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Dx Focus: PrimeraDx, Lilly Ink CDx Deal; Response Genetics Offers New ALK Testing Program


PrimeraDx said this week that it has entered into a multi-year relationship with Eli Lilly to develop diagnostic products in support of multiple therapeutic development programs.

Under the agreement, the partners will develop multiplex assays using PrimeraDx's ICEPlex system, a benchtop system that runs assays based on PrimeraDx's scalable target amplification routine, or STAR, technology, which integrates standard endpoint PCR with capillary electrophoresis to simultaneously and quantitatively measure multiple target nucleic acids.

PrimeraDx and Lilly had worked together since at least 2011 to explore companion diagnostic development (PCR Insider, 7/14/2011); and last month PrimeraDx said that its relationship with the pharma company had matured to the point of looking into jointly building and registering an in vitro diagnostic for eventual approval by the US Food and Drug Administration (PCR Insider, 5/24/2012).

"We have great expectations of our collaboration with PrimeraDx," Andrew Schade, senior director of the Clinical Diagnostics Laboratory at Lilly, said in a statement. "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. Our early focus will be in oncology, but as with all of our early research, we will apply learnings across therapeutic areas."

Response Genetics this week announced the availability of a new anaplastic lymphoma kinase testing program aimed at providing a more complete picture of the ALK rearrangement status of non-small-cell lung cancer patients.

Specifically, Los Angeles-based Response will include its PCR-based EML4-ALK test results for patients testing negative for the ALK Break Apart fluorescence in situ hybridization test.

Approximately 3 percent to 5 percent of NSCLC tumors have a rearrangement of the ALK gene. In addition to providing the ALK Break Apart FISH assay, which has been clinically validated to predict response to the targeted therapy Xalkori (crizotinib), Response Genetics has a proprietary EML4-ALK RT-PCR-based assay that detects rearrangements of the ALK gene. The company's PCR test has identified ALK variants in a subpopulation of cases that are negative by FISH, and that may respond to Xalkori treatment. Samples that test negative for ALK FISH at Response Genetics will be further tested with the company's PCR test at "minimal cost," it said.