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With New Instrument, Quanterix Addressing Customer Demand for Increased Flexibility, Lower Price


NEW YORK (GenomeWeb) – With the launch this week of its SR-Plex benchtop instrument, Quanterix is looking to meet what the company describes as customer demand for a more flexible and versatile assay system, while at the same time improving its multiplexing capabilities.

When the Lexington, Massachusetts-based firm launched its original Single Molecule Array (Simoa) platform, the HD-1 Analyzer, in 2013, it was focused primarily on high-sensitivity protein assays. Since then, however, the system has drawn significant interest among nucleic acid researchers, said Kevin Hrusovsky, Quanterix's executive chairman and CEO, and the SR-Plex release is aimed in part at addressing this set of users.

The HD-1 includes integrated sample prep steps designed for protein assays, making it something of an awkward fit for nucleic acid work. The SR-Plex is a simplified version of that system that essentially leaves off the front-end sample prep module, allowing researchers to use whatever protocols they want.

"Many individuals have asked us, 'Can we do DNA and RNA and microRNA in your machine, as well?'" Hrusovsky said. "And by [removing the sample prep module], we've enabled that."

Quanterix's Simoa technology uses arrays of femtoliter-sized reaction chambers designed to isolate single molecules, enabling each well to serve effectively as an independent assay for a single molecule. A detection system consisting of an optical fiber bundle to carry light in and out of each well, a proprietary image-capture device, and image-analysis software allow researchers to observe these assays on a single-molecule level.

Proteins have been the company's main area of focus to date, but, as Hrusovsky noted, it has drawn interest from nucleic acid researchers who view the platform as interesting for its ability to measure these molecules without requiring amplification steps like PCR.

"We can take the sensitivity of this reader and apply it to nucleic acids," he said. "So, now you can look at native DNA, RNA, microRNA samples and get a read-out of what's there much more precisely because you don't have the bias of PCR and the thermocycling and all that prep."

In addition to increased flexibility and a smaller physical footprint, the SR-Plex also offers improved multiplexing, Hrusovsky said, adding that the company is releasing a six-plex cytokine assay with the new platform.

He suggested that this advance could drive sales of the new system among the company's existing protein research customers, especially for assay development purposes.

The company also expects that the lower price of the SR-Plex system (around $75,000 versus roughly $165,000 for the HD-1), will attract buyers among researchers who currently run samples through Quanterix's services business.

Research services "is the fastest growing part of our company," Hrusovsky said. "And some of those customers wanted to be able to get into the [Simoa] technology at a lower price point. They already had plenty of in-house sample prep, and they just wanted a reader. So, we think there are a lot of customers who didn't buy the HD-1 because it was too big of an investment who will buy this one."

The move to decouple sample prep from sample analysis runs counter to the trend in other molecular approaches where in many cases researchers and vendors are working to more thoroughly integrate all stages of a workflow. Hrusovsky said that the company does not currently have plans to offer a platform with integrated nucleic acid sample prep, but it could if customer demand warrants such a move.

"If there's enough interest, it would be pretty easy for us to put a front end on," he said.

Quanterix, he noted, has raised around $55 million in the last year and a half, including an $8.5 million private placement this month and a $46 million Series D funding round in March 2016. Ongoing instrument design, primarily around continued miniaturization is one of the main purposes to which the company is putting those funds.

Another major focus is expanding the company's assay menu, particularly in neurology, oncology, and infectious disease, Hrusovsky said, noting that it currently offers almost 100 off-the-shelf assays.

The Simoa technology's high sensitivity, he suggested, makes it particularly suited to exploring analytes like neurology markers in blood, which are typically present only at very low concentrations due to the difficulty of crossing over the blood-brain barrier.

Quanterix also sees an opportunity for its technology in immune-oncology, where Hrusovsky said it believes it could improve measurement of molecules like PD-L1 compared to conventional immunohistochemistry methods.

While its current platforms are intended for research use, the company is also eyeing the clinical market and has established several relationships that could help it address this space. In 2012 it signed an agreement with BioMérieux giving that company worldwide exclusive rights to the Simoa technology for in vitro diagnostic purposes, and Hrusovsky said that if the company were to pursue development of an IVD version of Simoa, BioMérieux would lead that effort.

At the same time, Quanterix is working with outside companies pursuing laboratory-developed tests and "may also evolve our own investments into this area," Hrusovsky said.

To date, Quanterix has placed around 155 instruments, most of which were purchased by pharma and biotech firms, Hrusovsky said. The privately held company generated $18 million in revenues in 2016, up from $12 million in 2015 and $4.5 million in 2014.

Hrusovsky said that currently around 20 percent of the company's revenues come from its services business, with another 20 percent coming from consumables, and the remaining 60 percent attributable to instrument sales. He noted that this mix is shifting, though, with services and consumables expected to make up an increasing portion of revenues in coming years.