MARCY L'ETOILE, France—bioMérieux and Biocartis announced in early November that they have entered into a strategic agreement to co-develop assays on Biocartis' fully integrated molecular diagnostics system, which the two companies will co-distribute starting in 2012.
Under the agreement, bioMérieux will have worldwide exclusive rights to develop and commercialize microbiology assays on the platform. It will also have access to the platform for certain oncology and theranostics assays.
Biocartis will receive upfront and milestone payments as well as royalties on future sales. bioMérieux has taken an $11.8 million equity stake in Biocartis. In connection with the equity stake, bioMérieux has the right to designate one director for election to the board and as a result, the company's CEO, Stéphane Bancel, will become a Biocartis board member. No additional financial details of the transaction were made available.
Biocartis has spent most of this year successfully developing its molecular diagnostics platform, which was acquired from Philips earlier in 2010. The platform now fully 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.
"Biocartis and bioMérieux initiated their discussions shortly after the acquisition of the molecular diagnostics assets from Philips earlier this year," says Erik Vossenaar, director of business development for Biocartis. "The partnership was formalized on Nov. 4."
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 highly skilled technicians, and can produce results with only a minute or two of hands-on time.
"It's the first time for Biocartis to establish a relationship with bioMérieux," says Vossenaar. "Biocartis is developing a fully integrated molecular diagnostics platform that offers unsurpassed ease-of-use and is capable of processing a wide range of molecular diagnostic assays from a variety of sample types. Due to its modular architecture, the system is scalable towards the needs of both small and larger labs. bioMÈrieux has recognized the value of the Biocartis platform. Especially in microbiology—bioMérieux is the world market leader in this field—where there is a need for systems that enable rapid diagnostics results and for availability around the clock."
According to Vossenaar, the agreement has been hammered out to provide for both production and distribution of the partnership's products.
"Biocartis will manufacture the instruments and assays," he says, "The assays will be commercialized by bioMérieux, leveraging bioMérieux's leading position in the market and the instruments will be co-distributed by both parties."
Pascale Merle, external communications manager for bioMérieux, agrees that the partnership will bring together complementary businesses.
"The collaboration will leverage bioMérieux's expertise in assay development and its menu of assays for healthcare-associated infections (HAIs) and sepsis, currently available in other product ranges, and Biocartis' expertise in molecular diagnostics platform development," Merle says.
After additional development, it is expected that the system will be put to work in the near future, and further developed after that.
"HAI assays should be available when the system is launched in 2012, and oncology and theranostics assays should be launched in 2015," says Merle. "There are specific milestones; those milestones and their dates are not yet communicated."
Both sides agree that the molecular diagnostics market in microbiology is just getting started. As such, the partnership can realize early on that the technology can be used in a flexible manner, depending on the needs of the patient and size or location of the medical facility.
"The molecular diagnostics market is still in its early days for microbiology, except for sexually transmitted diseases," explains Merle. "There is still an unmet need for rapid microbiology tests on a simple, integrated system that can enable testing where it needs to be done, including satellite labs and possibly emerging countries. The unique markers that will be offered on the system and its multiplexing capabilities are additional differentiating features."
Molecular diagnostics assays are, in general, very complex to perform, adds Vossenaar. They require highly trained technicians and dedicated laboratory environments (such as separated pre- and post-amplification rooms). Most diagnostic platforms currently on the market are either high-throughput batch-based systems or research-type equipment, he says.
"Due to the complexity and the high investments needed, less than 10 percent of the hospitals are currently equipped to perform molecular diagnostics tests in-house," he explains. "The combination of Biocartis' innovative molecular diagnostics platform and bioMérieux's line of assays will enable all hospitals, small and large, to perform a range of molecular diagnostics assays in-house and in time."
Both sides of the collaboration agree that each brings something to the table that helps the other realize important business and medical objectives.
According to Vossenar, his company intends to enter the market through a series of exclusive partnerships, thereby enabling a broad menu of assays to be provided to the end-users.
Speaking for bioMérieux, Bancel says that this platform is a linchpin to international growth. "Molecular biology is an important technology for strengthening our global leadership in microbiology and becoming a key theranostics partner for pharmaceutical companies.
"By gaining access to such an innovative, fully integrated platform, bioMérieux achieves a significant milestone in our growth strategy for the next decade," Bancel adds.
Based at the EPFL Science Park in Lausanne, Switzerland and at the High Tech Campus in Eindhoven, the Netherlands, Biocartis is a privately owned biotech company that was founded in 2007 and engages in the development of novel diagnostics technology platforms for low to highly multiplexed detection of molecular-based biomarkers. A new research and development and manufacturing center is being established in Flanders, Belgium.
The company has raised significant capital since 2009 through a syndicate of investors that contains some of Europe's most successful biotech entrepreneurs, including Aescap Venture Management, Advent Venture Partners, Biovest, and Debiopharm Group, as well as KBC Private Equity and Johnson & Johnson Development Corp.
A world leader in the field of in vitro diagnostics for more than 45 years, bioMérieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. In 2009, revenues reached $1.6 billion with 85 percent of sales outside of France. bioMérieux provides diagnostic solutions that determine the source of disease and contamination. Products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
