French diagnostics firm Ipsogen said this week that it has signed an agreement with DNAVision, a Belgian pharmacogenomics lab that caters to biotech and pharmaceutical customers, to provide a series of array-based microarray tests for breast cancer that it plans to launch next year.
The agreement follows Ipsogen’s announcement last week that it has become a Powered by Affymetrix partner company, which gives it the right to market its breast cancer tests on Affy’s GeneChip microarray platform. Moreover, both agreements will allow Ipsogen to focus more on test development and sales and marketing activities as the company now considers its hardware needs to be met, according to a company official.
Jean-Marc Le Doussal, head of Ipsogen’s breast cancer program, told BioArray News this week that both deals are significant for the company and will ultimately work to its advantage in the competitive market for array-based breast cancer tests, which now includes rivals such as Almac Diagnostics, Agendia, and DiaGenic.
“This is an important deal for the company because we get all our hardware for sample processing,” Le Doussal said of the agreement with DNAVision. “With Affy and DNAVision we have access to all the hardware needed for delivering the tests,” he said. “Now we can really focus on software, marketing the test themselves, developing new signatures, et cetera.”
However, Ipsogen is remaining quiet on the specific kinds of tests it plans to introduce. Neither of the statements from the firm regarding the DNAVision and Affymetrix agreements discussed the kinds of tests the market should expect, and Le Doussal was similarly mum when asked about the nature of the tests in Ipsogen’s pipeline.
“What I can say now is that Ipsogen has a comprehensive pipeline of complementary tests to meet the needs of pathologists and oncologists. What they need is reliable classifications that apply to certain treatments,” he said. Le Doussal added that the tests should become available through DNAVision in early 2008.
“DNAVision will be the only lab because they have the best quality system you can find for microarray expression and they have been part of the Microarray Quality Control project and several other projects. We prefer to rely on a real centralized lab like this for our tests,” said Le Doussal.
The company also plans to pursue a CE Marking and US Food and Drug Administration clearance for the breast cancer tests “ within two or three years,” said Le Doussal.
Ipsogen was founded in Marseille in 1999 with technology licensed from the University of Marseille. Le Doussal said the firm originally used a cDNA platform for its breast cancer biomarker discovery work. It then became an Affymetrix service provider in 2004, a decision that helped influence its later choice to migrate the breast cancer biomarkers from the cDNA platform to GeneChips. The move was also supported by the FDA 510(k) clearance of Roche’s AmpliChip, also based on the GeneChip platform, at the end of that year.
“The decision was made to migrate diagnostics to a commercial platform because they appeared more reliable in 2005 ... obviously Affy appeared to be the most advanced, certainly in the diagnostic setting. So it was quite logical, and we knew about the platform from the service,” he said.
“Now we can really focus on software, marketing the test themselves, developing new signatures, et cetera.”
Still, Le Doussal said those years of cDNA work have been productive, yielding a hybrid in-house/out-licensing model for obtaining content for test development. Ipsogen’s current pipeline of breast cancer tests derive from “ a mix of in-house and licensed IP” he said.
Le Doussal said that the in-house IP was developed in a collaboration with the cancer hospital Institut Paoli-Calmettes in Marseille as well as several cancer hospitals in France that provided access to “hundreds of samples of breast cancer patients treated with chemotherapy.”
He said the company is developing several tests to monitor the progress of breast cancer, which could presumably range from early-stage diagnostics to recurrence prognostics. Whatever the ultimate output, Le Doussal said that the DNAVision and Affy agreements will give it an edge in terms of flexibility and reaction to market needs.
“Using test-independent hardware, our advantage is that we can rapidly adapt our offer to scientific findings and customer needs,” he said. He also said that Ipsogen’s suite of possible tests could be more attractive in the marketplace than a diagnostic like Agendia’s MammaPrint for breast cancer recurrence because Ipsogen could offer a “comprehensive solution, not only one test.”
While Ipsogen has focused on breast cancer research since it was founded, it has also developed a line of leukemia monitoring assays that use its in-house cDNA array platform. According to Le Doussal, the company will most likely not migrate the leukemia assays over to the Affy platform due to its current focus on breast cancer.
“Leukemia is quite a niche where Ipsogen has a leadership, mostly with tests that allow treatment monitoring,” he said. “Now we are really focusing on breast cancer. Of course we don’t rule out looking into other areas, but for now breast cancer is our main priority.”