Caprion Proteomics aims next year to open a CLIA lab for protein biomarker-based diagnostics, several of which will likely be run on a mass spec platform, a company official told ProteoMonitor this week.
Caprion, which was acquired last week by private equity firm Chicago Growth Partners, has four lead diagnostic programs – tuberculosis, brucellosis, lung cancer, and diabetes.
In the case of tuberculosis and brucellosis, the company plans to convert the protein biomarkers identified for those tests to a standard immunoassay system, making them more easily accessible in point-of-care settings. It intends to run the lung cancer and diabetes diagnostics, however, as laboratory developed tests using multiple-reaction monitoring mass spec, said president and CEO Martin LeBlanc.
Caprion believes that for CLIA-based LDTs, MRM-MS "is ready for prime time," LeBlanc said, adding the he expects that mass spectrometry's potential advantages over immunoassays in matters of cost, throughput, and reproducibility will drive adoption of the technique for protein diagnostics.
"I think we're about to see a generation of [mass spec-based protein diagnostics] come to market, and hopefully Caprion will be part of that," he said.
Mass spectrometry – and MRM-MS, in particular – has for years been cited as a potential platform for protein-based diagnostics. Challenges including throughput, cost, reproducibility, and sensitivity, however, have hindered the technology's move into the clinic (PM 10/22/2010).
LeBlanc suggested, however, that between improved instrumentation, informatics, and sample prep workflows, mass spec is approaching viability as a clinical platform.
"Every year or two, mass spec sensitivity – especially in terms of MRM – goes up by a log," he said. "The ability to multiplex is also going up. And I think on the front end, liquid chromatography reproducibility [is improving] as well. So I think the field is ripe for [moving mass spec into the clinic.]"
Caprion is working on its lung cancer program with Seattle-based protein diagnostics firm Integrated Diagnostics, which, LeBlanc noted, is leading the effort with Caprion to receive milestone and royalty payments for discovery and assay development work it has done for InDi.
In January, InDi announced a collaboration with Agilent on improving existing MRM-MS techniques with the aim of moving its lung cancer test to commercialization (PM 1/13/2012). It said that it aims to bring the diagnostic to market as a laboratory-developed test early next year.
Caprion, LeBlanc said, has "access to the same [MRM-MS] technologies and has developed a lot of the same technologies and reduced to practice a lot of the current technologies that InDi has."
He added that the company is "tweaking, in collaboration with [InDi], certain parts of the assay to try to optimize steps and improve reproducibility."
While InDi is driving the lung cancer work, Caprion is developing its diabetes program entirely in house, LeBlanc said. The company is developing a test that can be used to predict the onset of diabetes as well as measure disease progression and monitor response to treatment. It hopes to finalize the proteins used in the test by the beginning of next year, after which it will work to optimize clinical mass spec workflows for the selected proteins.
The company uses all off-the-shelf instrumentation and has yet to "make any final decision on what the ultimate detection platform is going to be for these CLIA diagnostic tests," LeBlanc said.
He added that thus far the company had primarily been using Waters and Agilent chromatography systems and the AB Sciex QTRAP 5500 and Agilent 6940 triple quadrupole. It also plans this fall to acquire one of the newly released AB Sciex QTRAP 6500 instruments, he said.
LeBlanc noted that while he believes mass spec is primed for clinical proteomics in a CLIA setting, he is less certain the technology is ready to move through the US Food & Drug Administration's regulatory process.
"It might be a little while still until you can do a full [pre-market approval] for diagnostics for regulatory compliance," he said. "I think that will come, but I don't think that's next year."
He added that while Caprion would "definitely be a partner with any instrument manufacturer" that wanted to take its system through the FDA regulatory process, such efforts "will have to be driven by the mass spectrometry instrument manufacturers."
In recent months, several mass spec vendors have moved toward obtaining regulatory clearance for certain of their mass spec platforms, with Agilent registering its Infinity Series 1200 liquid chromatography systems and 6000 Series mass spectrometry systems as Class I medical devices (PM 1/20/2012) and AB Sciex announcing its plans to likewise register some of its mass spec instruments (PM 3/16/2012).
"This is clearly something that is within the sights of these instrument manufacturers," LeBlanc said.
Caprion's mass spec-based diagnostic plans are "core to the strategy we're going to employ under our new ownership," he noted, referring to last week's purchase of the company by CGP, which bought Caprion from healthcare investment firm Great Point Partners and Thallion Pharmaceuticals (GWDN 7/19/2012).
Thallion sold its stake in Caprion for approximately C$4.5 million (US$4.5 million). Additional terms of the sales were not disclosed.
LeBlanc said CGP didn't acquire Caprion with the intention of investing additional capital, but that the company has been profitable now for several years and plans to deploy these profits to support its ongoing programs and enter new markets.
In addition to its traditional focus on protein biomarker and target discovery, Caprion hopes to use recently acquired immuno-monitoring technology and flow cytometry to make inroads into the predictive toxicology and biosimilars markets, LeBlanc said, adding that "proteomics and flow cytometry represent a powerful combination."
Caprion's revenues were in the "mid-teens of millions" in 2011, he said, adding that the company expects revenues in the "high teens" of millions this year and is targeting revenues in "the twenties" of millions in 2013.
Additional reporting for this article was contributed by Tony Fong