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SomaLogic Enters Clinic With Launch of First Test Based on SomaScan Platform

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NEW YORK – Proteomic diagnostics firm SomaLogic is pushing its aptamer-based technology into the clinic with the recent launch of the first tests on its SomaScan platform.

The Boulder, Colorado-based company announced this month that it would begin offering seven proteomic tests at several Colorado doctors' practices. The releases mark SomaLogic's first move into clinical testing after several years of development work.

The assays, sold under the name SomaSignal, will test for risk of major cardiovascular events in patients with and without known heart disease; whether patients show the effects of heavy drinking; patient aerobic fitness levels; the presence of excess liver fat; and percent body fat and lean tissue.

According to Somalogic CEO Roy Smythe, the company plans to offer the tests through four practices initially and then roll it out to additional practices in Colorado and around the country.

"The first markets we're releasing the test in are what would be considered concierge-type medical practices," he said, adding that the company also plans to target "executive health, self-pay type practices where individuals are contracting with physicians for more personalized care."

From there it will target health systems and ultimately the direct-to-consumer market, which it hopes to enter over the next several years, Smythe said. He added that while the company is launching seven SomaSignal tests initially, it currently has around 100 additional tests in its pipeline. It plans to launch another three to four tests by the end of the year.

Commercializing proteomic tests has proved a difficult endeavor, with few such products making it to clinic and even fewer finding success in the market. SomaLogic has the added challenge of moving forward with a relatively novel model of test building and marketing.

While diagnostic companies typically develop narrowly focused assays containing small numbers of analytes and using reagents that have been put through rigorous analytical validation, SomaLogic is essentially counting on the scale and throughput of its SomaScan platform to enable rapid test development.

The SomaScan platform uses the company's aptamer-based affinity reagents called Somamers to measure proteins in patient samples, typically blood. The platform currently measures 5,000 proteins per sample, and SomaLogic believes that measuring this large number of proteins across large numbers of samples will provide it with the data it needs to identify correlations between protein measurements and patient health that it can package as tests.

The company has entered collaborations with parties including DeCode Genetics and the Leeds Centre for Personalized Medicine and Health to test its platform in large patient cohorts with the aim of building clinical assays to assess questions including a patient's risk of having a cardiovascular event or developing diabetes.

Thus far, Smythe said, SomaLogic has run the 5,000-plex version of SomaScan on around 100,000 patient samples and a smaller 1,300-plex version on around 200,000 samples.

The company's approach has raised questions from some researchers about how rigorously it will be able to validate its many thousands of reagents. Addressing these questions earlier this year, Alan Williams, Somalogic's chief development and operations officer, said that the company is "generally treating the [SomaScan] platform as a semi-quantitative platform, as opposed to treating it as an analytical platform like you might do with an analyzer. And what we're doing is using that semi-quantitative platform with the 5,000 analytes to directly build models against clinical end points."

Ultimately, Williams said, the company's strategy is based on making measurements in large cohorts and observing reproducible signals that they can train against specific endpoints.

As Williams acknowledged, whether clinicians are comfortable adopting tests based on such an approach remains to be seen.

Another potential challenge lies in the large number of tests the company plans to offer. Typically, commercialization of a new clinical test involves substantial investment in physician education as firms have to convince clinicians that their assay offers improvement over existing standards of care. It's unlikely such a sales model can scale to a pipeline featuring upwards of 100 tests, particularly for a relatively small firm like SomaLogic.

Instead, Smythe said, the company is counting on the cost and convenience of its tests as well as the breadth of its offerings to drive adoption.

"It's not a single test that is attractive on this platform, it's the breadth of things that we'll be able to offer," he said. "You think about the ability for a clinician to measure not only cardiovascular risk but 15 other things that could give the clinician information about how to lower that person's cardiovascular risk from a single blood draw versus having to run that person through 10 or 11 expensive and time-consuming tests that they just aren't going to do."

SomaLogic will charge $199 for the package of seven tests until the end of the year. After that the price will rise to $599. It is offering them as laboratory-developed tests out of its CLIA facility, but long-term the company plans to develop its tests as DTC products, taking them through the US Food and Drug Administration as required.

"A lot of our health and wellness tests we'll be able to deliver [DTC] under an LDT approach," Smythe said. "The tests that veer more into disease prediction or management will either require that a physician be in the loop or that we contemplate more of an FDA approval approach. We are currently in discussions with the FDA about that and will continue working with FDA over the next couple of years about what the best approach will be."

Smythe, who was a surgeon at University of Texas MD Anderson Cancer Center, said he was keen to avoid the travails of the DTC genomics business.

"I was a clinician when the first direct-to-consumer genomics products were offered," he said. "And I can remember sitting in my clinic and literally scratching my head when people came in with [DTC genomic] printouts, not really understanding what they meant or what to do with them. We don't want to repeat that scenario, not from the standpoint of clinicians and consumers and certainly not from a regulatory standpoint," he said.