Exiqon last week announced a partnership with the University of Texas MD Anderson Cancer Center to cooperate on the discovery of microRNA biomarkers related to breast cancer.
The partnership will complement an ongoing breast-cancer study conducted by Exiqon both internally and externally, and is part of the Danish firm’s effort to develop a diagnostics business.
Under the collaboration, Copenhagen-based Exiqon will use its locked-nucleic acid nucleotide research products — including microarrays and quantitative PCR assays — to discover microRNA biomarkers in collaboration with MD Anderson’s Kleberg Center for Molecular Markers.
The collaboration is specifically focused on identifying miRNA expression signatures associated with the relapse and progression of breast cancer, and Exiqon aims to develop and validate diagnostic tools that could be used to guide patient management.
Gordon Mills, director the Kleberg Center, called the collaboration part of MD Anderson’s “efforts to change patient treatment” and to develop “microRNA-based molecular marker panels with different industry leaders in the microRNA field.”
According to Søren Morgenthaler Echwald, Exiqon’s vice president of business development, the partnership with MD Anderson is significant because it will give the company access to “very well characterized” breast cancer tissue samples and will draw on the center’s “expertise in the breast cancer area.”
Echwald told BioArray News this week that the company has already begun breast-cancer miRNA marker discovery work, both in its own lab and through a partnership with researchers at Herlev University Hospital, located outside of Copenhagen.
Moreover, the company currently has several different diagnostics programs underway. According to a company prospectus for investors released in February, in addition to breast cancer, potential indication areas include ovarian cancer, cancer of unknown primary, colon cancer, and lung cancer. The prospectus can be accessed here.
“It all comes down to the complexity of the test in terms of how many markers you need to assay to give a clinically relevant answer.”
To facilitate its entry into the diagnostics space, Exiqon acquired Oncotech, a Tustin, Calif.-based cancer testing company, for $45 million in stock earlier this year (see BAN 11/27/2008).
At the time of acquisition, Oncotech had a network of more than 7,000 oncologists and approximately 1,200 hospitals, including Cedars-Sinai, Memorial Sloan-Kettering, Johns Hopkins, UCLA, the Mayo Clinic, and Massachusetts General, using its test. The firm also operates a CLIA-approved laboratory, and has a human tumor bank, and an internally developed genomic R&D platform.
Echwald said that the “efforts of the two companies have been combined and have been pretty well integrated.” Therefore, Exiqon’s partnership with MD Anderson will look to utilize the entirety of the company’s infrastructure, including its labs in Denmark, California, and at its US subsidiary in Woburn, Mass. The company is also looking to hire US-based chief commercial and scientific officers to help develop the diagnostics business.
Exiqon hopes to have a diagnostic assay available through its CLIA lab in Tustin by the end of this year. Echwald declined to discuss for what indication the assay will be, though he said it will not be for breast cancer.
Another question is what platform Exiqon will use to deploy its tests. Echwald said that Exiqon hypothetically may end up using in situ hybridization, qPCR, and arrays in its diagnostics business, depending on the specific assay. The company currently sells a line of miRNA array products.
“Certainly for screening purposes, we still believe we have the best arrays in the world, and for identifying biomarkers that is a crucial step,” Echwald said. “What platform we use will depend on how many biomarkers you need to perform the test. It all comes down to the complexity of the test in terms of how many markers you need to assay to give a clinically relevant answer,” he said.
If Exiqon makes good on its promise to deliver a miRNA-based test to the market by year end, it may be the first company to use miRNA in array-based diagnostics. Though miRNA-marker discovery is relatively new — the first commercial miRNA microarrays only became available in 2005 — Echwald said that he believes neither the technology nor the molecule will stand in the way of market adoption.
“I think that in the end, the clinical data will speak for itself,” he said. “We are not worried that people will focus on the specific analyte. It is a question of can you show the data and is it clinically relevant.”