NEW YORK – With its recent licensing deal with Siemens Healthineers, Quanterix has taken a step toward the clinical market.
The agreement, under which Quanterix will give Siemens access to antibodies to the neurofilament light chain (Nf-l) protein, provides the Billerica, Massachusetts-based immunoassay firm with an opportunity to explore the clinical utility of the Nf-l marker without having to move its instrumentation into the clinical space.
"We can partner with companies like Siemens to further advance the clinical validity of the Nf-l technology on their platforms where they have already a pretty formidable installed base," said Kevin Hrusovsky, Quanterix's president, chairman, and CEO.
According to details presented last week during Quanterix's Q3 2019 earnings call, Siemens plans to develop a blood-based Nf-l assay for multiple sclerosis monitoring applications.
Nf-l is a marker of neuronal damage and a major revenue driver for Quanterix, accounting for around 20 percent of the company's sales. In June, the company acquired Umeå, Sweden-based Uman Diagnostics, a supplier of Nf-l antibodies and ELISA kits, for $22.5 million.
In addition to multiple sclerosis, the marker has shown potential utility for diagnosing, prognosing, and monitoring a range of neurological conditions including Alzheimer’s disease, Parkinson’s disease, traumatic brain injury, ALS, and Huntington’s disease. A study published in January found that measuring the rate of change in patient Nf-l levels allowed them to distinguish carriers of a mutation linked to familial Alzheimer's more than 16 years before the onset of symptoms.
Quanterix's single-molecular array (Simoa) immunoassay technology is distinguished primarily by its high sensitivity, which according to the company is roughly a thousandfold better than a conventional ELISA. While this high sensitivity allows researchers to discover and work with biomarkers expressed at levels undetectable by other systems, it would also seem to limit the reach of such markers to Quanterix's relatively small (at present) installed base and the research-only market.
The Siemens deal suggests, though, that some markers developed using the Simoa technology could be transferrable to less sensitive in vitro diagnostic systems, providing a route for Quanterix to gain exposure to the clinical market even before it takes its instruments through the regulatory process.
Quanterix has said that it ultimately aims to develop a clinical version of the Simoa technology. Last year it ended a license agreement with BioMérieux that gave the latter firm rights to commercialize Simoa for IVD purposes. Termination of the agreement "unlocks our long-term value creation opportunity in the estimated $30 billion IVD market," Hrusovsky said at the time.
Hrusovsky said Quanterix believes that the high performance of the Nf-l antibodies produced by Uman make the marker suitable for use on platforms that don't offer the Simoa system's level of sensitivity.
"Our hope is that our ability to engineer sensitivity into the markers… will enable use cases by partners like Siemens and some of the other big diagnostic firms that have incredibly large installed bases," he said. "So we're encouraged by this particular biomarker."
On the company's Q3 earnings call Hrusovsky noted that Quanterix's goal is to work with Siemens to get a "validated and clinical relevant IVD kit for Nf-l" onto that company's installed based of clinical analyzers, which he said numbers around 10,000 instruments.
He also highlighted Quanterix's interest in working with other major IVD vendors to develop Nf-l assays for their systems, adding that the company believes "that the other diagnostic houses would be well served to advance their own positions relative to Nf-l, and we would certainly be open to additional contracts."
He cited, in particular, Roche and what he said was that company's installed based of around 70,000 instruments and added that Quanterix could enter two or three deals like the Siemens agreement over the next year.
Quanterix has also licensed the Nf-l antibodies to Minneapolis-based Bio-Techne for use on that company's Simple Plex immunoassay system.
While Quanterix expects Nf-l and other markers that it and its collaborators are working with, using the Simoa technology, can be moved to more traditional IVD platforms, Hrusovsky said the clinical market still represented a significant opportunity for the Simoa technology, given that its higher sensitivity would allow it to, for instance, run multiplex assays that could prove more clinically useful than a single marker, or run tests using small sample sources like dried blood spots.
"Most of the major diagnostic companies are doing tests in single plex," he said. "And what typically happens when you add other markers is you lose some sensitivity. So one of the things that we are really focused on is ensuring that we have plenty of sensitivity headroom to enable us to combine other markers with Nf-l because we believe that in the future the diagnostics industry is going to benefit from multiplexing and looking at various markers at once," Hrusovsky added, noting that because Nf-l is a non-specific marker for neuronal death, multiplexing other markers with it could help researchers and clinicians better understand "what condition is actually creating that neuronal deterioration."
In that vein, Mathias Jucker, a professor at the German Center for Neurodegenerative Diseases (DZNE) and senior author on the Nf-l Alzheimer's study, said that he and his colleagues were now hoping to combine plasma Nf-l measurements with plasma measurements of the traditional Alzheimer's marker amyloid-β.
Hrusovsky declined to elaborate on the terms of the agreement and whether Quanterix would receive royalty on sales on any Nf-l IVD Siemens ultimately developed but said that the company was "trying to ensure that we participate in the most complete way possible."