By Bio-IT World Staff
August 21, 2014 | Illumina today announced a series of collaborations with large pharmaceutical companies, to participate in patient stratification for the development of new cancer drugs by offering a multi-gene panel that covers key cancer mutations. The panel will be built for the FDA-approved MiSeqDx sequencer, making it easier to incorporate into both clinical trials and, eventually, clinical practice. Illumina's press release notes that "125 known cancer driver genes have been discovered," though it stops short of stating that the company's new oncology panel will cover all of them.
Increasingly, cancer drugs are being tailored to narrow molecular subtypes of cancer, a trend that requires pharma companies to form diagnostic partnerships centered on "companion diagnostics," which the FDA can approve simultaneously with new drugs to both identify and treat appropriate patient populations. With its broad cancer assay, Illumina is seeking to turn that pattern on its head. A single diagnostic test, which can sort patients into many groups that may be susceptible to different drugs, could form the nucleus of several pharma partnerships to test targeted treatments. Illumina has adopted the term "companion therapeutics" to describe this model, as heard in an address to the Next Generation Dx Summit in Washington, DC, by Illumina's Vice President for Clinical Development and Medical Affairs, Daniel Grosu, earlier this week.
"The current paradigm I would call drug-centric precision oncology, because it starts with the drug," said Grosu in his presentation. "The emerging paradigm is one of patient-centered precision oncology," where molecular diagnostics come first and are followed by assignment to a matching therapy. "Curious minds wonder," Grosu continued, "are we witnessing the rise of the companion therapeutic? ...There is a widespread belief that the cancer diagnostics of the future are going to be very different from the cancer diagnostics of the past. They will have a lot more value, [and] be much closer to the front line of patient management."
Three pharma partners have already joined Illumina, to test drugs alongside the forthcoming oncology panel and work this test into their drugs' intended use statements. AstraZeneca, Sanofi, and Janssen Biotech, a subsidiary of Johnson & Johnson, will be the initial collaborators, who will also work with Illumina to advocate for a regulatory framework that supports sequencing assays as a component of clinical cancer care.