NEW YORK – About a year after its founding, Vesica Health is gearing up to launch a bladder cancer detection test initially developed by MDxHealth that is intended to aid interventional decision-making for patients presenting with hematuria, or blood in the urine. Hematuria can be a sign of a range of conditions, including bladder cancer.
The company licensed its urine-based assay, called AssureDx, from diagnostics firm MDxHealth, which had largely benched the test in recent years to instead focus on its prostate cancer test portfolio.
"I was actually one of the employees that helped work on a lot of the development and launch operations while at MDxHealth, so I've actually spent a fair amount of time over the years working on this particular test," Christopher Thibodeau, the new firm's CEO said this week, noting that he left MDxHealth in 2018.
"There's still a long shelf life in terms of the IP for the biomarkers in the test. And given the clinical validation has been for the most part completed, it's a commercial-ready assay," he added.
Vesica is currently working on completing a fundraising seed round to get its laboratory operations off the ground, aiming to launch in the near term, ideally within a few months.
Thibodeau said the firm is buoyed not only by legacy clinical validation data that speaks to the AssureDx assay's accuracy in predicting bladder cancer risk but also by newer data published earlier this year on the test's clinical impact when used alongside standard risk categorization outlined by the American Urological Association.
In European Urology Oncology in April, researchers led by UT Southwestern Medical Center urologist Yair Lotan examined AUA risk stratification based on sex, age, and type of hematuria in 838 patients from a prior study who were also tested with the AssureDx test, a PCR assay that detects mutations in the FGFR3, TERT, and HRAS genes, and methylation status of the OTX1, ONECUT2, and TWIST1 genes.
According to Vesica, the AssureDx test conferred a statistically significant improvement in the identification of patients at increased risk for bladder cancer over AUA measures alone. Notably, in patients with microhematuria, the assay showed an area under the receiver operating curve of 0.97, with a positive test result resulting in a fivefold increase in the risk of harboring bladder cancer compared to the current risk assessment metrics alone.
Depending on the AUA risk group evaluated, a negative urine assay was associated with post-test cancer probability of 0.3 percent to 2 percent, while a positive urine assay was associated with cancer probability between 31 percent and 42 percent.
The authors wrote that the data offers a justification "to safely withhold cystoscopy for patients with AUA low risk who have a negative urine assay. In addition, evaluation should be expedited for patients with AUA intermediate or high risk and a positive urine assay."
Gerald Andriole, former professor in the department of urology and current director of the Brady Urological Institute in the National Capital Region of Johns Hopkins University, echoed the potential clinical impact for those with positive results. "Primary care physicians are often uncertain how to manage patients with hematuria and, as a consequence, too frequently disease has progressed to later stages by the time the patient is referred to the urology clinic for evaluation," he said.
Thibodeau said that the company's plan is to launch initially as a lab-developed test in the US, but future plans include discussions with the Food and Drug Administration about pursuing clearance of a kit version and pursuing a CE-IVD regulatory path forward in Europe.
In the US, Vesica faces competition on the AssureDx test from Abbott Diagnostics' UroVysion assay, which uses fluorescence in situ hybridization to detect certain chromosomal aneuploidies, and Pacific Edge's mRNA-based Cxbladder.
Thibodeau said he knows the Pacific Edge team well and that he believes the firm's growing market success bodes well for adoption of bladder cancer triage tests across the board.
"Their test provides great clinical utility, so I applaud them and what they're doing. We do believe that our test has broader and more extensive clinical validation based on the studies that have been conducted, and we've got, I would argue, probably best-in-class performance in terms of the overall sensitivity, specificity, or the area under the curve for the assay," Thibodeau said. Vesica reports a 99 percent negative predictive value, 96 percent sensitivity, and 83 percent specificity for AssureDx.
That said, he added, "I think it's such a large unmet need that there could be multiple different diagnostic companies that succeed in this area and really improve patient outcomes."
As a small startup, Thibodeau said Vesica is focused near term on completing its seed fundraising and getting the AssureDx test on the market. However, there are a few other areas the firm is exploring with the six biomarkers included in the current assay.
"There have been several studies on evaluating patients that have been previously treated for early-stage bladder cancer, and we think this could be a great assay for noninvasive monitoring of previously treated patients, to catch disease recurrence early," he said. The team is aiming to complete a final large clinical validation study in that vein within the next two years.
Another potential niche would be for patients who have presented with hematuria and are at risk for bladder cancer, and who undergo cystoscopy but cancer is not detected. Because this does not rule out the presence of bladder cancer or urothelial carcinoma, these patients are often referred to a CT scan to rule out upper-tract disease.
"We have good evidence from studies that demonstrate that our test is highly sensitive for upper-tract disease, up in the ureters above the bladder," Thibodeau said. "That's another indication where we feel that we could really provide added utility to help triage patients and avoid a lot of unnecessary CT scans, which I think is a big, big dilemma in urology."