This story has been updated to correct a description of the Simoa technology.
NEW YORK (GenomeWeb) – Quanterix announced today the launch of an early-access program for a new immunoassay platform targeted at the oncology research space.
Called the SP-X Imaging and Analysis system, the benchtop platform combines Quanterix's high-sensitivity Simoa immunoassays with higher levels of multiplexing than are offered by its existing systems. According to Kevin Hrusovsky, Quanterix's CEO, president, and chairman, the company plans to launch the SP-X in the first half of 2019.
Quanterix' Simoa technology is a detection system consisting of an optical fiber bundle to carry light in and out of each reaction well, a proprietary image-capture device, and image-analysis software to allow researchers to observe these assays on a single molecule level.
To date, the company has used a bead-based approach in its Simoa platforms, but the SP-X system will use a planar technology, which Hrusovsky said provided the quickest and most economical route to expanding the technology's multiplexing capabilities.
Quanterix acquired its planar immunoassay technology through its acquisition of Aushon Biosystems in March. Aushon produces arrayer technology that allows production of highly multiplexed immunoassays. The company's Ciraplex assays, for instance, feature as many as 12 antibodies per well spotted across 96-well plates.
Hrusovsky said that higher multiplexing is key to Quanterix's move into the oncology space. Its benchtop SR-X system can currently measure four analytes at once, and the company is working to expand that to six analytes. The SP-X will multiplex 10 analytes upon launch and could potentially go to higher plexes in the future, Hrusovsky said.
"Our current platforms are perfect for the neurology landscape, but they're not sufficient for [oncology]," he said. "In oncology, you really need to have a much broader panel, because cancers mutate, and there are a lot of challenges with these new immunotherapies to try to understand why with some people the drugs work and with some people they don't."
Hrusovsky said Quanterix will initially launch a ten-plex cytokine panel for use on the SP-X that will feature "what we consider to be some of the most important cytokines in immunotherapy research."
The panel will help researchers explore questions around patient response to immunotherapies, including the development of adverse effects, he said. "For instance, why is it that some patients go into a cytokine storm?"
"That could be better assessed and managed if you could measure with high sensitivity the cytokines and small movements [in their expression]," he said. "We're hopeful that being able to get to this [high] sensitivity on these 10 cytokines will play out very productively in the immunotherapy landscape."
In addition to immunotherapy, the company plans to develop assay panels for studying cancer angiogenesis and other research areas.
"Just like we've done in neurology, we believe there'll be a lot of interest in moving these into … clinical trials," Hrusovsky said. "We'll be on the lookout for how we can be effective in helping get drugs moved to the market."
The launch of the SP-X is part of Quanterix's larger plan to move from neurology, which is currently its main area of activity, into oncology and ultimately into the diagnostic space.
According to Hrusovsky, of the nearly 300 peer-reviewed publications using Quanterix's technology, more than 150 were neurology focused, and of the 207 different biomarkers run on the company's systems, 99 have been neurology markers.
"We still have a lot of growth opportunity in neurology," he said, but he added that the company estimates its opportunity in the oncology space is between three and five times the size of that in neurology.
"The SP-X will be our first major entrée into that landscape," he said.
Quanterix is doing a beta rollout over the next several months that Hrusovsky called its "testbed."
"We want to get the instruments into the hands of a lot of interested oncology researchers and learn from them whether we have what we think we have," he said. "We really want to make sure we assess the market opportunity before we launch in a major way in the first half [of 2019]."
He added that the company has thus far placed prototypes of the instrument with three customers.
Quanterix declined to provide pricing for the new instrument but said it would be comparable to the SR-X system, which runs around $75,000.
Hrusovsky said that while Quanterix plans to eventually tackle the clinical market, the SP-X is designed for research, without the full end-to-end automation provided by the company's HD-1 system.
"The HD-1 is a better diagnostic machine," he said. "It's fully automated. You put the blood in and you get the answer out."
The HD-1 was Quanterix's first instrument launch, and a legacy of its original focus on the diagnostic market, Hrusovsky said.
"When I first joined the company four years ago, we really were not focused on research markets, we were focused on diagnostic markets," he said.
As the company became more research-focused, it recognized the need for a less expensive, benchtop instrument capable of higher multiplexing, which led to the launch of the SR-X.
"Our view is it's better to enter [the oncology market] with the benchtop [SP-X] and then, subsequently, create the HD-1 kind of automation," he said. "What we want to do is get the initial platform out there, let the researchers begin using it, and then later on, if, in fact, it goes down the same path that we saw happen in neurology, we would consider launching a fully automated oncology machine."
While entering the cancer diagnostics market remains a longer-term goal, Quanterix recently announced a collaboration with OncoGenesis on a test for cervical disease that is intended, in part, to lay the groundwork for such an entry.
Under the collaboration, the companies will develop the protein biomarker-based test using the SP-X system, and OncoGenesis will handle test commercialization. Called CerMark, the test will measure protein markers linked to high-risk HPV infection and cervical disease progression.
On a conference call following release of the company's Q3 earnings last week, Hrusovsky noted that the collaboration would give the company an opportunity to "see if our technologies can be deployed productively in that [clinical] landscape" while also giving it a chance to learn more about the US Food and Drug Administration regulatory process.