NEW YORK (GenomeWeb) – Protein assay firm BioScale said this week that it is changing its name to ProterixBio and shifting its focus from instrument development to diagnostics.
The company is now developing a proteomic test for chronic obstructive pulmonary disease (COPD), which it plans to launch in early 2018 out of its under-development CLIA laboratory, President and CEO Grace Colon told GenomeWeb.
Founded in 2002, ProterixBio launched its Vibe protein assay system in 2010. Based on the company's Acoustic Membrane Microparticle, or AMMP, technology, the system uses acoustical, rather than optical, detection for measuring proteins.
A capture agent like an antibody is attached to a resonating membrane and then exposed to a sample containing the analyte of interest. The analyte is captured by the affinity agent bound to the membrane, which adds mass to the membrane and in turn changes the frequency of the membrane's oscillations. The system detects and quantitates the analyte of interest by measuring these changes in frequency.
The Billerica, Massachusetts-based firm billed the system as superior to conventional immunoassays at measuring low-abundance proteins in complex matrices, but in the six years since it launched the device, it has struggled to gain customers.
Colon did not have the exact figure for platforms sold, but she said the technology had been used by "a couple dozen groups." That number includes both researchers who purchased a platform and those who accessed it through loans or projects done by ProterixBio in-house on their behalf.
The company has had more success during the same period with raising funding. In 2009 it raised $20.6 million in venture funding, followed by $25 million in 2010 and $18.8 million in 2013. One of the biggest investors was New York-based venture firm New Science Ventures, which Colon joined as a partner roughly two years ago. She was voted in as CEO a year ago, at which point, she said, she began the shift to the company's new diagnostics-based business plan.
The move to diagnostics emerged from work ProterixBio did with San Diego-based biopharma firm Carolus Therapeutics. The company was trying to look at inflammatory complexes involved in cardiovascular and pulmonary disease and, Colon said, "they looked at all kinds of platforms and we were the only platform where they were able to get the assay to work."
"That gave us the idea that, hey, if we can look at some of these novel inflammatory biomarkers there might be some interesting clinical applications there," she said. "And so we decided to kind of back off on the research-use-only strategy for now and really focus on diagnostics."
The company identified COPD as a promising area given the disease's chronic nature and the challenges involved in successfully managing it.
"You look at COPD and the fact that by 2020 this will be a $50 billion-a-year problem, and from all the payors and accountable care organizations and other folks we have been talking to it is clear this is a huge pain point for them," Colon said. "And part of it is getting the right information about a patient's stage and how to treat them and getting them better controlled so they are not going to the hospital that often."
She compared ProterixBio's aims to Crescendo Bioscience, which developed a proteomic test for managing rheumatoid arthritis. A rare success story among proteomic diagnostics firms, Crescendo was acquired by Myriad Genetics in 2014 for $270 million.
"We think [such a test] can be used for overall disease management, and ultimately we are hoping to kind of reduce exacerbations in the [COPD patient] population," Colon said. "The idea would be [patients] get tested when they go to the hospital and you see what their disease activity is. Then they would maybe be controlled in the hospital and then released and then they would take another test a few days later to make sure their score has gone down and they are more towards normal and controlled."
Thus far, ProterixBio has generated feasibility data showing that it can distinguish certain aspects of COPD using a group of around 25 to 30 protein markers, Colon said, adding that next it will be looking at these markers in several hundred patients including stable patients, frequently exacerbated patients, and controls.
Based on that work, she said, the company will develop an initial panel that it will take into development and validation with the goal of launching a test in early 2018. She added that the once the company has its initial panel in hand it plans to raise additional funds to commercialize it.
In the meantime, ProterixBio is also offering the markers to pharma companies interested in using them in their COPD drug development programs. It is currently in discussions with several drugmakers, Colon said. The company will also continue to support existing users of the Vibe platform, she said.
While ProterixBio struggled to make headway as an instrument vendor, the proteomic diagnostics business has not proved the most hospitable of places either, even for companies that have managed to bring tests to market. Acknowledging this fact, Colon said she saw reimbursement and adoption as the two main challenges facing the company's new model.
One key question, she said, is whether a test is truly addressing an unmet need and doing so in a way that will truly be useful to clinicians.
"I think that with a lot of the failures out there, maybe it was an exciting concept, some physicians got excited about it because it sounded cool and it was really something that kind of addressed an unmet need, but when you really looked at it, it wasn't really something people could actually use and make a decision," she said.
With this in mind, Colon said, the company is "actively working and talking to accountable care organizations and managed care companies to say, 'How can we begin at an early stage to pilot what we are doing with you and maybe get samples from you and work with your clinicians and see if this will actually make a difference in what they are doing?