SAN DIEGO — Danish microRNA firm Exiqon this week detailed its plans to enter the molecular diagnostics market by the end of the year with a microRNA-screening assay for colorectal cancer recurrence.
The move comes a week after the company changed the name of its clinical laboratory diagnostics subsidiary from Oncotech to Exiqon Diagnostics.
Copenhagen-based Exiqon has been known as a vendor of miRNA-oriented research tools including microarrays, quantitative PCR, and in situ
hybridization kits. But the company bought Tustin, Calif.-based Oncotech earlier this year for $45 million with the goal of leveraging the testing firm’s tumor biobank and Clinical Laboratory Improvement Act-compliant laboratory to begin selling diagnostics (see BAN 11/27/2007
And the company had kept under wraps details on the indications its first tests would target and declined to speculate on which platform would ultimately be the primary vehicle for its tests.
The resulting speculation ended this week when Bill Ricketts, vice president of scientific operations at Exiqon Diagnostics, answered both questions during a presentation at IBC Life Sciences’ Discovery2Diagnostics meeting, held here this week.
According to Ricketts, Exiqon hopes to launch an in situ hybridization assay-based miRNA-based test designed to detect the likelihood of colorectal cancer recurrence. Ricketts told BioArray News that colorectal cancer is one of the first areas of interest to emerge since the Oncotech acquisition.
“We are looking to get a product out for colon cancer recurrence by the end of the year that will be sold through our lab to the medical oncologist to decide whether colon cancer has a likelihood of recurring earlier versus normal,” Ricketts said. “Then the oncologist would likely stratify that patient for more aggressive therapy. That’s the first test we are looking at this time.”
Ricketts said that Exiqon has made extensive use of its line of miRcury miRNA arrays in order to develop its tests, but that in situ hybridization kits are better vehicles than arrays for delivering the diagnostics to market.
“ISH is the most viable platform for reimbursement reasons,” Ricketts said. “It is a clinical, accepted lab procedure. You don’t have to go out there with a microarray and go forward with that.”
Instead, Ricketts said that Exiqon is more likely to continue using its arrays as screening tools in the diagnostic-development process. “Right now, it is a screening tool and we are trying to find those microRNAs that differ among drug phenotypes and then validate them in second sets using second technologies for in situ and get them out there,” he said.
Tool, Dx ‘Synergies'
Exiqon CEO Lars Kongsbak similarly told BioArray News this week that it was unlikely that the firm would use arrays as its primary diagnostics platform. “Eventually, I don’t think we’ll have that many array-based assays available through our CLIA lab,” Kongsbak said. “I think it will be in situ locked-nucleic acid- or qPCR -based assays. We see that quite often we only need one or a few miRNAs to be predictive.”
Still, Ricketts said that it was likely that Exiqon would offer some array-based tests in the future. Before becoming part of Exiqon, Oncotech specialized in cell-based, extreme drug-resistance assays for patients suffering from ovarian, lung, colon, pancreatic, and renal cancers. Now the firm plans to migrate some of those EDR tests to assays that use miRNA markers instead.
“ISH is the most viable platform for reimbursement reasons. It is a clinical, accepted lab procedure.”
“The plan has been to migrate the core part of the EDR business, which has been for ovarian, lung, and colon [cancer], over to an array platform with multiple variates,” Ricketts said.
While array-based tests would become available for those indications, the existing, cell-based EDR assay for the “foreseeable future” would remain available to support other indications, such as pancreatic cancer.
“As we get into drug response, the likelihood of it being a multiplex signature gets higher and higher,” said Ricketts. “Once you get to multiplexing, it’s either got to be something like Luminex’s [xMAP technology] or an array to do that test.”
Kongsbak said that Exiqon later this month will publish a prospective study of the EDR test to “support future molecular-based assays based on the resistance test.” He also said that the tests represent a market opportunity for the company.
“Only about 30 percent of chemotherapies prescribed today work efficiently in cancer patients, and many patients are resistant to the drugs,” Kongsbak said. “We have identified miRNA biomarkers that can tell when a tumor is resistant to a certain drug. This is one of the places where you can see the synergies between the tools business and the diagnostics business.”
It is unclear how competition in the nascent miRNA-diagnostics space will shake out.
Rosetta Genomics, for instance, has tests in its pipeline for predicting response to ovarian cancer treatment as well as colon cancer recurrence, but has not disclosed a launch date for either.
In the broader array-based molecular-diagnostics market, other firms targeting colorectal cancer recurrence include Northern Ireland’s Almac Diagnostics, which plans to seek US Food and Drug Administration 510(k) clearance for a gene-expression assay next year (see BAN 8/19/2008
In addition, Dutch diagnostics shop Agendia, which secured 510(k) clearance for its gene-expression-based MammaPrint test for breast cancer recurrence in 2007, is currently developing a test for colorectal cancer recurrence called ColoPrint (see BAN 9/4/2007
Exiqon also has made its subsidiary’s tumor bank available to pharmaceutical and biotech companies as well as academics, creating a third “pharma services” division within the company in addition to its life sciences tools and diagnostics units.
Kongsbak said that there is an “enormous need for pharma and biotech to get access to biological material,” and that the firm’s service offering has been “well received by pharma companies and I hope we can sign a few alliances going forward.”
According to Kongsbak, Exiqon’s path to profitability now rests on the success of its diagnostics business. In 2007, the company raised $80 million in an initial public offering on the Nordic Stock Exchange, which will continue to fund the company until diagnostics sales complement the firm’s existing revenues from its tools business (see BAN 6/26/2007
“The capital raised during [the] IPO is sufficient for us to become profitable by 2011,” Kongsbak said. “So we are in a unique position as a biotech; we don’t need more financing. The tool business and pharma business have a significant cash flow. When Exiqon Diagnostics begins generating revenue we will have a profitable business.”