NEW YORK(GenomeWeb) – Proteomics firm Caprion said this week that it has signed an agreement to in-license Integrated Diagnostics' Xpresys Lung cancer test.
The agreement gives Caprion exclusive rights to market and commercialize Xpresys Lung in Canada.
Xpresys is intended to aid doctors in identifying lung nodules detected via CT scans as likely benign. The test uses multiple-reaction monitoring mass spec to quantify the levels of 11 proteins in patient blood samples. Indi launched the test in the US in 2013.
Caprion hopes to launch the test sometime this year after completing CLIA certification of its clinical laboratory and securing reimbursement for the test, Caprion CEO Martin LeBlanc told GenomeWeb.
The company will pursue reimbursement in Quebec first, with other provinces to follow he said, noting that underCanada's government-run single-payor system, province health agencies are the key decision makers regarding reimbursement for the test.
The rationale for using Xpresys is that by identifying nodules that are likely benign physicians can more comfortably put patients on a regimen of watchful waiting. A non-invasive test like Xpresys is desirable due to the expense and significant risks of the invasive procedures currently used for determining lung cancer status, like fine needle aspiration and thoracotomies.
Caprion is currently undertaking healthcare economic studies aimed at demonstrating that Canada has an overtreatment problem with regard to benign lung nodules, LeBlanc said, adding that "initial results suggest there is a valuable market" in the country.
Caprion has been generating data to support the launch of a Canadian version of Xpresys through its participation in Quebec's Personalized Medicine Partnership for Cancer initiative, a four-year, C$21 million (US$16.9 million) public-private partnership launched in 2013 and focused on development and implementation of clinical biomarkers and personalized medicine strategies for oncology.
As LeBlanc told GenomeWeb upon launch of the initiative, the company is "leveraging the access [provided by the PMPC] to a broader sample population to conduct further prospective validation of the [Xpresys] test using MRM-MS and ultimately generate real-world data in the Quebec healthcare system to help justify commercialization and reimbursement in Quebec."
LeBlanc noted this week that in the event the company secures reimbursement for the test before its CLIA lab is complete, it has arranged to run tests out of Indi's Seattle-based CLIA facility.
The license agreement is part of Caprion's larger strategy to use its mass spec expertise to position itself as a Canadian partner for firms looking to offer clinical diagnostics in the country.
Indeed, Caprion played a key role in the development of Xpresys, collaborating with Indi on a significant portion of the biomarker discovery and validation work underlying the test.
The company is also developing its own in-house diagnostics, with its first planned offering a proteomic test for predicting the onset of diabetes as well as measuring disease progression and monitoring response to treatment.
In addition to diabetes, Caprion is also developing proteomic tests for tuberculosis and brucellosis. It is also working with diagnostics firm Abcodia and Cancer Research UK on mass spec-based discovery and validation of serum-based protein biomarkers for colorectal, lung, esophageal, and pancreatic cancers.
The majority of the company's planned tests are based on multiple-reaction monitoring mass spec, which Caprion has played a leading role in pushing towards the clinic as a tool for targeted proteomics. Xpresys is the first multiplexed proteomic test to go to market using MRM-MS.
Under the agreement, Caprion will pay Indi royalties on revenues generated by the test and several milestone payments tied to events like positive reimbursement decisions.
LeBlanc suggested that Caprion's experience launching the test in Canada could also inform Indi's efforts to expand into other countries with similar healthcare systems.
"The experience of Canada might help Indi in understanding how to go to market in other jurisdictions like Europe where the healthcare systems tend to resemble the Canadian one more than the US system," he said.