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Study Finds Metamark's Prostate Cancer Test Offers Benefits Beyond Current Standards of Care

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NEW YORK (GenomeWeb) – Researchers from the Fred Hutchinson Cancer Research Center have published a health economic analysis of Metamark's Promark prostate cancer test that found the test offers an increase in quality-adjusted life-years (QALY) and a decrease in costs to the healthcare system compared to the current standard of care.

Detailed in a paper published this week in The Oncologist, the study found that addition of the Promark to existing National Comprehensive Cancer Network treatment guidelines for prostate cancer provided a .04 increase in QALY (from 14.62 to 14.66 years) while reducing lifetime treatment costs $730 (from $32,595 to $31,865).

The study also found that addition of the test to the NCCN guidelines resulted in a decrease in overall life-years (from 18.37 to 18.43). However, noted the authors (who are consultants for Metamark), QALY is "considered the gold standard metric in cost-effectiveness analyses."

The cost savings and QALY improvements stem from the test's utility in distinguishing between prostate cancer patients with low- and high-risk disease, thereby allowing doctors to avoid the over-treatment that has proved an issue for the field, said Jerome Richie, Metamark's chief medical officer and the former head of urology at Boston's Brigham and Women's Hospital.

Only one in seven men diagnosed with prostate cancer will progress to metastatic disease over their lifetime. However, roughly 90 percent of low-risk prostate cancer patients in theUSwill undergo aggressive treatment, typically radical prostatectomy.

This treatment pattern is changing, however, as more urologists are opting for active surveillance as opposed to treatment, Richie told GenomeWeb. He cited a letter by University of California, San Francisco researchers Matthew Cooperberg and Peter Carroll published this summer in the Journal of the American Medical Association that noted that in recent years the percentage of low-risk prostate cancer patients being put on active surveillance as opposed to aggressive treatment has risen from around 10 to 40 percent. 

Tests like Promark, Richie suggested, can play a role in furthering this trend by providing a tool to increase doctors' confidence that patients are, indeed, good candidates for such an approach.

Intended for use in men with Gleason scores of 3+3 or 3+4, Promark measures the levels of eight proteins in formalin-fixed, paraffin-embedded prostate biopsies to determine the likelihood that a patient's cancer is aggressive.

In the Oncologist study, the researchers used a combination of data from Metamark's retrospective validation study of the test and UCSF's Cancer of the Prostate Strategic Urologic Research Endeavor, which has evaluated prostate cancer treatments in roughly 12,000 men across theUS.

Using Markov modeling the researchers simulated health outcomes for a cohort of patients 60 years of age with biopsy Gleason scores of 3+3 or 3+4, comparing the results of treatment according the NCCN guidelines alone with the NCCN guidelines plus Promark with regard to life-years, QALY, and medical costs.

In 87 percent of the simulations, the model found that the NCCN guideline plus Promark yielded better results. Richie further suggested that study findings might, in fact, be somewhat conservative, given that the researchers used what he said was a conservative figure for the percentage of patients receiving active surveillance.

The study model assumed that "instead of 90 percent of patients getting aggressive treatment, 75 percent of patients would get aggressive treatment," Richie said, noting that this was "probably an underestimate of what is happening in the world."

The Oncologist study is just one of several Metamark has ongoing to bolster the scientific and economic cases for Promark. Most prominently, the company is collaborating with researchers at Johns Hopkins on a prospective validation study, data from which will likely be available in the next three to four years, Richie said.

Additionally, the company has in collaboration with Stanford University researchers completed a clinical vignette study looking at how the test changes doctors' treatment decisions. Currently submitted for publication, the study found that physicians using Promark changed their recommendations to active surveillance in roughly 30 percent of patients.

The company's initial validation study found that Promark could distinguish between low- and high-risk cancers with an area under the curve of .69. This rose to .75 when the test was combined with the NCCN guidelines, which alone have an ROC of around .67, Richie said.

He added that in patients with Gleason scores of 3+3 the test returned an actionable result around 80 percent of the time, with 35 to 40 percent of tests indicating patients were low risk, 25 indicating that patients were high risk, and around 20 percent of test results coming back as indeterminate.

Promark launched sales of the test, which it offers out of its CLIA lab at a list price of $3,800, in the summer of 2014. As of the end of 2014 it had sold roughly 1,000 tests. Richie cited around 500 tests performed in 2015, but a company spokesperson said this number was more representative of the number of tests performed as part of clinical trials than the company's overall test volume. The company declined to say how many Promark tests it has sold this year, but said that sales had grown 200 percent between Q1 and Q2.

The company took a somewhat unique path to commercialization, purchasing in 2013 a urology-focused anatomic pathology business from HealthTronics Laboratory Solutions, a subsidiary of Endo Health Solutions, which provided it with much of the commercial infrastructure needed to launch the test, including reimbursement specialists, a billing and collections department, laboratory facilities, a national sales force, and a customer base of roughly 500 US urology practices comprising some 2,500 urologists.

This approach stands in contrast to that of many other proteomics companies that, over the past decade, have run into difficulties after pushing their tests through clinical validation and, in some cases, regulatory clearance, only to discover that tens of millions of dollars more were required to drive adoption in the marketplace.

Metamark is currently working to secure reimbursement for Promark from the Centers for Medicare & Medicaid Services and large private payors. In April, the company said it had signed an agreement with Highmark Blue Shield that provides coverage of the test to 5.2 million people in Delaware, Pennsylvania, and West Virginia.

In September, Metamark announced it had obtained $10 million in financing to support commercialization of Promark as well as development of other urological assays.

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