NEW YORK (GenomeWeb) – Having consolidated its test development efforts to focus on the urologic oncology market, Belgium's MDx Health is planning to launch at least one new test for bladder cancer this year after releasing its second prostate cancer test, SelectMDx, this spring.
SelectMDx is a urine-based assay that can help stratify patients who have clinical factors that suggest they need a prostate biopsy, such as high PSA levels, into those at higher and lower risk, helping to avoid unnecessary procedures.
MDxHealth President and CEO Jan Groen told GenomeWeb that the company released the new test initially in Europe last fall, and has made it available in the US through its Irvine, California lab as an LDT since March.
Meanwhile, in recent months the company has also reached important milestones for its current flagship test, ConfirmMDx, including recognition by the National Comprehensive Cancer Network (NCCN) in its 2016 guidelines for prostate cancer screening, as well as the publication late last month of a multicenter validation that supports the utility of the test to positively identify men at high risk for aggressive prostate cancer who may benefit most from a repeat biopsy.
Groen told GenomeWeb that the new study supports an expansion from the test's initial indication of a highly specific negative predictor to identify low-risk men who may forego an unnecessary repeat biopsy, to a positive predictor of risk of high-grade disease in negative biopsy cases.
"With approximately 1.3 million biopsies per year, there are about 240,000 newly diagnosed [prostate] cancers in the US," Groen said. "That leaves about 1 million negative biopsies."
With a 96 percent negative predictive value in ruling out high-grade disease, and 90 percent NPV for ruling out any cancer, a negative ConfirmMDx result is a powerful tool for reiterating and supporting a negative biopsy result.
Now the company has also begun to build up evidence for the positive predictive value of the test.
According to Groen, the company has been promoting commercial use of the test since late last year, and has now bolstered these efforts with the publication last month in The Prostate.
In the study, investigators from several European universities, as well as Johns Hopkins University in the US, set out to develop an algorithm for interpreting methylation intensity as read out by ConfirmMDx, and translating it to a risk score. When combined with clinical factors like PSA and histopathology, this score could more accurately predict which men with a negative biopsy have the highest risk of still developing serious prostate cancer.
To develop the algorithm, the researchers used two cohorts representing a total of about 800 men with histopathologically negative first biopsies and a second biopsy that was either positive or negative.
With an AUC of 0.76, they reported that the combined methylation intensity and clinical risk score improved the identification of men with high-grade cancer, resulted in better patient risk stratification, and significantly outperformed current risk prediction models, including both the Prostate Cancer Prevention Trial Risk Calculator, and PSA alone, the authors wrote.
Groen said that MDxHealth is now looking beyond ConfirmMDx, and the newer SelectMDx, to a planned launch later this year of its first test for bladder cancer.
This test, similar to ConfirmMDx for prostate cancer, is designed as negative predictor. In the bladder cancer setting, patients diagnosed with hematuria, or blood in the urine, are traditionally followed with cytology and cystoscopy, which are relatively invasive and are prone to missing small papillary bladder tumors, satellite lesions, or carcinoma in situ.
ConfirmMDx for bladder cancer, which MDxHealth has been building around methylation markers licensed from Erasmus University Medical Center in The Netherlands, is intended to help rule out the presence of cancer, sparing those patients invasive follow-up cystoscopy procedures.
In early experiments in a cohort of 154 patients with hematuria, the company calculated a negative predictive value for the urine-based test of 98.3 percent.
"Most patients with hematuria see a [general practitioner] and are treated with antibiotics, but about one million get a referral to a urologist and we [believe] we can help them by testing for the absences or presence of bladder cancer," Groen said.
Next in line in MDxHealth's pipeline behind the bladder cancer test is a third prostate cancer test in early validation, called InformMDx, which Groen said is a molecular profiling assay that is intended to help better risk-stratify patients who have already been diagnosed with prostate cancer based on histopathological analysis.
Following all these, the company is also pursuing a kidney cancer test. "We've published a few data and have identified the biomarkers we want to work with, but that is still in the research department," Groen said.