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Exiqon Inks $2.1M Grant to Develop NGS-based Cancer Dx and Prognostic Tests

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Danish life sciences and diagnostics company Exiqon plans to use a DKK 12 million ($2.1 million), five-year grant from the Danish Technology Foundation to develop next-generation sequencing and bioinformatics capabilities for precision medicine.

Peter Mouritzen, the company's vice president of research and development, told Clinical Sequencing News that the company will be collaborating with partners at the Technical University of Denmark, Intomics, Vejle Hospital, and the University of Southern Denmark to develop diagnostic and prognostic tests for colorectal cancer patients. The company plans to invest in benchtop sequencing platforms, although Mouritzen said the firm has not yet decided which company's machines it would purchase.

"A number of these benchtop instruments are in the process of going through [US Food and Drug Administration] clearance," Mouritzen said. "So any test developed on the platform would have an easier way through regulatory approval processes."

Exiqon's focus is primarily microRNA, and it develops products for microRNA research, including kits that can purify RNA from low-abundant samples like blood and urine. Additionally, the firm has developed proprietary technology dubbed locked nucleic acid, or LNA, which are RNA analogs the company uses to design LNA oligonucleotides that are very sensitive and enable detection from challenging clinical samples.

Because of its expertise in these areas, Mouritzen said the sequencing project would initially focus on small RNA sequencing and then move into targeted gene panels. Mouritzen said the company will make use of its LNA technology for the target enrichment strategy.

Mouritzen said the company will be looking to develop a next-gen sequencing core facility under the grant, and also to incorporate sequencing services within its services business, which currently performs microRNA profiling. Through that business the company has experience in handling "precious and irreplaceable samples for both pharmaceutical and academic customers," Mouritzen said, "so we think this is an ideal setting for [next-gen sequencing]," and will enable the company to offer sequencing services to its customers as well.

"For Exiqon, it's a very interesting scope in pursuing our already existing diagnostic initiatives on various cancers and also to establish an NGS service for customers outside of Exiqon," he said.

The first year and a half will be spent setting up and establishing the technology within Exqion, Mouritzen said. And over the next three and a half years, the company will release results as they are available.

"The project is really looking for biomarkers," Mouritzen said. Biomarkers that "predict the occurrence of colorectal cancer and predict response to medicine," he said, in order to "optimize treatment to benefit the patient, reduce costs, and eliminate side effects.

Vejle Hospital, which hosts one of the largest cancer centers in Denmark, will supply biobanked samples from several cohorts of 200 to 1,000 patients, including both formalin-fixed paraffin embedded tissue and blood samples. The study will include both retrospective and prospective arms, Mouritzen said.

Initially, studies will focus on microRNA sequencing to look for biomarkers that predict treatment response and recurrence. While microRNAs are "newer biomarkers," they have "become quite established as a biomarker in cancer and other diseases," Mouritzen said. Additionally, Exiqon will incorporate panels of genes that have been identified as important by the university collaborators.

Exiqon will evaluate samples from various stages of colorectal cancer, including at the initial diagnosis, post-treatment, and later stages. Additionally, it will sequence patients at different times throughout the treatment course to look for changes.

Results will not be returned to patients, said Mouritzen, since the project is mostly focused on identifying the biomarkers that could be used in future tests.

The tests that are eventually developed from the project may run on next-gen sequencing platforms or another technology platform. "Time will show," said Mouritzen. "But the pace that NGS is being taken up into the clinic … I think it's very likely that [the tests] will be based on an NGS platform."

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