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MDxHealth Hopes to Build Lead in Prostate Risk Testing With Utility Evidence for SelectMDx Aug 15, 2018 | Molika Ashfor NEW YORK (GenomeWeb) – MDxHealth continues to build evidence of validity, utility, and cost effectiveness of its SelectMDx prostate cancer risk test, which is intended to help reduce unnecessary imaging and biopsy procedures in men with signs of a possible prostate cancer. The company's most recent publication, which appeared in The Journal of Urology last month, used mathematical modeling to estimate that the use of SelectMDx in men presenting with high PSA levels could resulted in an average gain of 0.045 quality adjusted life years at a cost-savings of $1,694 for each patient undergoing biopsy. The new study joins other cost-effectiveness analyses MDxHealth has conducted for markets outside the US, as well as data presented at recent scientific conferences regarding the impact of the test on physician decision making. MDxHealth President and CEO Jan Groen said that the company is hoping that building evidence for the test's impact on care and then using that information to support health economic analyses can help it persuade additional payors to cover the assay, and in turn drive penetration of what the firm estimates is a large global market. SelectMDx is a urine-based DNA methylation assay that is intended to help stratify patients who have clinical signs of a possible prostate cancer — such as high PSA levels — into those at higher and lower risk, helping to avoid unnecessary follow up. Interest in molecular tools for prostate cancer risk assessment has grown alongside wider recognition of the limitations of existing PSA measurement schemes and resulting overuse of biopsies. Other tests that have been launched so far include Exosome Diagnostics' urine-based test called ExoDx Prostate (IntelliScore), but other companies like OTraces and MiR Scientific have stated their intentions in the space. Though Groen said that MDxHealth doesn't believe that it has significant competition at this time, being able to translate its head start into market penetration would certainly help the company stay ahead of emerging competitors. The firm released SelectMDx initially in Europe, and then in the US starting in March 2016, and test volume has grown significantly, with the firm reporting earlier this year, for example, that its SelectMDx volumes in Q1 were up 62 percent from the same period in 2017. Since its introduction, Groen said that MDxHealth has tested more than 25,000 patients. That said, the company is still far from addressing what it estimates to be a 1.5 million- to 2 million-person annual market in the US, and likely double that worldwide. MDxHealth's tissue-based test, ConfirmMDx, still dominates its sales, representing more than 90 percent of total revenues in Q1 this year. And although it has negotiated 15 contracts with commercial US payors, the firm has not yet sought or received Medicare coverage for the assay. According to Groen though, MDxHealth is hopeful that data from its recent US cost modeling study, as well as growing evidence that the test impacts clinical decision making, will support negotiations with additional US health insurers. "Once you show the test works, you still have to show that doctors are changing their behavior when they get a test result," said Michael Brawer, the company's chief medical officer. Recent presentations by the company at the Global Congress on Prostate Cancer included data from a study of 400 clinical cases, that showed that when physicians used SelectMDx, they went on to send high-risk patients for a biopsy close to five times more frequently than they did patients with a low-risk result. Moreover, Brawer added, the timing of biopsy was dramatically different in the high-risk versus low-risk cohorts. "The majority of patients with a positive test got a biopsy within three months, but it was much later in the ones with a negative test, and most often owing to a significant change in PSA level during the follow up period," he said. A second study presented at the meeting looked at the potential impact of the test on reducing unnecessary MRIs. Groen added that MDxHealth is currently running a health economics analysis for reduced imaging — similar to the recent paper on cost savings in the context of biopsies. In that study, researchers set out to model the cost-effectiveness of SelectMDx in a population of US men with elevated PSA, calculating what the impact would be of utilizing the assay prior to ultrasound-guided prostate biopsy. Researchers modeled the influence of the test in terms of both quality-adjusted life years and in terms of healthcare costs from a Medicare payer perspective specifically. According to the authors, incorporating SelectMDx resulted in an average gain of 0.045 life years at a cost-savings of $1,694 for each patient. And extrapolating these data to an estimate of about 312,000 patients per year undergoing biopsy, the authors wrote that the test could potentially improve patients' health by 14,035 life years with an annual cost saving of more than $500 million per year. The US cost calculations mirror others that MDxHealth has presented for European countries at recent conferences, Groen said. Along with a recent update to the European Association of Urology clinical guidelines, these data should help drive continued growth and adoption of the test in Europe. Based on available evidence, the new guidelines say that biomarker analysis, including the SelectMDx test, "could help in discriminating between aggressive and non-aggressive tumors with an additional value compared to the prognostic parameters currently used by clinicians." In addition to helping to grow test adoption and payment, Groen said that the Journal of Urology study is also a milestone in MDxHealth's longer-term plan to push Select MDx into the primary care market both in and outside the US. In support of that, the company is working on validity studies for the use of the test to inform care for men with lower PSA levels and is looking into the possibility of porting the test to a sample-to-answer platform. Finally, Groen said, MDxHealth is also moving forward with research on the utility of the test as a monitoring tool in men undergoing prostate cancer active surveillance.