Lilly, PrimeraDx break the ICE

MANSFIELD, Mass.— With the goal of bringing themuch-ballyhooed concept of personalized medicine to the clinic, global pharmaEli Lilly & Co. has entered into a multi-year quest to develop diagnosticproducts with PrimeraDx, a privately held molecular diagnostics company locatedhere.

Under the terms of this agreement, announced June 26, thetwo companies will collaborate on the development of multiplex assays onPrimeraDx's clinical platform, the Integrated Capillary ElectrophoresisMultiplex (ICEPlex) System. Financial terms of the collaboration were notdisclosed.

ICEPlex combines polymerase chain reaction (PCR) withcapillary electrophoresis to create a benchtop instrument with the ability todeliver highly multiplexed and quantitative information to the clinic. Userscan easily design very complex multimodal assays that test for disparate targettypes, like single-nucleotide polymorphisms (SNPs), expression biomarkers,microRNAs and fusion genes.

According to PrimeraDx, a genotyping test for 20 mutationswould require five tubes in a conventional qPCR system, whereas ICEPlex canperform the entire reaction in a single reaction tube. This, along withprobe-free amplification chemistry, allows for simpler assays that are easierto develop, validate, manufacture and present to regulators, the company says.

PrimeraDx intends to sell the system in an "Open PlatformMode" to clinical labs and to collaborate with pharmaceutical companies todevelop high-value companion and enabling diagnostic products.

"We have great expectations of our collaboration withPrimeraDx," said Dr. Andrew Schade, senior director of Lilly's clinicaldiagnostics laboratory, in a statement announcing the collaboration. "Theunique ability of the ICEPlex System to combine multiple DNA and RNA biomarkersinto a single multiplex assay could prove invaluable in our drive to developcompanion diagnostics for crucial assets in our clinical pipeline."

The collaboration will initially focus on developingcompanion diagnostics for oncology, with plans to apply the research acrossother therapeutic areas later, Schade noted.

Lilly has signed several similar deals—with Almac, AvidRadiopharmaceuticals and Qiagen, to name just a few—in recent years as thepharma looks to bolster its diagnostics capabilities.

"A big part of the company's innovation strategy isproviding improved outcomes for individual patients, which can be achievedthrough tailored therapies," Tiffany Olson, vice president of diagnostics atthe pharma, told ddn in 2009.

Olson noted that companion diagnostics can have a greatimpact on current cancer treatment trends, and building Lilly's diagnosticscapability will allow patients, payers and prescribers to know, throughdiagnostics tools such as blood tests, biopsies or imaging, whichcharacteristics or biomarkers exist in which patients—and in turn, which Lillymedicines are likely to work in which patients, and which are not.

"This offers many advantages from earlier understanding ofefficacy and target populations to potentially lower development costs andimprove outcomes for individual patients," she said. "We see opportunities forcompanion diagnostics across approximately 40 percent of our portfolio ofpipeline molecules, including many in cancer."

Dr. Matt McManus, president and CEO of PrimeraDx, said thepartnership is a step toward PrimeraDx's achievement of its goal of "bringingpersonalized medicine to the clinic and being the leader in the high-valuecompanion diagnostics space."

"These programs are a tremendous validation of ourtechnology and its utility in the development of complex tests to betterdiagnose and treat patients. We are very excited about collaborating with Lillyon these important programs," McManus added.