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Lilly, PrimeraDx break the ICE
MANSFIELD, Mass.— With the goal of bringing the much-ballyhooed concept of personalized medicine to the clinic, global pharma Eli Lilly & Co. has entered into a multi-year quest to develop diagnostic products with PrimeraDx, a privately held molecular diagnostics company located here.
Under the terms of this agreement, announced June 26, the two companies will collaborate on the development of multiplex assays on PrimeraDx 's clinical platform, the Integrated Capillary Electrophoresis Multiplex (ICEPlex) System. Financial terms of the collaboration were not disclosed.
ICEPlex combines polymerase chain reaction (PCR) with capillary electrophoresis to create a benchtop instrument with the ability to deliver highly multiplexed and quantitative information to the clinic. Users can easily design very complex multimodal assays that test for disparate target types, like single-nucleotide polymorphisms (SNPs), expression biomarkers, microRNAs and fusion genes.
According to PrimeraDx, a genotyping test for 20 mutations would require five tubes in a conventional qPCR system, whereas ICEPlex can perform the entire reaction in a single reaction tube. This, along with probe-free amplification chemistry, allows for simpler assays that are easier to develop, validate, manufacture and present to regulators, the company says.
PrimeraDx intends to sell the system in an "Open Platform Mode" to clinical labs and to collaborate with pharmaceutical companies to develop high-value companion and enabling diagnostic products.
"We have great expectations of our collaboration with PrimeraDx," said Dr. Andrew Schade, senior director of Lilly's clinical diagnostics laboratory, in a statement announcing the collaboration. "The unique ability of the ICEPlex System to combine multiple DNA and RNA biomarkers into a single multiplex assay could prove invaluable in our drive to develop companion diagnostics for crucial assets in our clinical pipeline."
The collaboration will initially focus on developing companion diagnostics for oncology, with plans to apply the research across other therapeutic areas later, Schade noted.
Lilly has signed several similar deals—with Almac, Avid Radiopharmaceuticals and Qiagen, to name just a few—in recent years as the pharma looks to bolster its diagnostics capabilities.
"A big part of the company's innovation strategy is providing improved outcomes for individual patients, which can be achieved through tailored therapies," Tiffany Olson, vice president of diagnostics at the pharma, told ddn in 2009.
Olson noted that companion diagnostics can have a great impact on current cancer treatment trends, and building Lilly's diagnostics capability will allow patients, payers and prescribers to know, through diagnostics tools such as blood tests, biopsies or imaging, which characteristics or biomarkers exist in which patients—and in turn, which Lilly medicines are likely to work in which patients, and which are not.
"This offers many advantages from earlier understanding of efficacy and target populations to potentially lower development costs and improve outcomes for individual patients," she said. "We see opportunities for companion diagnostics across approximately 40 percent of our portfolio of pipeline molecules, including many in cancer."
Dr. Matt McManus, president and CEO of PrimeraDx, said the partnership is a step toward PrimeraDx's achievement of its goal of "bringing personalized medicine to the clinic and being the leader in the high-value companion diagnostics space."
"These programs are a tremendous validation of our technology and its utility in the development of complex tests to better diagnose and treat patients. We are very excited about collaborating with Lilly on these important programs," McManus added.