After spending most of its four-year existence building protein-biomarker tests for use with its Single Molecule Array protein-detection platform, biotech firm Quanterix is shifting its focus from diagnostic development to building and selling the SiMoA platform itself.
The company is currently developing a research-use-only version of the instrument that it aims to launch commercially in 2013, with a US Food and Drug Administration-approved version of coming sometime after that, Quanterix CEO David Okrongly told ProteoMonitor.
Quanterix plans to manufacture the RUO device through an outside vendor because most of the components and consumables for it off-the-shelf, Okrongly said. There "really wasn't a great value-add for us doing it internally," he added.
As recently as last June, the firm had touted plans to begin selling a CLIA-based prostate-cancer diagnostic run on its SiMoA platform by 2011 and an Alzheimer's diagnostic by 2012.
However, it's now unlikely either test will make it to market before the instrument goes on sale in 2013, Okrongly said. The commercial launch of a SiMoA system "is going to be the main goal for this company for the next year and a half," he added.
Such a launch has always been an internal part of Quanterix's strategy, Okrongly said, adding that developing and selling in vitro diagnostics for use on the platform remains "the endgame for the company."
Its transformation into an instrument vendor was brought about after the company realized that "to really maximize the pipeline of our in vitro diagnostics we've got to get the product in the hands of academic and pharma researchers who are going to apply it in areas [where] we just don't have the bandwidth," he said.
Uncertainty over the FDA's role in regulating laboratory-develop tests – a category that would include Quanterix's prostate cancer and Alzheimer's diagnostics – also contributed to the shift in strategy, Okrongly said.
This summer the agency said it planned to begin regulating such tests after years of taking a hands-off approach it called "enforcement discretion" (PGx Reporter 7/21/2010). The FDA is currently developing a guidance covering the changes that it expects to release sometime this spring.
Okrongly said the company also came to realize that – even if it were to bring its planned prostate-cancer diagnostic to market –given its current throughput it wouldn't be able to process enough tests "to achieve our market goals."
"We run about 1,000 samples a week in-house, which is fine for a limited number of collaborations and our own internal work," he said. But a successful commercial diagnostic "would demand several orders of magnitude of [the] production capacity we have today with just our own internal bandwidth."
"So we really didn't want to get into a situation where we couldn't satisfy needs for a launched product." he added.
Although the initial instrument will be RUO, Okrongly said the plan is to get FDA-approved versions into large clinical reference laboratories like Quest Diagnostics and LabCorp, as well as hospital laboratories.
The idea, he added, is that if a research version of the instrument is available, scientists and pharma companies can use it for diagnostics development work, hopefully generating IVD products that will then drive reference-lab demand for the platform.
"What we'd like to do is expand our shots on goal from the dozen or two dozen [indications] that we'll be able to explore and [instead] sell this instrument to thousands of labs that will explore" the platform's diagnostic potential," he said.
According to the business model the company currently envisions, these customers would have licenses to use the instrument for research only, Okrongly noted. To sell a regulated IVD they'd developed for use on the platform they would have to purchase a license for the diagnostic from Quanterix.
Thus far, the company has focused primarily on tests for prostate cancer and neurodegenerative diseases. Now, though, it plans to expand its efforts to diagnostics for other cancers, infectious disease, and autoimmune disorders and establishing relationships with other researchers and biopharmas "to produce a lot of results in anticipation of production of our instrument," Okrongly said.
To those ends, this week Quanterix announced it has signed a technology-evaluation agreement with Novartis Diagnostics under which Novartis will use the SiMoA platform to measure an undisclosed neuronal protein.
Also this week, the journal Analytical Chemistry published a study by Quanterix scientists in which they combined digital and analog detection modes to extend the instrument's dynamic range from 2.5 logs of concentrations to 4.1 logs.
In the paper, the researchers said they hope to further extend the device's range by 1 to 2 orders of magnitude by improving the speed of the imaging system and minimizing substrate depletion.
The SiMoA platform works essentially like an ELISA, but uses arrays of femtoliter-sized reaction chambers designed to isolate single molecules, enabling each well to serve as an independent assay for a single molecule.
It uses 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 to allow researchers to observe the assays on a single-molecule level.
According to Quanterix, the platform offers a 1,000-fold improvement over conventional ELISAs, taking immunoassays down into the sub-femtomolar range and potentially enabling the resulting assays to detect low-abundance protein biomarkers.
In a study published in the June issue of Nature Biotechnology, the firm's researchers demonstrated the platform's ability to detect prostate-specific antigen in the blood of patients who underwent radical prostatectomies. The results showed PSA levels at concentrations as low as 0.4 fM – roughly 1,700 times more sensitive than a typical ELISA (PM 06/11/2011).
Quanterix, headquartered in Cambridge, Mass., launched in 2007 and raised $15 million in venture capital through 2008. According to a document filed on Oct. 12, 2010 with the US Securities and Exchange Commission, the company said it expects to close a $5 million financing round in the form of options, warrants, or rights to acquire another security (PM 10/15/2010). As of the filing the company had raised $2.5 million from a total of nine investors.
Citing SEC regulations, Okrongly declined to say if the firm would be raising addition funds to help it commercialize the SiMoA instrument.
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