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Metamark Seeing Rapid Uptake of Promark Proteomic Test for Prostate Cancer

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NEW YORK (GenomeWeb) – Proteomics firm Metamark is seeing strong sales of its Promark prostate cancer test, with nearly 1,000 ordered since the product launched this summer.

The test, which lists for $3,900, measures levels of eight proteins in formalin-fixed, paraffin-embedded prostate biopsies to determine the likelihood that a patient's cancer is aggressive.

Metamark released the test in June in a soft launch targeting around 35 urology practices, then followed that with a nationwide roll-out starting Oct. 1. According to Shawn Marcell, Metamark's president and CEO, the company has sold roughly 700 tests in the two months since the national launch.

Metamark also said this week that its laboratory has received accreditation from the College of American Pathologists. 

The quick uptake is due in significant part to the somewhat unique route Metamark took to building out its sales infrastructure, Marcell suggested. 

In August 2013, the company purchased a urology-focused anatomic pathology business from HealthTronics Laboratory Solutions, a subsidiary of Endo Health Solutions. With this purchase, Metamark acquired the "full commercial infrastructure" required to support the Promark launch 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.

"As soon as Promark became available, we launched it into our existing [urology customer] channel, which led to a very rapid uptake," Marcell said.

As vice president of molecular diagnostics at Sequenom and general manager at Hologic Gen-Probe prior to joining Metamark in 2013, Marcell said that his past experience building out commercial infrastructure for molecular diagnostic companies informed his decision to take a less traditional route with Promark.

"You've seen the model out there where a company has a single biomarker test and they try to build commercial infrastructure for the US and Europe from scratch," he said. "It's an outdated model. The capital requirements are just staggering."

Indeed, over the past decade a number of proteomics firms 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.

"I've done this before," Marcell said. "I built out the commercial infrastructure at a couple of companies, and I just said, 'Look, I'm not doing it this way again.'"

Instead, Metamark looked to the anatomic pathology business with the aim of finding a ready-made infrastructure to support its test launch. And, notes Marcell, it was fortunate in this regard due to low interest in such businesses on the part of acquirers.

"We kind of lucked out because anatomic pathology laboratories were way out of favor as acquisition targets," he said. "Prices were depressed because of reimbursement cuts in rates for biopsies and other tests, and so they were available inexpensively."

"The anatomic pathology business is not a high margin business, but as a strategic platform for a test like Promark and other products in urology, it's a fantastic platform," he added.

He estimated that Metamark was able to acquire the HealthTronics anatomic pathology business for roughly one-fifth what it would have cost to build the equivalent commercial infrastructure from scratch. The acquisition price was not disclosed, but in a report published on Endo earlier this year, Zacks Equity Research noted that HealthTronics' had sold both the pathology business purchased by Metamark and an image-guided radiation therapy business (to another buyer) for a total of $25 million.

In addition to providing the necessary infrastructure for Promark, the pathology business also generates around $20 million annually from traditional pathology services, Marcell said.

Based in Cambridge, Mass., Metamark launched in 2007 with the aim of developing a molecular test for melanoma. That was shelved after several years of unsuccessful efforts, and in 2010 the company began work on the prostate cancer assay that would become Promark.

The company uses off-the-shelf multiplex imaging systems along with proprietary software for both its discovery work and running the final, clinical assay. This summer the company and collaborating researchers published a study in the British Journal of Cancer detailing discovery of an initial 12-marker panel. That panel was later winnowed down to the ultimate eight markers that comprise the Promark test.

The test is intended for use in men with Gleason scores of 3+3 or 3+4 to determine if their prostate cancer is likely aggressive and requires treatment including a possible prostatectomy, or is likely indolent and can receive less aggressive treatment.

According to numbers cited in the BJC paper, 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 the US will undergo aggressive treatment, typically radical prostatectomy. As such, a test for more confidently identifying patients with indolent disease is highly desirable and, indeed, a number of companies, including Genomic Health, Myriad Genetics, GenomeDx, and Opko Health have launched tests for this purposes, while a number of other firms and laboratories are developing similar tests.

According to Marcell, Promark can distinguish between aggressive and indolent disease with 90 percent sensitivity and over 40 percent specificity, which, he said, represents a significant improvement over standard clinical measures.

Metamark is currently involved in four trials for the test – a prospective clinical trial, a retrospective outcomes study, a clinical utility study, and a registry study – and plans to begin seeking coverage for it from Centers for Medicare & Medicaid Services and large private payors at the beginning of next year. 

Additionally, Metamark has in its pipeline proteomic tests for bladder cancer and esophageal cancer and plans to launch the bladder cancer test commercially by the end of 2015, Marcell said.

The company, which has roughly 110 employees, is financed entirely by funds from "high net worth individuals," he noted.

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