NEW YORK (GenomeWeb) – MDx Health has launched its planned bladder cancer test, a liquid biopsy assay that analyzes methylation in three genes — TWIST1, ONECUT2, and OTX1 — along with mutations in three others.
Like the firm's existing prostate cancer test, ConfirmMDx, the new AssureMDx bladder test is designed to help physicians pick out patients who have a low-risk of having cancer and thus can avoid more invasive tests.
In the bladder cancer setting, patients diagnosed with hematuria, or blood in the urine, are traditionally followed with cystoscopy, which can be relatively invasive, not to mention prone to missing certain cancers.
The company estimates that less than a third of individuals who show up to their doctor with hematuria go on to be diagnosed with bladder cancer, suggesting that two thirds are receiving diagnostic procedures that are unnecessary. MDxHealth's test is intended to help rule out the presence of cancer non-invasively, sparing those patients who test negative from cystoscopies.
According to a multicenter validation of the test published earlier this year, the new assay boasts a 99 percent negative predictive value (NPV).
More specifically, assuming a bladder cancer prevalence rate of about five percent in patients with hematuria, the test generated a 99.2 percent NPV. Combined with other clinical measures like cytology, this NPV could increase up to 99.9 percent, the company has suggested.
In addition to this primary rule-out function, results from the company's validation efforts also indicate that positive test results could help inform clinical decisions.
Results of the same study demonstrated a 93 percent sensitivity and 85 percent specificity, suggesting that not only does a negative result indicate an extremely low risk of cancer, but a positive result also marks patients at increased risk for bladder cancer, adding weight to the decision to undergo a cystoscopy.
MDxHealth CEO Jan Groen said this week that the company is hoping that persuading clinicians of the value of the assay will be a smooth process, driven by what is now an experienced sales force with solid client relationships in the urology community forged through sales of its ConfirmMDx prostate cancer test launched in 2012, and its newer SelectMDx liquid biopsy test launched last year.
If anything, the bladder cancer test offers an even stronger clinical rationale than the company's previous assays with its reported 99 percent NPV, Groen argued.
While the firm's ConfirmMDx test for prostate cancer has a slightly lower 96 percent negative predictive value, MDxHealth has been seeing increased adoption and growing acceptance by payors and managed healthcare organizations in the US for this product.
For example, the company said in February that it had been awarded a US General Services Administration contract to supply the ConfirmMDx prostate cancer test to the Department of Veterans Affairs.
ConfirmMDx also recently gained coverage by a variety of Blue Cross Blue Shield affiliates, including Horizon BCBS in New Jersey, Independence Blue Cross, and Highmark BCBS, as well as private payors such as Cigna and Priority Health. In September 2016, the test also received in-network status for the California Medical Assistance Program.
Meanwhile, revenues for the company in the first quarter of the year more than doubled compared to the same period in 2016.
Across the molecular testing space, some companies have struggled to demonstrate the clinical value of their tests to physicians and the economic value to payors. But by targeting its tests to specific clinical niches or decision points, MDxHealth has set itself up to make a case to doctors of how its test could improve their practice, and in turn, to demonstrate a definitive health economic impact to insurers.
MDx Health estimates that about 11 million patients in the US are referred to a urologist every year due to blood in their urine. Based on the high NPV in the firm's validation study, investigators reported that the test could potentially spare as many as 77 percent of hematuria patients from undergoing a cystoscopy.
The company has estimated a combined $3 billion market opportunity in the US for its two prostate cancer tests plus the new bladder cancer test.
Groen said that apart from demonstrating clinical validity and utility, and making a case for health economics, insurers also want to see that a test is actually being used.
"At the end of the day, you can generate a lot of publications, but the last question [payors] ask is, 'What is the utility – how many physicians are ordering it,'" Groen said.
MDxHealth said earlier this year that it tested nearly 24,000 patients worldwide across its two existing prostate cancer tests in 2016. Groen added this week that the company deals with about 4,000 urologists in the US through its prostate cancer testing business.
These same urologists are now customers for the AssureMDx bladder cancer test, and evidence from the scientific literature suggests that they are not unaware of the current limitations and overuse of cystoscopy.
For example, a study published in Urology this February by a team from Emory University concluded that there appears to be "considerable misallocation of cystoscopy for hematuria patients, with excessive use among low-risk patients and significant potential for missed cancer cases among those at higher risk of malignancy."
"We estimated that there are over 20,000 missed cancer cases annually among moderate- and high-risk hematuria patients, and nearly 230,000 excess cystoscopy cases annually for patients with near-zero cancer risk," the authors wrote.
Next in line in MDxHealth's pipeline behind the bladder cancer test is a third prostate cancer test in early validation, called InformMDx, which is intended to help risk-stratify patients who have already been diagnosed with prostate cancer.
The company is also working on a second liquid biopsy test for prostate cancer, but for a different clinical niche – the monitoring of patients after prostatectomy.