Illumina said today it launched a collaboration with Merck Serono—the biopharma unit of Merck KGaA—intended to develop a universal next-generation sequencing (NGS)-based oncology diagnostic. The value of the collaboration was not disclosed.

While saying it would continue pursuing separate collaborations announced in August 2014 with AstraZeneca, Johnson & Johnson’s Janssen Biotech, and Sanofi, Illumina said it will also work with Merck Serono to create a universal test system for clinical trials of targeted cancer therapies, with the goal of creating a more comprehensive tool for precision medicine.

Illumina said it is working with Merck Serono to develop assays that detect and measure multiple variants simultaneously to support clinical trials. The collaboration toward the universal cancer test will include test development, worldwide regulatory approvals, and global commercialization.

“This agreement is another step forward in realizing the promise of precision medicine,” Illumina CMO Richard Klausner, M.D., said in a statement. He cited President Obama’s proposed $270 million Personalized Medicine Initiative, which has called in part for expanding genetically-based clinical trials as a key approach for developing better treatments for cancer.

Added Susan Herbert, Head of Global Business Development at Merck Serono: “Our collaboration with Illumina around next-generation sequencing will enable us to perform genome studies at a pace unheard of a few years ago, and could lead to the development of several diagnostics.”

In detailing its efforts toward a Universal Oncology Test System last year, Illumina articulated four objectives:

  • Standardize: Enable standardization of a multiplexed platform for evaluating relevant genes.
  • Streamline: Optimize the introduction of new biomarkers by using a standardized system.
  • Decentralize: Deliver a universal platform for decentralized routine testing, enabling rapid commercial access.
  • Collaborate: Facilitate combination trials within and across pharmaceutical companies.

“The benefits of this NGS-based tumor assessment assay will be numerous. For pharmaceutical companies, it will streamline the validation of clinically relevant variants, the development of new cancer drugs, and the implementation of these new therapies into clinical treatment regimens,” Illumina said in a whitepaper published in November 2014 and available on its website.

Illumina added that it continues to collaborate with leaders of the Actionable Genome Consortium to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable widespread use of NGS.

Illumina co-formed the consortium in September 2014 with four cancer research institutes—Dana-Farber Cancer Institute, Fred Hutchinson Cancer Research Center, MD Anderson Cancer Center, and Memorial Sloan Kettering Cancer Center.

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