Caprion Proteomics said this week that it had entered into a collaboration agreement with Global Genomics Group (G3) to discover and validate protein biomarkers linked to cardiovascular disease.
The deal continues what Caprion CEO Martin LeBlanc characterized as an upswing in demand for the firm's services from diagnostic outfits. He noted that while Caprion continues to pursue the pharmaceutical projects that comprised much of its business over the last decade, recent advances in mass spec-based clinical proteomics have opened up new opportunities in the diagnostics space.
"It's our strategy to continue to work with pharmaceutical companies on biomarker [discovery and validation], but increasingly we have started to work with diagnostic companies, as well," LeBlanc told ProteoMonitor. "We think that mass spec now is suitable for being [used in] clinically validated, regulatory approved diagnostic tests."
Under the G3 agreement, Caprion will identify blood-based protein markers for the ongoing GLOBAL (Genetic Loci and Burden of Atherosclerotic Lesions) study, a multi-center pan-omic study funded by G3 that aims to recruit up to 10,000 patients to characterize disease pathways and biomarkers linked to coronary artery disease.
The GLOBAL study, which G3 is conducting with its strategic partner Health Diagnostic Laboratory, combines genomics, epigenomics, transcriptomics, proteomics, metabolomics, lipidomics, and lipoprotein proteomics with coronary computed tomographic angiography data. Caprion will generate proteomic data for the effort using its CellCarta system, a mass spec-based platform for measuring differences in protein expression between plasma samples.
The company plans to run a discovery experiment numbering in the hundreds of samples, following that up with validation work using thousands of samples, LeBlanc said. That is a relatively large number of samples for a discovery experiment, but within range of Caprion's typical projects, he said, estimating that this stage of the analysis will take roughly six months to complete.
Caprion currently uses Thermo Fisher Scientific's Q Exactive instrument for the bulk of its discovery work. A number of researchers have also explored using the Q Exactive – and other high-resolution mass specs – for targeted protein quantitation, but LeBlanc said that Caprion typically sticks to multiple-reaction monitoring assays on triple quadrupole machines.
"There are certain times when the Q Exactive can help you for targeted analyses, but I would say the majority of our use for it is for non-targeted work," he said. He added that the company has found that MRM assays can provide higher sensitivity than targeted high-res assays. Caprion currently uses Agilent's 6490 triple quad and AB Sciex's 6500 QTRAP for its MRM work.
LaBlanc estimated that the targeted, validation stage of the project would take around a year, depending on the pace of sample recruitment.
Caprion is participating in the GLOBAL study solely as a service provider and will not have rights to any of the IP it generates through the project.
LeBlanc noted, however, that the company is currently pursuing a number of other diagnostic projects in which it has a more significant stake. Caprion has internal programs aimed at developing diagnostics for tuberculosis and diabetes. The company also is building a CLIA lab at its Montreal headquarters out of which it plans to offer some portions of these tests, he said.
"If we think that the ultimate clinical diagnosis can be performed out of a [mass spec-based] proteomics CLIA lab, then there is a good chance we will go all the way" in taking a test to market, LeBlanc said.
If, on the other hand, a test is better suited to an immunoassay format, Caprion will likely seek out a partner to which it will license the test, he said, noting that development of such assays lies outside the firm's area of expertise.
LeBlanc said that "certain dimensions" of both its tuberculosis and diabetes tests could be well suited to a mass spec platform. He did not provide a timeline for their commercialization, but said that the company plans to complete its CLIA lab by the end of this year or early 2015.
In addition to its own internal programs, LeBlanc said Caprion hoped to use its CLIA lab as a commercial platform for other companies' proteomic tests, in-licensing products from firms with mass spec-based diagnostics who don't plan to launch commercially in Canada themselves.
"For companies who have developed [mass spec-based] diagnostics in the US and don't necessarily have intentions of commercializing them in Canada, we can be a credible partner," he said.
While few mass spec-based proteomic tests have come to market to date, LeBlanc said that he believed more and more companies will consider this route in the future. Currently, Sera Prognostics and Applied Proteomics have announced plans to launch mass spec-based tests for preterm birth and colorectal cancer, respectively. LeBlanc added that UK-based diagnostics firm Abcodia has also shown interest in using mass spec for protein-based cancer diagnostics.
Caprion is also a stakeholder in Integrated Diagnostics' Xpresys Lung test, which last year became the first MRM-MS based proteomic diagnostic to make it to market. Caprion, LeBlanc said, receives royalties from sales of the test, which it helped develop and validate.
He suggested that the success of the Xpresys Lung test's development could lead to more companies interested in taking the mass spec route.
"With Integrated Diagnostics it took us four years to go from a hypothesis to a commercial test using mass spectrometry all the way through," he said. "So that showed that it is possible to do on a reasonable timeline."