Agilent Technologies and Integrated Diagnostics said this week that they have entered a strategic partnership to develop mass spec workflows for protein biomarker diagnostics.
The two companies will partner on improving existing multiple-reaction monitoring mass spec techniques with the aim of moving Integrated’s proteomic tests for lung cancer and Alzheimer’s disease into the clinic.
As part of the deal, Integrated purchased two Agilent 1290 Infinity UHPLC systems, two 6490 iFunnel triple quadrupole mass specs, and two 1260 LCs with ultraviolet detectors. Additional terms of the agreement were not disclosed.
For Agilent, the partnership is further sign of its ambitions to push mass spec-based proteomics into the clinical space and its commitment to doing so using triple-quad-based MRM-MS methods. The company’s 6490 iFunnel is one of the leading triple quad machines on the market, and through a series of recent acquisitions it has surrounded the instrument with sample prep and separations technologies that could enhance its utility as a clinical proteomics platform.
Agilent has also recently taken regulatory steps indicative of its clinical ambitions, obtaining ISO 13485 quality-management status for its LC manufacturing plant in Waldbronn, Germany, and its MS manufacturing plant in Singapore, as well as registering its reagent manufacturing facility in Cedar Creek, Texas, as a medical device establishment with the US Food and Drug Administration.
With the Integrated partnership, Agilent intends to apply these efforts to building a truly commercial clinical mass spec workflow, Gustavo Salem, vice president and general manager of the company’s Biological Systems Division in the Life Sciences Group, told ProteoMonitor.
Mass spec-based protein biomarker work has typically “been a research discussion,” Salem said. “For Integrated Diagnostics, [the issue] is how do we prepare a truly operational, high-throughput CLIA laboratory? So they’ve really raised the bar by saying that the new challenge is taking these potential research solutions and really industrializing them into a commercial solution.
“Individually, each of the technologies [for a clinical MRM-MS workflow] exists, but that doesn’t mean that anyone has actually been able to take and [perform] a protein biomarker panel as a diagnostic in a commercial way,” he added. “Integrated Diagnostics is arguing that they will be the first to do that, and the opportunity we have is to help them really industrialize these tools into one robust solution.”
Agilent has been working on the problem of optimizing MRM-MS assays for clinical use for several years by collaborating with Leigh Anderson to optimize workflows for his stable isotope standards and capture by anti-peptide antibodies, or SISCAPA, assay.
Unlike the MRM-MS methods Integrated is pursuing, SISCAPA involves an antibody-capture step, but otherwise, the techniques are quite similar. At the Association for Mass Spectrometry's Applications to the Clinical Lab meeting in February 2011, Anderson presented an automated SISCAPA workflow using an Agilent Bravo liquid handling system for sample prep attached to an Agilent 1200 series LC system and an Agilent 6490 triple quadrupole instrument (PM 2/11/2011). Automation is seen as key to moving MRM-MS into the clinic due to its potential to increase assay throughput and decrease the variability associated with sample-preparation steps.
In addition to this automation work, Agilent has been experimenting with several newly acquired technologies that could make MRM-MS more clinically viable. Among them is the RapidFire high-throughput separations platform that it obtained in its March purchase of Biocius Life Sciences, a firm once headed by current Integrated CEO Albert Luderer.
Also potentially important to Agilent’s clinical mass spec ambitions is the acquisition in December of Madison, Wis.-based fluidics firm Biosystem Development, maker of AssayMap microchromatography cartridges – a technology that could prove useful in reducing the variability associated with trypsin digestion. At the JP Morgan Healthcare Conference in San Francisco this week, Nick Roelofs, president of Agilent's life sciences business, highlighted this as a key recent acquisition (See story, this issue).
“Not only do a lot of our current capabilities address [Integrated’s] needs,” Salem said, “but a lot of our strategic acquisitions may actually blend together into potential improved workflows and improved solutions.”
Integrated is currently focusing on bringing two proteomic tests to market – one for the early detection of lung cancer and another for early detection of Alzheimer’s disease. Both are being built using MRM-MS, with the company investigating around 350 proteins for each – a number that Integrated president and chief scientific officer Paul Kearney said would probably be winnowed down to 10 to 20 proteins in the final test.
Integrated and Agilent “are very much aligned in our vision of MRM mass spec for the development and delivery of clinical diagnostics,” Kearney told ProteoMonitor. “We both believe that this is the way of the future.”
He added that Agilent’s association with Leigh Anderson and SISCAPA technology was also appealing, noting that, while the company had no plans to use the technique in its first generation of tests, “it is certainly something we would look at for a second version.”
Integrated expects its lung cancer test to be first to market. It just completed a multi-site study for the test involving “hundreds of samples,” Kearney said, and is aiming for a commercial launch in early 2013.
The company plans to offer the test as a CLIA-based product instead of taking it through the FDA approval process. While Kearney acknowledged the looming possibility that FDA may begin regulating lab-developed tests, he said that “it’s hard to know what’s going to happen [in this regard]. What most people agree on is that it’s unlikely to happen anytime soon.”
“We’ve looked into companies that have gone to FDA and companies that haven’t in this sort of space, and you can lose market share by not being the first to market [because of] taking an FDA approach,” he said.
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