up indolent cancers leads to lots of false positive test results at the screening stage, he says.
To address this problem, Gregor is seeking to bring to market a diagnostic that’s more precise than a PSA test. If that comes to pass, the result could be fewer men needing to undergo biopsies and other invasive procedures, Zutz says.
“Diagnostics can play an outsized role in patient and population health, as they can have an extreme impact on curbing the use of unnecessary and expensive treatments and procedures,” says Josh Kopelman, a partner at First Round Capital.
Zutz says Gregor wants to improve on the status quo in prostate cancer screening by “trying to tackle this problem from both angles: by decreasing over-diagnosis and over-treatment, while enabling more effective detection of aggressive prostate cancer.”
The startup’s test would screen for prostate cancer using samples of seminal fluid, rather than blood, Zutz says. Gregor believes it’s better to test seminal fluid because the prostate produces about 30 percent of the fluid, which means it has more access to the biomarkers indicative of prostate cancer. Testing for these biomarkers in seminal fluid could turn up signs of prostate cancer that would be undetectable in blood or urine at the same stage of the cancer’s development, the company says.
Gregor faces a commercialization pathway that could span many years and cost tens of millions of dollars. Later this year, the startup plans to kick off a study evaluating a panel of biomarkers that Gregor’s team believes can distinguish between healthy and cancerous cells in semen samples, Zutz says. If that study goes according to plan, Gregor would likely conduct two additional studies, followed by a pivotal FDA clinical study involving thousands of patients, he says.
But Gregor is taking things one step at a time, and is for now focusing on the upcoming marker panel study.
“This financing will allow Gregor to demonstrate the efficacy of our test in a set of patient samples,” Zutz says.