Pairing up for precision medicine
by Kelsey Kaustinen	| Email the author
Illumina Inc.
Merck Serono
Merck KGaA
Janssen Biotech Inc.
SAN DIEGO—Illumina Inc. and Merck Serono, the biopharmaceuticals business of Merck KGaA, have announced a collaboration with an eye toward developing a universal next- generation sequencing (NGS)-based oncology diagnostic. The two companies will work together to create a universal test system for clinical trials of targeted cancer therapies in hopes of creating a more comprehensive option.
"This agreement is another step forward in realizing the promise of precision medicine," Dr. Richard Klausner, chief medical officer for Illumina, noted in a statement. "The U.S. government's Precision Medicine Initiative, recently announced by President Obama, specifically outlines the need to expand genetically based clinical trials as a key approach for developing better treatments for cancer. We are very excited to work with Merck Serono on this endeavor."
Per a Merck Serono spokesperson, the partners will collaborate on the development of assays that can simultaneously detect and measure multiple genetic variants in a single tumor sample in a clinical trial setting. Merck Serono and Illumina will work together on regulatory submission, and Illumina will be responsible for global commercialization. The spokesperson adds that "Illumina's successful regulatory track record was an important consideration in the collaboration, as next-generation sequencing platforms cleared by a regulatory agency could accelerate the development of an assay and facilitate the registration of a companion diagnostic. Furthermore, Illumina is providing the investigational-use only version of the onco gene panel to Merck Serono early in drug development, and the panel contains all genetic alterations of interest to Merck Serono."
"Diagnostics have the potential to offer meaningful and differentiated value to patients, and possibly improved clinical outcomes, by delivering therapies that are tailored to biology behind the disease," says Merck Serono's spokesperson. "So far, the paradigm has been to develop one diagnostic for one drug, which means that selection of a given drug for treating patients is dependent on the physician ordering the corresponding test. As many new targeted therapies come to the market, it is increasingly difficult to perform all tests with very limited patient samples. The NGS oncology panel will provide a more open approach, through which firstly a patient's tumor drivers are identified through the testing, and the various genetic alterations will be predictive for different approved targeted drugs, which the physician can then prescribe with greater confidence."
This is the latest of Illumina's efforts to advance an NGS-based oncology test system. In August 2014, Illumina announced similar collaborative partnerships with AstraZeneca, Janssen Biotech Inc. and Sanofi for the development of assays for such a multigene panel. Illumina is also engaged with key thought leaders to establish standards for NGS-based assays in routine clinical oncology practice and regulatory frameworks to allow for this new testing paradigm. Those thought leaders include figures from the Actionable Genome Consortium, which was established in September 2014 to recommend openly published standards for the widespread use of NGS in clinical oncology. The primary purpose is to define the principles and content of the "cancer actionable genome," or a comprehensive description of genomic alterations that define patient tumors. Founding members include Illumina, the Dana-Farber Cancer Institute, Fred Hutchinson Cancer Research Center, MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center.
Citing a 2013 Science paper titled "Cancer genome landscapes," Illumina noted in a press release that "To date, 125 known cancer driver genes have been discovered—71 tumor suppressors and 54 oncogenes—that drive tumor growth through 12 cellular signaling pathways." Considering that and the fact that "an estimated 800 oncology drugs are in development, many of which are designed to target specific mutations … there is growing need for new companion diagnostic tests."
"The emergence of targeted therapies in oncology brings an increased need for companion diagnostic tests. Next-generation sequencing is an ideal solution to transform the tumor profiling paradigm from a series of single gene tests to a multi-analyte approach to delivering precision oncology," Illumina explains on its website, adding that this universal oncology test system "will deliver a comprehensive set of the currently actionable and emerging biomarkers relevant to cancer drug development."