NEW YORK (GenomeWeb) – Exosome Diagnostics announced last week that it has developed its first ever lab instrument, a label-free, automated system for detection of exosomal proteins directly from blood or other body fluids.
The company has been working on technology to assay a variety of molecular targets — DNA, RNA, and also proteins — from liquid samples for years, but this is the first time it has developed a standalone device.
Exosome Dx believes the new system will drive significant incremental revenues in 2017, but the move does not signal a shift away from diagnostics development in favor of tools manufacturing, President and CEO John Boyce told GenomeWeb.
Instead, Boyce said, the new system will help drive forward the clinical and companion diagnostic partnerships that continue to be Exosome Dx's central focus.
Though he declined to provide much detail on the technology behind the new instrument, Boyce said that the analysis portion is something Exosome licensed from an academic group.
"We already had this robust chemistry and technology, and we tried to find a commercially available platform we could employ this on, but we weren't able to … without losing power of our chemistry. So we looked around and found one technology that had a lot of promise in terms of being the analytical portion of this," Boyce said.
The device does not require any upfront sample prep, and the minimum input is 10 microliters. The system uses a label-free detection method with high sensitivity (more than 100x higher than ELISA, according to the company), resulting in a four-minute run time.
According to Boyce, the main advantage of the platform compared to other methods for analyzing proteins in blood and other body fluids is that it allows detection of exosomal proteins separately from the bulk of circulating proteins that can hopelessly confound other methods.
Analysis of proteins in plasma, especially low-abundance proteins, is difficult because a target signal can be drowned out by the vast background of circulating proteins.
The company's technology not only enables analysis of exosomal proteins away from this background noise, but also allows for the isolation of disease-specific exosomes by targeting specific surface markers that link a particular set of vesicles to their origin in a tumor.
Boyce said that interest in Exosome Dx's new instrument has been very strong, especially among new or existing pharmaceutical partners.
According to the company, exosomal proteins hold promise as biomarkers for things like immuno-oncology drugs, with signatures in ovarian cancer and other diseases already being published in peer-reviewed journals.
Between acceleration of the company's in-house testing business with the launch of its urine-based prostate cancer test last year, and the space and energy it now needs to devote to its new protein instrument, Boyce said Exosome Dx has outgrown its current facilities in [location] and is now planning to move to a new space about three times the size.
Boyce said that the company has been rolling out the new instrument in a relatively narrow fashion — with select early access users whom it has not yet named. The company plans to develop both static panels for the system, and to provide more custom target kits. Boyce told GenomeWeb that the plan is to have three basic configurations: one version with 10 targets, one with 100, and one with 1,000.
"We can easily customize these depending on what a user wants," he said, "And we're now in the process of developing the larger chip to accommodate, basically the most common pathways in oncology."
Boyce also stressed that Exosome Dx has developed its device with future regulatory considerations in mind. Use of the instrument in current and upcoming pharma partnerships portends eventual companion diagnostic development, which would require the instrument to garner approval by appropriate authorities like the US Food and Drug Administration.
"We had our head of regulatory, who is also an engineer, run this project, so we could design a system that is directly amenable to the clinic," Boyce said.
Exosome Dx is not alone in its interest in analysis of molecular signals in and on exosomes.
Though the company hasn't yet disclosed the source of the analytical technology of its new platform, it likely had a number of technologies to choose from, as isolation and analysis of circulating biomarkers has become an area of intense interest.
For example, a group from Massachusetts General Hospital and Harvard Medical School described a platform for label-free, high-throughput, quantitative analysis of exosomes using transmission surface plasmon resonance through periodic nanohole arrays in Nature in 2014.
More recently, a team from the University of Queensland shared its own approach for quantification of clinically relevant exosomes isolated from patient serum also using a surface plasmon resonance platform.
A team of Swedish researchers recently received $3.3 million to develop a new nanotechnology platform for detecting blood-borne DNA or protein biomarkers in exosomes from lung and breast cancer patients.
Though others have been investigating exosome-based diagnostics, Boyce said that Exosome Dx is confident that its proprietary methodology will help it keep a leadership position in the field. For example, he said, the company has had experiences with pharma partners who had been trying to assay exosomal biomarkers to stratify patients in their drug development trials, but without success.
He further claimed that Exosome Dx, using its own chemistries and technologies, has been able to come in and draw out a useful signal where internal programs failed.
Pharma partners that the company has publicly named include Amgen and Takeda. But Boyce said that Exosome is in the midst of finalizing agreements with about seven others.
Proteins, meanwhile, are just one arm of Exosome's ambitions.Its two existing clinical tests — the newer ExoDx Prostate(IntelliScore), as well as its ExoDx Lung(ALK), ExoDx Lung(T790M), and ExoDx Lung(EGFR) — analyze either extracellular RNA or DNA.
According to Boyce, the new instrument has potential to also support exosome-based nucleic acid detection. That would require much more development though, and is not something that the company expects to tackle any time soon, he said.
He added that Exosome has plans to launch additional diagnostic tests next year, but declined to provide additional details.