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Two new partners for Life
CARLSBAD, Calif.—Life Technologies Corp. has entered into a master development agreement with Bristol-Myers Squibb Co. for current and future companion diagnostics projects. The agreement represents another step in Life Technologies' strategy to develop its diagnostic business through internal development, partnerships and selective acquisitions. The agreement covers an initial project for oncology and provides for a long- term partnership across a potentially broad range of Life Technologies' instrument platforms and a wide range of as yet unnamed therapeutic areas.
Life Technologies' metamorphosis began with two earlier steps—the acquisition of two genetic testing companies that gave Life Technologies a CLIA lab for expanding into the medical services business, and a portal that provided a physician- mediated network. Next up was the acquisition of Pinpoint Genomics and its early-stage non-small cell lung cancer test that can help doctors identify those early-stage patients at high risk for progression to late-stage disease. The Pervenio Lung RS molecular test has been documented to reliably identify early-stage lung cancer patients who are at high risk for mortality following surgery.
"Many lung cancer patients who are initially diagnosed with early-stage disease are dying from recurrences without having received any early post-operative intervention," says Dr. Michael Mann, associate professor of cardiothoracic surgery at the University of California, San Francisco, who co-developed the test with Dr. David Jablons, chief of general thoracic surgery at the university.
"The pharmaceutical industry is increasingly turning its focus to discovering and delivering targeted, personalized medications," says Ronnie Andrews, president of medical sciences at Life Technologies. "As more and more targeted drugs come onto the market in the next decade, there will be a growing need for diagnostics that can help predict which patients will benefit from which drugs."
For oncology alone, hundreds of agents are currently in clinical trials," Andrews notes, "and we see strong market opportunity in the robust expansion this will mean for the companion diagnostics space."
Life Technologies is uniquely positioned to provide pharma a flexible, cost- effective means to manage the evolution of the companion diagnostic assay through the drug development process, he adds.
A second multiyear partnership agreement will pair CollabRx's interpretive analytics with Life Technologies' cancer panels to be used in conjunction with its global cancer diagnostics development and its laboratory-developed test services business. The agreement represents a major step forward by CollabRx in providing laboratories and next-generation sequencing companies with meaningful insights into cancer.
"Molecular analysis, including genetic sequencing, is increasingly becoming an important part of the clinical management of cancer patients," says James Karis, co-CEO of CollabRx.
"However, the sheer volume and complexity of genetic data that is being produced, particularly in the course of therapy development, is outpacing the ability of practicing physicians to stay current and, more importantly, understand how to apply this genetic data in treating their patients."
Life Technologies will use CollabRx's content and technology to pair the results of broad molecular profiling panels it develops with associated clinically relevant and dynamically updated knowledge on clinical trials, drugs, biologics and other information relevant for cancer treatment planning. This knowledge is supported by CollabRx's large and growing network of over 50 leading clinical practitioners in the United States. While CollabRx and its advisors do not provide specific treatment recommendations, this clinically relevant knowledge is a key part of the "context engine" for informing healthcare decision-making.
"It's critical to contextualize the results of complex cancer panels to make them useful for physicians," says Andrews. "CollabRx has pioneered the development of a scalable platform and process to provide actionable, accessible and credible knowledge at the point of care to aid physicians in developing a cancer treatment plan based on tumor molecular profiles. We are excited to include this key capability with our molecular diagnostic tests."
Life Tech, VelaDx to develop in- vitro Dx tests
CARLSBAD, Calif.—Life Technologies Corp. and VelaDx have entered into a license and supply agreement that will give VelaDx rights to develop and market next-generation sequencing-based, in-vitro diagnostic tests on the Ion Personal Genome Machine (PGM) platform. VelaDx will seek approvals from global regulatory authorities for clinical diagnostic tests in oncology and infectious disease.
According to the companies' announcement, Vela chose the Ion PGM System because of its speed, simplicity and flexibility, and because it is complementary to Vela's Sentosa workflow and its menu of qPCR assay kits. Both Ion's PGM and Vela's Sentosa systems can operate on a menu of single-indication tests or multiple-indication panels that can easily be implemented in virtually any laboratory. A seamless, bidirectional data communication with laboratory information systems between the Ion PGM and Sentosa systems will maintain the accuracy of data and improve the efficiency of the laboratory workflow, the companies say.