By Bio-IT World Staff
March 10, 2015 | Illumina has brought another major pharmaceutical partner on board for its Universal Oncology Test program, an effort to build a next-generation sequencing-based gene panel covering all major cancer-related mutations that could be used to select personalized therapies. Illumina launched the program last August with partners Sanofi, AstraZeneca, and Janssen; today, Merck Serono became the fourth company pledging to use these tests in clinical trials of cancer drugs and, ultimately, as commercialized companion diagnostics.
The Universal Oncology Test System is part of Illumina's shift from being a platform provider to building its own portfolio of genetic tests, and is being developed for the FDA-cleared MiSeqDx sequencer. Its ambition is to gradually move the market toward a "companion therapeutics" model, where instead of running a series of tests to decide whether a patient's cancer could be targeted by specific drugs, labs could run a single test whose results might suggest any number of drugs.
Signing on to use the Universal Oncology Test could offer real advantages to drug developers, which usually partner with outside testing companies to pair new companion diagnostics with new therapies. Once the Illumina test is validated for use in one clinical trial, subsequent trials will have the advantage that the FDA will already be comfortable with the diagnostic. Adopting a "universal" test also acknowledges the reality that many leading academic medical centers have already moved toward a similar model, sequencing broadly across the genome to choose cancer therapies in difficult cases using their own in-house laboratory developed tests.
Merck Serono's R&D pipeline is dominated by oncology drugs, many of them targeted to specific cancer mutations.