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PrimeraDx Bolsters CDx Development Efforts with Quest Diagnostics Agreement

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This article has been updated from a previous version to include comments from PrimeraDx.

PrimeraDx and Quest Diagnostics will co-develop and commercialize molecular diagnostic products and services with a focus on supporting clinical development of targeted therapeutics for drug developers, the companies said this week.

Under the non-exclusive agreement, Quest Diagnostics' Clinical Trials business has the right to use PrimeraDx's ICEPlex system to independently develop and use laboratory tests in early-phase biomarker and drug-development studies and clinical trials with its pharmaceutical and medical device clients.

This is PrimeraDx's second partnership focused on using ICEPlex, its multiplex and multimodal PCR and capillary electrophoresis system, as a tool for companion diagnostic development. The company also has such an agreement in place with Eli Lilly.

For Quest, the alliance provides it with a multimodal platform that can detect a variety of genetic alterations, which may be more attractive than using multiple platforms for such analyses, company officials said.

ICEPlex is a benchtop system that runs assays based on PrimeraDx's scalable target amplification routine, or STAR, technology, which integrates standard endpoint PCR and CE to simultaneously and quantitatively measure multiple target nucleic acids from one well.

More specifically, ICEPlex continuously samples PCR reactions containing fluorescently labeled primers during sequential cycles of amplification. The amplified products can then be detected and sized using CE, and the amplification kinetics can be reconstructed using real-time PCR algorithms to quantify the amount of material in the initial sample.

The company maintains that the technology enables a much higher level of multiplexing than is possible with real-time PCR techniques that use fluorescent probes, such as TaqMan-based methods; and can simultaneous quantify multiple gene targets — a few dozen for practical purposes but a few hundred, theoretically — from a single reaction.

The system can also detect and quantify disparate target types — including mRNA, miRNA, SNPs, DNA mutations, fusions, and DNA methylation — making it well-suited to conduct research and development for diseases, such as cancer, that involve systemic or multiple molecular changes, the company said.

Mansfield, Mass.-based PrimeraDx launched ICEPlex in August 2011, with an initial focus on infectious disease assay development. However, by mid-2012 the company had also begun investigating ways and exploring partnerships to better position ICEPlex for oncology studies, and specifically CDx development.

PrimeraDx had been exploring this possibility with Lilly since 2011, and in June 2012 the companies made it official by entering into a multi-year partnership to develop diagnostic products in support of multiple therapeutic development programs at Lilly (PCR Insider, 6/28/2012).

Now PrimeraDx has struck its second CDx agreement, this time with Quest. Under the partnership, PrimeraDx will maintain rights to develop and market in vitro diagnostic products, assuming the targeted therapies they accompany receive US Food and Drug Administration approval.

In addition, Quest has rights to validate and offer clinical diagnostic information services, based in part on the assays created during drug development, to aid in making treatment decisions for those drugs that are successfully commercialized and FDA-approved for clinical use.

The companies said in a statement that they expect to focus their initial collaborations on cancer, although they may also explore opportunities in infectious diseases, genetics, and other conditions.

"We expect the kinds of cancer opportunities will vary, based on the drug sponsor's specific needs," Terry Robins, global director of scientific affairs and biomarker research and development for Quest, said in an email this week.

Robins added that among the reasons Quest chose the ICEPlex platform is that "if a molecular diagnostic is appropriate in the treatment paradigm, even for disparate therapies, [ICEPlex's] multi-modal and multiplexing capabilities make it attractive."

Further elaborating on this point, Rich Heichemer, director of companion diagnostics at Quest, said in an email that "various sponsors have expressed concerns about maximizing patient treatment alternatives when tissue sample is very limited."

In those cases, he added, "a multimodal platform that allows for different kinds of genetic alterations to be detected in a single analysis may be a better option to splitting the sample over multiple platforms. In other instances, sponsors may find that a treatment population is best targeted by a combination of genetic alterations. Again, that's a good fit for a multimodal platform that can provide an interpretation based on the combination of those markers."

Parallel to its oncology and CDx work, PrimeraDx is still developing infectious disease assays on ICEplex. In September, the platform and accompanying Clostridium difficile assays received CE marking (PCR Insider, 9/13/2012).

PrimeraDx had originally planned to submit the ICEPlex C. difficile test to the FDA last year. However, in June the company said it was delaying that FDA submission in order to rework it and better reflect the quantitative nature of its test, as well as put more resources into CDx development.

This week, a company representative told PCR Insider in an email that it is currently wrapping up a multi-site clinical trial for the C. difficile assay, and that early data is positive. The representative added that PrimeraDx hopes to submit the assay and ICEPlex platform for FDA clearance by the end of the second quarter of this year.

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