French diagnostics developer BioMérieux will move all of its array-based assays to other platforms, including a new system being co-developed with partner Biocartis.
BioMérieux, an Affymetrix diagnostics partner, currently uses the Affy platform "for the development of biomarkers," but "not for tests that we commercialize," spokesperson Koren Wolman-Tardy told BioArray News last week.
Still, Marcy l'Etoile-based BioMérieux has signed numerous agreements over the past decade to develop and market tests on the GeneChip platform. In 2004, for instance, the company used the technology to develop and launch a food-testing assay called FoodExpert-ID.
Additionally, the firm has in the past discussed developing an array-based prostate cancer-screening blood test designed to help doctors weigh the risks of performing tumorectomies (BAN 11/13/2007). Array-based tests for breast cancer, sepsis, and infectious diseases were also planned.
According to Wolman-Tardy, though, BioMérieux no longer aims to launch array-based tests. Instead, it recently decided to transfer all of its array-based assays in development to other systems.
"The tests in our pipeline will be developed to run on other platforms, including the molecular diagnostics platform we are co-developing with Biocartis," said Wolman-Tardy.
BioMérieux and Lausanne, Switzerland-based Biocartis penned an agreement last November to co-develop assays on Biocartis' DNA/RNA molecular diagnostics platform, which the companies plan to co-distribute next year.
The platform, which can perform complex tests on a "wide variety of samples," including pathology tests for cancer, "integrates all the steps of a multiplexed molecular assay, from sample-in to data-out, in a sealed disposable cartridge, which avoids any contamination risk." The platform is based on technology Biocartis acquired from Royal Philips Electronics in early 2010.
As part of its agreement with Biocartis, BioMérieux gained worldwide, exclusive rights to develop and commercialize microbiology and certain oncology and theranostic assays on the platform.
In exchange, BioMérieux bought a €9 million ($12.7 million) equity stake in Biocartis.
BioMérieux is not the first Affy partner to develop its tests on the GeneChip platform and then move them to another technology. Another is Epigenomics, which used the Affy platform for discovery work, but has since decided not to use it as a diagnostic platform.
Achim Plum, senior vice president of corporate development at the Berlin-based company, told BioArray News this month that Epigenomics originally developed an assay on the Affy platform for PITX2 DNA methylation, an "independent prognostic factor in prostate and breast cancer," but has since transferred the signature to a real-time PCR platform (BAN 3/15/2011).
Roger Schaller, senior director of business development at Affy, told BioArray News this week that not all of the firm's partners' tests will have the complex signatures that necessitate an array platform.
Still, he said that Biomerieux and Epigenomics have "demonstrated how the Affymetrix platform has been used for effective clinical signature discovery."
Schaller maintained that "signatures of moderate complexity between 30 and 2,000 genes are particularly well-suited to remain on array platform through validation and commercialization," noting the firm's platform has been cleared by the US Food and Drug Administration.
For lower-plex applications, Schaller said that Affy offers its QuantiGene platform, which "provides an alternative to qPCR with additional advantages, especially for [formalin-fixed, paraffin-embedded] samples."
The company also also works with many partners to "implement smaller array format for those test developers who want to preserve the integrity of their validation pipeline by staying on the same platform," Schaller added.
Around a dozen Affy partners are holding firm to their plan to develop and commercialize tests on the platform. One of them, Rotterdam, the Netherlands-based Skyline Diagnostics, won a CE-IVD mark this month for its AMLprofiler test for acute myeloid leukemia (BAN 3/15/2011).
"Skyline Diagnostics, Signature Diagnostics, Pathwork Diagnostics, among other PbA partners, are examples of how array-based technology is being used to develop complex tests and how we have a proven pathway to get there," said Schaller.
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