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Contextual Genomics to Beta Test Affordable Cancer Panel for Personalizing Cancer Therapy in Canada

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Originally published August 8.

NEW YORK (GenomeWeb) – Vancouver-based molecular testing firm Contextual Genomics is hoping in the next six months to launch a beta version of a multi-marker genomics panel that it hopes will be an affordable option for healthcare providers and payors in Canada looking to personalize treatment for cancer patients.

Contextual Genomics recently announced its plans to launch the so-called National Access Project in collaboration with the Personalized Medicine Initiative, an organization of stakeholders interested in bringing precision care to Canada. The company has developed a next-generation sequencing diagnostic panel that gauges 90 somatic cancer mutations associated with responses to currently marketed drugs for solid tumors and investigational agents in late-stage trials.

"What we see from that research will go into altering the actual test that's being offered," Contextual Genomics CEO Chris Wagner recently told PGx Reporter. Through the National Access Project, the firm is planning to test for free 2,000 Canadian cancer patients and provide the results to the treating physician. "It's a product improvement strategy if you will," he noted.

Contextual Genomics is developing its test on Illumina's MiSeq platform. Beta testing the diagnostic, as well as testing patients through the National Access Project, will begin in the first quarter of 2015. "At the end of the beta test, we will assess what the performance was of the instrumentation and we will go from there," Wagner said, noting that Contextual Genomics might decide at that point to move to larger capacity instrumentation.

In developing the panel to date, Contextual Genomics decided on the 90 mutations by drawing from published literature, from FDA-approved drug labels, and from talking to pharmaceutical companies about the specific targeted drugs they market and are developing. "We asked them to look at the list of markers from our desk research and tell us what's missing," Wagner said. "We wanted to make sure that this test can not only be used to direct treatment to existing drugs but that it can also triage [patients] to a clinical trial if there happens to be one associated with their mutation."

Wagner noted that Contextual Genomics has garnered input on the panel from 11 pharma companies, some of which are putting forth money for further development of the test. However, he wouldn't name the drug developers, noting that the company plans to issue a formal announcement in the near future.

Contextual Genomics is developing the test, keeping foremost in mind the challenges for the physician looking to incorporate genomic information in the care of their cancer patients. Most physicians lack training in genomics or pharmacogenomics. Moreover, doctors lack the time to sift through the literature and decide which markers are actionable. "They need something that is very simple and useable to help them in the diagnostic work up of their patients," said Wagner.

The company is also working on making the test report easily understandable by the physician. "We're building Hondas, not Bentleys," Wagner acknowledged. "This test won't please the academic researcher. This test will be designed for the 80 percent of the oncologists out there treating patients every day."

Currently, the majority of oncologists in Canada, as in other countries, that are ordering genomic testing for cancer patients are doing so in a piecemeal fashion, looking initially into common mutations for a particular cancer, and if that doesn't yield answers then moving on to rarer markers. "What we're trying to do is make it so you really have to do one test," Wagner said. "We're trying to make this test the same price as a single test … and make it reimbursable."

The coverage of genomic tests in Canada is determined by regional provinces, and this means that while some patients in a geographic area have access to certain diagnostics, others living in a different area may not receive those same tests. "Every province guides its own healthcare spending and reimbursement," Wagner said.

Contextual Genomics decided to launch the National Access Project after talking to physicians and hearing that all over the world many of them were having trouble getting consistent access to genomic testing. Pharmaceutical firms the company talked to expressed the same concerns.

Moreover, tests that are available nationally through some commercial labs are often too expensive, according to Wagner. "These tests are priced way outside of the level that people are willing to pay," he said, highlighting the high price tag for Foundation Medicine's FoundationOne NGS-based test.

The list price for FoundationOne is $5,800, and Foundation Medicine said recently that its average reimbursement from commercial payors is around $3,400. In the first quarter of this year, the company reported that the sales of its tests drove a 121 percent growth in year-over-year revenues to $11.5 million.

However, reimbursement is still a challenge, as Foundation Medicine does not have a national coverage agreement with Medicare in the US. During an earnings call in May to discuss first quarter financials, Foundation's Senior VP of Finance Jason Ryan said that "consistent with our expectations, we have not yet received payment on [Medicare] claims, given that we're not yet covered by Medicare." He added that the firm is "appealing those claims through the normal channels" as well as continuing "broader dialog with our local Medicare administrative contractor and with other regional contractors."

In an effort to limit the reimbursement challenges molecular diagnostics firms are facing around the world, Contextual Genomics is targeting a below $1,000 price tag for its test. "If we can make a test that serves the average oncologist, give them what they need, priced at a level that's reimbursable, we'll be able to achieve economies of scale that are not possible at regional labs and haven't been achieved by commercial labs."

Contextual Genomics has been in discussions with several provinces in Canada about the benefits of having consistent access to an affordable genomic cancer panel. According to Wagner, payors the company has spoken to so far are supportive of such an idea. "They believe in … improving cancer care to save tax payers money, and [they see] that the inefficiencies in the current system make things more expensive," he noted. "Economically, it's impossible to have a testing facility that tests a small geography be as efficient as a lab that tests all geographies. So, they might wind up paying more for these tests than they have to."

In addition to receiving funding from pharmaceutical companies, some regional provinces are also contributing money for the National Access Project and the development of the test. Contextual Genomics is putting up some of its own money and has received federal grant funding for the effort. Once the test is developed and commercialized, Contextual Genomics has inked a distribution deal with Life Labs.

Eventually, Contextual Genomics plans to offer the test in markets outside of Canada. For the moment, the National Access Project will not look at whether testing patients with the NGS panel improves patient outcomes and survival, but Contextual Genomics will partner with research groups in the future to gather this data. While the lack of this outcomes data won't necessarily hinder adoption by payors in Canada, Wagner said, in the long term, this information will be important in order for Contextual Genomics to compete with other molecular diagnostics firms providing similar tests.

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