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Quanterix Continues to Use Partnerships to Drive Clinical Strategy

NEW YORK — Quanterix took another step toward the diagnostics market last week with an agreement to license its high-sensitivity immunoassay technology to Abbott Laboratories.

The non-exclusive license allows Abbott to incorporate Quanterix's Simoa technology into its in vitro diagnostic platforms in exchange for an initial $10 million license fee, milestone fees subject to the achievement by Abbott of development, regulatory, and launch milestones, and royalties on the sales of licensed products.

The deal allows Quanterix to pursue diagnostic uses for the Simoa technology without having to invest in developing and selling its own clinical platform. In this sense, it is similar to the licensing deal the company signed last year with Siemens Healthineers for use of its neurofilament light chain (Nfl) protein marker, though that agreement only covered Quanterix's antibodies to the protein and not aspects of the Simoa technology.

Regarding the Siemens deal, last month Siemens announced that it was collaborating with Novartis to develop a serum Nfl immunoassay for testing patients with multiple sclerosis and other neurological diseases. Quanterix President, Chairman, and CEO Kevin Hrusovsky said Siemens was using the Nfl antibodies it licensed from Quanterix for this work.

Quanterix regained control of its IVD portfolio following the 2018 termination of an exclusive license it signed with BioMérieux in 2012 that gave that company worldwide exclusive rights to Quanterix's Simoa technology in clinical laboratories and for industrial applications.

Since then it has moved to enter the clinical market through partnerships with large IVD firms, first with the Siemens deal and now with the Abbott agreement.

"We think this is a great catalyst for further validating our technology, to be able to land a non-exclusive agreement of this magnitude with one of the prestigious [IVD] players," said Hrusovsky.

He noted that beyond Abbott's standing as one of the major companies in the space with extensive reach into centralized labs, the agreement was attractive from Quanterix's perspective because of Abbott's investments in point-of-care testing, which Hrusovsky said the company saw as a potentially interesting opportunity for its technology.

The license gives Abbott rights to Quanterix's bead-based technology, including to recent advances that Hrusovsky said have allowed the company to improve the sensitivity of its platform by a hundredfold. The companies did not provide any information about what indications Abbott might use the Simoa technology for, but to date Quanterix has focused its bead-based technology largely on neurology.

Quanterix also has planar-based technology, which is not covered by the Abbott agreement, that allows for higher multiplexing of its immunoassays. In the past the company has highlighted this technology as key to penetrating the oncology market, where multiplexed assays are in higher demand.

Hrusovsky said this week that Quanterix viewed the multiplexing capabilities of its planar systems as key to diagnostics development across a range of indications and left it an open question as to whether it would consider licensing this technology at some point.

"I think in the molecular world it is very common that you multiplex, and we feel that the protein world is no different," Hrusovsky said. "And as time goes on, that will be a very important capability that we have not licensed at this point, and nor have we commented on whether we ever would. But we do think there will be an important market for multiplex panels for improving [diagnostic] specificity and precision."

Quanterix is also looking to build its own portfolio of diagnostics, Hrusovsky said, noting that the SARS-CoV-2 pandemic has opened up certain opportunities for the company to demonstrate the utility of its technology in clinical settings.

He said that Quanterix is currently working with a large private payor group running trials focused on serology testing for the virus. He added that the company is also exploring SARS-CoV-2 antigen testing in blood and saliva as well as nasal and nasopharyngeal swabs. Last week the National Institutes of Health in collaboration with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) said it has awarded Quanterix a $18.2 million Rapid Acceleration of Diagnostics (RADx) contract to develop an antigen test for SARS-CoV-2 on its platform.

In May, the company licensed a multiplex SARS-CoV-2 serology test developed on its platform by a team of researchers at Brigham and Women's Hospital led by Harvard professor David Walt, the scientific cofounder of Quanterix and a member of the company's board of directors.

"We're advancing very productively our COVID menu that we think could ultimately allow us to make advances to support this pandemic but that could also further advance our overall diagnostic opportunities," Hrusovsky said.

The company also continues to push toward the clinic with tests unrelated to the virus, specifically in neurology. Hrusovsky noted that its Nfl marker has shown usefulness both for managing patients with multiple sclerosis and for the earlier identification of people with neurodegeneration. He said that Quanterix originally envisioned a single site LDT looking at markers of neurological health in blood as its initial clinical product and noted that it was still pursuing this even as the pandemic has presented new opportunities.

He said that at least in the near term the company would pursue its LDT program in collaboration with outside labs, though he noted that the company might consider establishing its own CLIA facility in the future.

"We would like to do most of our advances in diagnostics through some level of partnership, whether it be for LDTs or IVDs," he said, but added that it was not ruling out developing and selling tests on its own "if there is an opportunity that makes sense for our investors."