CARLSBAD, Calif.—Life Technologies Corp. has entered into amaster development agreement with Bristol-Myers Squibb Co. for current andfuture companion diagnostics projects. The agreement represents another step inLife Technologies' strategy to develop its diagnostic business through internaldevelopment, partnerships and selective acquisitions. The agreement covers aninitial project for oncology and provides for a long-term partnership across apotentially broad range of Life Technologies' instrument platforms and a widerange of as yet unnamed therapeutic areas.
Life Technologies' metamorphosis began with two earliersteps—the acquisition of two genetic testing companies that gave LifeTechnologies a CLIA lab for expanding into the medical services business, and aportal that provided a physician-mediated network. Next up was the acquisitionof Pinpoint Genomics and its early-stage non-small cell lung cancer test thatcan help doctors identify those early-stage patients at high risk forprogression to late-stage disease. The Pervenio Lung RS molecular test has beendocumented to reliably identify early-stage lung cancer patients who are athigh risk for mortality following surgery.
"Many lung cancer patients who are initially diagnosed withearly-stage disease are dying from recurrences without having received anyearly post-operative intervention," says Dr. Michael Mann, associate professorof cardiothoracic surgery at the University of California, San Francisco, whoco-developed the test with Dr. David Jablons, chief of general thoracic surgeryat the university.
"The pharmaceutical industry is increasingly turning itsfocus to discovering and delivering targeted, personalized medications," saysRonnie Andrews, president of medical sciences at Life Technologies. "As moreand more targeted drugs come onto the market in the next decade, there will bea growing need for diagnostics that can help predict which patients willbenefit from which drugs."
For oncology alone, hundreds of agents are currently inclinical trials," Andrews notes, "and we see strong market opportunity in therobust expansion this will mean for the companion diagnostics space."
Life Technologies is uniquely positioned to provide pharma aflexible, cost-effective means to manage the evolution of the companiondiagnostic assay through the drug development process, he adds.
A second multiyear partnership agreement will pairCollabRx's interpretive analytics with Life Technologies' cancer panels to beused in conjunction with its global cancer diagnostics development and itslaboratory-developed test services business. The agreement represents a majorstep forward by CollabRx in providing laboratories and next-generationsequencing companies with meaningful insights into cancer.
"Molecular analysis,including genetic sequencing, is increasingly becoming an important part of theclinical management of cancer patients," says James Karis, co-CEO of CollabRx.
"However, the sheer volume and complexity of genetic datathat is being produced, particularly in the course of therapy development, is outpacingthe 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 technologyto pair the results of broad molecular profiling panels it develops withassociated clinically relevant and dynamically updated knowledge on clinicaltrials, drugs, biologics and other information relevant for cancer treatmentplanning. This knowledge is supported by CollabRx's large and growing networkof over 50 leading clinical practitioners in the United States. While CollabRxand its advisors do not provide specific treatment recommendations, thisclinically relevant knowledge is a key part of the "context engine" forinforming healthcare decision-making.
"It's critical to contextualize the results of complexcancer panels to make them useful for physicians," says Andrews. "CollabRx haspioneered the development of a scalable platform and process to provideactionable, accessible and credible knowledge at the point of care to aidphysicians in developing a cancer treatment plan based on tumor molecularprofiles. We are excited to include this key capability with our moleculardiagnostic tests."
Life Tech, VelaDx to develop in-vitro Dx tests
CARLSBAD, Calif.—Life Technologies Corp. and VelaDx haveentered into a license and supply agreement that will give VelaDx rights todevelop 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 authoritiesfor clinical diagnostic tests in oncology and infectious disease.
According to the companies' announcement, Vela chose the IonPGM System because of its speed, simplicity and flexibility, and because it iscomplementary to Vela's Sentosa workflow and its menu of qPCR assay kits. BothIon's PGM and Vela's Sentosa systems can operate on a menu of single-indicationtests or multiple-indication panels that can easily be implemented in virtuallyany laboratory. A seamless, bidirectional data communication with laboratoryinformation systems between the Ion PGM and Sentosa systems will maintain theaccuracy of data and improve the efficiency of the laboratory workflow, thecompanies say.