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Somalogic Predicts $20M-plus in 2014 Revenues from SOMAscan Product as Services Business Takes Off

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While its diagnostic ambitions continue to progress slowly, proteomics firm Somalogic appears to be carving out a substantial market for its SOMAscan protein biomarker discovery platform, generating $10.5 million in revenues from the product in 2013.

The company expects these revenues to more than double in 2014, Chief Medical Officer Steve Williams told ProteoMonitor this week, as it begins placing the platform in academic and contract research centers under a collaboration with Agilent.

Assuming this projection comes to pass, the company would notch more than $20 million in SOMAscan revenues in 2014. By way of comparison, Rules-Based Medicine – generally considered the leader in protein biomarker discovery services – generated roughly $25 million in revenues in 2010, the year before it was purchased by Myriad Genetics for $80 million.

The SOMAscan platform uses SomaLogic's Slow Off-rate Modified Aptamer, or Somamer, affinity reagents to simultaneously quantify 1,129 protein analytes. These Somamers – essentially short strands of DNA – bind to protein targets in a sample of interest. They can then be quantified via microarrays, with the quantity of a given Somamer corresponding to the quantity of its target protein.

The platform, which uses custom Agilent microarrays for Somamer quantification, is able to work with samples as small as 65 μL and with a throughput on the order of hundreds of samples per day. The assays have a median lower limit of detection of 40 femtomoles.

Since launching the platform two years ago, Somalogic has run more than 40,000 samples as part of more than 140 studies. In 2013, the company performed more than 100 studies on the platform for customers including 25 biopharma firms and 10 academic clients.

Somalogic has traditionally positioned itself as a diagnostics firm, but, given its success with the SOMAscan platform, it appears to be morphing into something more resembling a proteomics tools and services vendor.

"We have publicized ourselves as a diagnostics company, and we haven't lost sight of that, but this is such a powerful discovery engine that we can't exploit all of the value out of it for our own diagnostics pipeline," Williams said.

Beyond matters of the company's diagnostics bandwidth, there is also the fact that the SOMAscan platform is generating significant, and growing, revenues – an achievement that has to date eluded the vast majority of proteomic diagnostics efforts, Somalogic's included.

The firm has diagnostic programs underway in a number of areas, most prominent among them lung cancer and cardiovascular disease, however, it has yet to launch any diagnostics commercially.

Its lung cancer test – which, like Integrated Diagnostics' recently launched Xpresys Lung test is aimed at identifying false positives in lung CT scans – consists of a seven-protein panel identified using the Somamer technology. The company has licensed the test to Quest and, Williams said, commercialization efforts regarding the test are "in Quest's hands." In the past, Somalogic identified 2011 and 2012 as anticipated launch dates for the product.

With regard to the CVD test, Williams said the earliest that test could come to market is 2015. The company currently has an 11-protein panel that, he said, has demonstrated "clear evidence of prognostic power, prediction of risk." However, he added, Somalogic now hopes to demonstrate that the panel can detect changes in risk due to interventions.

"The way we would like it to be used is not just that people use it once to predict 10-year risk, but that they use it to measure again after some intervention to see if someone's risk is getting less or not," Williams said. He said he expected the company would define the optimal panel of proteins for this purpose by the end of the year, at which point it plans to take it to market as a laboratory-developed test and then, eventually, to take it through US Food and Drug Administration 510(k) clearance.

The proteomics diagnostics business has proved a challenging one, however, Williams said, noting the "reimbursement uncertainties and regulatory uncertainties and validation uncertainties" inherent in this work.

With the SOMAscan business, on the other hand, "the reimbursement is certain and there are no regulatory issues," he said. "It's great to have that engine to help the company thrive while it develops these breakthrough [diagnostic] products."

Williams compared the company's plans to start selling the platform into core labs and CROs to Illumina's business model of selling "services along with instruments and kits."

"That is the life sciences model we are pursuing, and that will fuel the diagnostics development side of things," he said.

The SOMAscan platform currently features assays to 1,129 proteins, and Somalogic plans to have Somamers for 3,000 proteins by the end of the year. The SOMAscan offerings typically lag the company's total reagent count, however, Williams said, due to the time required to validate new expansions to the panel.

"The rate-limiting step to expanding the assay isn't making the reagents, it's all of the analytical validation we have to do when we produce a new version," he said. "We extensively characterize the assay in terms of making standard curves and looking at the specificity of the reagents, which is a very considerable piece of work."

Williams said that in addition to expanding the panel, the company might also in the future offer smaller, customized panels for researchers investigating specific questions – a service it currently offers only to its SOMAscan clients.

The key advantage of such smaller panels would be price, he noted.

"The highest cost at the moment for the large [SOMAscan] array is the Agilent [hybridization] slide, and if you are moving down to a small number of measurements, then you don't have to use a hybridization slide, you can use [for instance] qPCR or Luminex beads," he said.

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