Biotech firm NextGen Sciences this week launched a plasma protein biomarker discovery panel based on its multiple-reaction monitoring mass spectrometry platform.
Called plasmadiscover41, the panel comprises 41 plasma proteins thought to be potential biomarkers for breast, prostate, and lung cancer. The company is also working on a 50- to 60-protein panel for cerebrospinal fluid biomarkers linked to various central nervous system diseases that it plans to introduce in the second quarter of this year.
According to NextGen CEO Barry McAleer, the product's release is part of the company's recent shift in strategy toward applying its technology to more specific therapeutic needs.
Traditionally focused on providing custom biomarker services for pharma and biotech firms, NextGen has to date "really waited for projects to come to us," McAleer told ProteoMonitor.
"But if you want to grow a business, you need to become relevant to therapeutic areas," he said. "That allows you to market those therapeutic areas, build your reputation in those areas, and grow a business."
Moving into the discovery panel space is in part an immediate tactical approach to generating cash, McAleer said, but, he added, "it's also a way of finding more lucrative projects" in the diagnostics and personalized medicine space.
"It's quite hard to do that when you're just selling MRM technology, because people don't see the relevance," he said. "But if you're selling assays that target specific biological questions, then you can apply your technology and people see how that can be done."
NextGen is the second company to enter the biomarker discovery panel business in recent weeks, following Olink Biosciences, which last month launched a 74-protein panel of oncology markers based on its proximity ligation assay-based immunoassay platform. Olink plans to add another 100 proteins to the panel within the year, chief scientific officer Simon Fredriksson said recently (PM 3/11/2011).
Rules-Based Medicine remains the leading player in the plasma biomarker discovery field, with more than 250 different proteins in its Human DiscoveryMAP product and a variety of other panels covering indications including various cancers as well as central nervous system, kidney, and cardiovascular diseases.
Last week, discussing Olink's entry into the field, Peter Levine, CEO of diagnostics firm Correlogic, cited this breadth of offerings as key to RBM's dominance. Although NextGen is launching its first panel with just 41 proteins, McAleer said the company believes that its MRM mass spec platform will allow it to quickly catch up to RBM which, like Olink, uses an immunoassay-based system.
Developing an MRM protein assay takes NextGen around four months, he said, compared to up to a year for antibody-based approaches.
McAleer also said the company hoped to compete with RBM based on the proteins selected for its panels, suggesting that some of that firm's success has been due to a lack of competition in the field.
"If people wanted to do [protein biomarker] discovery, they just tested [their sample] against the Rules-Based Medicine panels because there was nothing else," he said. "What we're looking to do is go for panels that do have better content, and ultimately with MRM we think we can grow our assay panels faster than [RBM] can, so we should be able to catch up."
NextGen plans to add 50 to 100 proteins to its plasma panel business sometime this fall, McAleer said.
He also called into question the variability of RBM's platform, saying that "we know that with RBM people do see issues with batch-to-batch variability."
"For us the initial goal would be that when somebody wants to do discovery, instead of giving $100,000 to RBM, they might give $50,000 to NextGen and $50,000 to RBM," he said. "Then as we grow the business they should start to see that we get good data and hopefully we can draw more money our direction."
In an e-mail to ProteoMonitor, RBM vice president of corporate development Sam LaBrie said that "all of [the company's] analytes are measured with quantitative immunoassays in our CLIA-certified lab" and that RBM processes "every sample alongside calibrators and controls in order to provide consistent results."
LaBrie added that "it remains to be seen if MRM can perform at a comparable level."
Traditionally, variability has been a bigger issue for trypsin digest-based mass spec techniques like MRM than for immunoassays. McAleer said that NextGen has carefully standardized its workflow, however, and has CVs below 15 percent for all 41 of its plasma assays. According to data on RBM's website, of the firm's 250-plus human protein assays, 32 percent have CVs below 5 percent; 56 percent have CVs between 5 percent and 10 percent; 9 percent have CVs between 10 percent and 15 percent; and 3 percent have CVs between 15 percent and 20 percent.
More than variability, lack of sensitivity is an issue for MRM approaches like NextGen's. While immunoassay-based platforms like those used by Olink and RBM can detect proteins in concentrations as low as tens of femtomoles, MRM detects down only into the high picogram-per-mL range.
McAleer acknowledged this limitation, noting that it could lead the company to focus in part on assaying proteins for which good antibodies don't currently exist.
"For some cytokines or inflammatory markers you probably wouldn't use an MRM assay because you wouldn't get down to that [concentration level]," he said. "Having said that, most of those have antibodies out there now, so you wouldn't need to move into that competitive space anyway – there'd be no point."
He added that the company was looking into immunocapture-MS techniques like SISCAPA that it could offer customers looking for more sensitive assays to pursue proteins of interest identified in the initial discovery screening.
"We're going to see how MRM plays out and then we'll make a decision about whether to get into SISCAPA or whether we want to get a hold of antibody technology and use MRM as the swift upfront qualifier and then use antibodies to develop more specific assays," he said.
Currently NextGen has one customer for the plasmadiscover41 service and a "verbal purchase order" from another, McAleer said. It also has several clients lined up for its forthcoming CSF panel, he added.
Moving forward, the company plans to target what McAleer called "key academic and clinical opinion leaders," which he sees as "a route into important projects in pharma and biotech" as well as sources of information and samples for determining additional proteins for its panels.
Currently, he said, the company is pursuing collaborations on its CSF platform with the Michael J. Fox Foundation and the National Institutes of Health's Alzheimer's Disease Neuroimaging Initiative.
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