Biocartis, Janssen to develop assays for MDx system
LAUSANNE, Switzerland— Diagnostic technology platform developer Biocartis announced Jan. 10 that it will work with two Johnson & Johnson family companies—Janssen Pharmaceutica NV and Ortho-Clinical Diagnostics Inc.—to co-develop assays on Biocartis' fully integrated molecular diagnostics (MDx) system.
Working out of the EPFL Science Park in Lausanne, Switzerland, and at the High Tech Campus in Eindhoven, The Netherlands, Biocartis is developing two diagnostic platforms. The company acquired the first platform, a molecular diagnostics platform, from Philips in early 2010. The platform fully integrates any sample preparation of nucleic acids, amplification, detection and the generation of a result without user intervention, and has been designed for applications in a wide range of patient sample testing, including oncology and infectious diseases. Biocartis' second platform is a multiplex detection platform that includes encoded microcarriers, a micofluidic cartridge and an instrument for low- to high-multiplexing detection of biomarkers.
Under this new agreement, Janssen—which took an equity stake in Biocartis last year—will have worldwide exclusive rights to develop and commercialize assays on Biocartis' MDx platform in the fields of neurological disease and certain viral infectious diseases.
According to Biocartis, the platform now fully integrates all the steps of a multiplexed molecular assay, from sample-in to data-out, in a sealed, single-use disposable cartridge, which avoids any contamination risk. Providing rapid results, the system is able to perform complex tests on a wide variety of samples, including oncology assays on tissue. The platform does not require molecular biology experience or infrastructure with highly skilled technicians, and involves only one to two minutes of hands-on time. Adapted to both small and large labs, the platform is fully scalable and allows random access use, Biocartis says.
Biocartis says it intends to bring this system to market through a series of collaborations that will enable to company to create a broad menu of assays covering a wide range of applications. The Janssen agreement is expected to give the Biocartis platform an exclusive line of assays in the fields of neurological disease and certain viral infectious diseases. For the latter field, Biocartis and Janssen may co-develop and commercialize assays. Biocartis will manufacture the instruments and the diagnostic assays.
"Biocartis will be responsible for completing the development of its MDx platform, and Janssen will be responsible for development and regulatory approval of the licensed assays," explains Dr. Erik Vossenaar, director of business development at Biocartis. "Biocartis will produce instruments and assay cartridges. The instruments will be distributed by Biocartis, and the assay cartridges will be distributed by Janssen. For a subset of the assays in the viral infectious field, Janssen does not have worldwide commercialization rights, but Biocartis retains commercialization rights in certain geographies. For this subset of assays, both parties may choose to co-develop the assays and commercialize it in its respective geography."
From the deal, Biocartis will earn upfront and milestone payments and royalties on future sales. Specific financial details were not disclosed.
The Janssen deal is Biocartis' second MDx collaboration. It entered into a deal with bioMerieux in November that gives bioMerieux worldwide rights to develop and commercialize microbiology assays on Biocartis' platform, as well access to the platform for certain oncology and theranostics assays.
"The partnership with Janssen could be seen as a broader collaboration with other J&J affiliates," says Vossenaar. "Biocartis will enter the market through a series of partnerships that will help to develop a broad range of relevant clinical applications on our innovative platform in a relatively short term. Both J&J and its affiliates and bioMÈrieux have significantly more assay development power and marketing power than Biocartis. Both partners, and any potential future partner, will develop complementary, non-overlapping menus of assays—hence, they are not in competition. A unique element of our business model is that instruments distributed by our partners are still accessible for assays commercialized by our other partners. Hence, all partners can leverage the entire installed base of Biocartis MDx instruments."
Founded in 2007, Biocartis has raised nearly $65.6 million in capital since 2009 through a syndicate of investors.