Quanterix is now "shifting from an R&D phase to a commercial phase" as it prepares to launch its Simoa platform next year.
Julien Bradley, senior director of product management and product marketing at the privately held, Lexington, Mass.-based firm, told BioArray News this week that the company's recent hire of former EMD Millipore executive Paul Chapman as president and CEO is part of that transformation.
"We wanted someone who was going to be very operational and appropriate for a company at this phase," Bradley said. "Paul has depth of experience in a number of firms that would be helpful to us at this point."
Bradley added that the company plans to expand its sales and marketing operation in coming months — a strategy that may include hiring more Quanterix personnel or entering distribution partnerships with other organizations.
"We intend to go to market directly, hire our own sales team, but are certainly open to discussions with potential partners, so the final distribution strategy is still evolving. We do expect that we will be in the marketplace a year from now," he said.
According to Bradley, Quanterix will be selling its Simoa HD-1 Analyer for research use by July 2013. The system will become available with a menu of between 30 and 50 validated assays. He said the menu could include tests for prostate-specific antigen, certain cytokines, and other "common assays that we believe require more sensitivity."
Quanterix's single molecule array, or Simoa, technology is based upon the isolation of individual immunocomplexes on paramagnetic beads using standard enzyme-linked immunosorbent reagents. According to the company, the main difference between Simoa and conventional immunoassays lies in its ability to trap single molecules in femtoliter-sized wells, allowing for a digital readout of each individual bead to determine if it is bound to the target analyte or not.
Quanterix last year tapped Sony DADC to manufacture its arrays on a so-called "smart disc" (BAN 7/26/2011). Each Simoa disc contains 24 flow cells, each with an array of 200,000 microwells, according to the firm. Also last year, Quanterix partnered with Stratec Biomedical to produce an automated analysis system that could process the discs (BAN 8/16/2011).
Quanterix claims that the system offers "full automation," and that it can process 75 samples per hour, with the first results available in 30 minutes. It is also an open access system, and will support customer-designed assays. Bradley declined to provide a price for the system, but said it will be competitive with other instruments on the market that process ELISAs.
"Customers will be able to develop their own assays," said Bradley. "They can order reagents from us but use their own antibodies to develop their own assays."
The HD-1 Analyzer will initially be marketed as a research instrument to the pharmaceutical and biopharmaceutical industries and contract research organizations, Bradley said. But the company also sees research partnerships as opportunities to pursue its longer-term strategy of entering the market for in vitro diagnostics.
"The diagnostics market is the larger market; however it has always been the intent of Quanterix to first commercialize in the research space, as it is a quicker path to commercialization that provides us with revenues earlier," said Bradley. "By getting this instrument in the hands of researchers, we expect that they will be doing some of the work of discovering biomarkers that have clinical relevance and can benefit from greater sensitivity," he said. "So we will be multiplying the possibilities for diagnostic assays."
Quanterix is already developing assays in a number of areas, including oncology, neurology, and inflammatory disease. Together with partners at Johns Hopkins University and New York University, the company last year authored several papers detailing a new assay for measuring PSA on the Simoa platform.
The Simoa platform has been used in projects that resulted in a number of other publications. One study, pursued with researchers at the Mayo Clinic, relied on the Simoa platform to measureTNF-α and IL-6 concentrations in the plasma of patients with Crohn’s disease. Another paper, authored with researchers at the University of Gothenburg in Sweden, showcased the use of the Simoa to measure amyloid β levels in blood after an ischemic episode. In the paper, the authors suggested that hypoxia may play a role in the amyloidogenic process of Alzheimer's disease.
And, earlier this year, Quanterix announced two partnerships that could yield future tests: one with the Forsyth Institute and Beth Israel Deaconess Medical Center to validate low-abundance protein biomarkers that could be useful for identifying individuals with active tuberculosis disease; the other with In–Q–Tel to develop pathogen-detection assays that could test nucleic acids and proteins at the same time (BAN 1/10/2012).
Bradley said that Quanterix has not yet decided which assays it will select for eventual submission to the US Food and Drug Administration for clearance, though he acknowledged that the firm "has shown some clinical work on PSA and others that could well be the ones we choose to pursue."
But the firm's longer-term diagnostics strategy, beyond the first few tests it commercializes, may be to some degree in the hands of the researchers it hopes to reach with the launch of the HD-1 next year. "Imagine that someone finds an amazing application using Simoa to better diagnose or treat Alzheimer's, for instance," said Bradley. "That could form the basis for developing a novel diagnostic assay."