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US Genomics and Lahey to Explore miRNA-based Urologic Cancer Biomarkers for Dx Development

US Genomics last week said it has formed a partnership with the Lahey Clinic to develop microRNA-based diagnostics for urologic cancers using the company’s molecular-detection and -analysis technologies.
The deal is US Genomics’ second in the miRNA space, coming about five months after it struck a similar arrangement with Rosetta Genomics to co-develop an miRNA-based lung cancer diagnostic (see RNAi News, 5/25/2006).
Unlike the Rosetta collaboration, however, under which “Rosetta retains the majority of responsibility for commercializing” resulting products, US Genomics “will own any of the content that gets developed as part of the [Lahey] collaboration.” It will also handle marketing activities in exchange for a “small royalty payable to Lahey,” Duncan Whitney, vice president of research and development at US Genomics, told RNAi News last week.
Through its partnership with Burlington, Mass.-based Lahey, US Genomics aims to leverage its Trilogy 2020 platform and Direct miRNA assay with the non-profit medical facility’s oncology know-how and resources.
“What we’re trying to do is look for microRNA markers that are indicators of disease progression for bladder cancer, as well as prostate cancer,” John Canepa, president and CEO of US Genomics, told RNAi News.
“Lahey has a longstanding history of being at the forefront of some research in a number of cancers [and has] done a nice job of collecting archives of tissue samples, as well as patient histories,” said Canepa. “So what we’re looking to do is tap into some of their expertise, not only with the samples but also their understanding of the diseases and disease management.”
In the Direct miRNA assay, two target-specific, fluorescent locked nucleic acid-DNA oligonucleotide probes are added to a biological sample, according to US Genomics, which licensed LNAs from Exiqon for use with the Trilogy platform in 2004. 
Each probe contains a different fluorescent tag — red, green, or blue labels — designed to hybridize to the selected target miRNA, the company said. The target molecule is the only molecule to hybridize with two distinctly colored probes.
Following hybridization, the sample is moved through a glass capillary as multiple lasers at different wavelengths excite the fluorescent probes. “The excited probes emit photons, which are counted and displayed in real time on the Trilogy 2020 software,” US Genomics said. “When red and green photons are counted simultaneously or coincidentally, the Trilogy 2020 analyzer recognizes and counts a single target molecule. By analyzing color coincidence, the Trilogy 2020 system accurately determines the number of target miRNA molecules in the sample.”
Details about the platform and assay were published earlier this year in Nature Methods.
Using the Trilogy and Direct technologies, US Genomics has already generated some preliminary data associating certain miRNAs with urologic cancers, particularly bladder cancer, Canepa said.
By working with Lahey, the company hopes to be able to further validate these findings while exploring the role of other miRNAs in the diseases, enabling it to commercialize new cancer diagnostics.
Just how US Genomics plans to commercialize an miRNA-based diagnostic is not yet clear, however, Canepa noted.
“We’re relatively early in the process [of developing the diagnostics] at this point,” he said. “We suspect that the [Lahey] project will go on probably over the next 12 months or so. During that time, we’ll begin to put some plans in place as to how we’re going to commercialize the signatures that come out” of the partnership.
Whitney added that the Rosetta partnership is also expected to run about 12 months, but that it is further along since it has been underway for about five months already.
Whitney said that US Genomics continues to “look to do more deals in the microRNA area,” especially with well-established firms.

“We don’t position our technology so much as a discovery tool like a microarray type of platform. However, some of the companies that do that type of work have seen the Trilogy platform [as having] some potential as a nice validation tool for any type of hits.”

“We believe the Trilogy instrument and the related assay are uniquely qualified to work in this area,” he said. “That is somewhat validated by the fact that people such as Rosetta … have come to us in order to do a deal and get access to that particular technology.
“I think that as more companies — maybe even some larger companies — begin to explore microRNAs as a potential diagnostic, hopefully they’ll … call us,” he added.
Canepa added that US Genomics expects it will limit its diagnostic efforts to cancer, at least in the near term. However, he noted that the Trilogy technology has shown potential in earlier-stage research, and as such the company would consider collaborations looking to apply the technology to miRNA discovery.
“One of the things that we have attracted some attention … on is in general validation of specific microRNA targets,” he said. “We don’t position our technology so much as a discovery tool like a microarray type of platform. However, some of the companies that do that type of work have seen the Trilogy platform [as having] some potential as a nice validation tool for any type of hits.”
Deals to use the technology in this “realm of R&D/basic research,” he noted, would certainly be of interest to US Genomics.

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