Illumina ILMN -0.45%, the leading maker of DNA sequencing equipment, is partnering with Sanofi , AstraZeneca , and Johnson & Johnson JNJ +0.95% to create a test for more mutations in dozens of genes that will be used first in clinical trials and, eventually, to help decide which patient should get which marketed drug.
The tool is necessary because new cancer drugs like Roche’s Zelboraf and Astra’s Iressa work only against cells that became cancerous because of particular genetic mutations. Detecting these mutations will allow doctors to pick drugs and cocktails of drugs aimed at the molecular machinery of a particular tumor. For instance, some research has shown that if a colorectal cancer tumor has a particular mutation, it might respond to the combination of a drug like Zelboraf and one like Iressa.
Earlier this year, I met with Richard Klausner, Illumina’s chief medical officer and the former director of the National Cancer Institute. He told me that he had been visiting large pharmaceutical companies with plans to develop a kind of master test. The idea is that companies would tell Illumina what cancer genes they are developing drugs targeted against. Then, using this information from all of these companies, it could create a genetic test that runs on its DNA sequencing machines that all companies could use in clinical trials, so that instead of developing tests one by one there would be a single test.
“The goal is that everyone will use a universal panel,” Klausner told me. This appears to be a step in that direction. Illumina says in its press release that the new test will look at at least 125 known cancer-causing genes. The test will run on MiSeqDx, the only next-generation DNA sequencing machine approved by the Food and Drug Administration. That could put Illumina in partial competition with some of its customers, like Foundation Medicine, which offers DNA sequencing tests for choosing cancer drugs, although Klausner told me he foresees technologies like Foundation’s being used for more complex analyses or more complicated cases. “I think there is plenty of room,” Klausner says.
“The transition to patient-centered companion therapeutics marks a new era for oncology, and we are pleased to see pharmaceutical companies working with Illumina on a universal platform to bring life- saving treatments through their development pipelines,” said Ellen V. Sigal, Ph.D., Chair and Founder of Friends of Cancer Research, in a prepared statement issued by Illumina. “This is the type of collaboration that will make real progress for patients.
Klausner told me in an interview last night that the partnerships with the drug giants will be three-pronged: a technical partnership for creating the tests; a regulatory partnership for dealing with the FDA and other regulators; and a commercial partnership, in which Illumina guarantees it will make the tests available where companies sell their drugs.
As a regulatory framework, this could be disruptive. The FDA currently talks about ‘companion diagnostics,’ that is, diagnostic tests that are paired with drugs. But Klausner says he is thinking in terms of ‘companion therapeutics’: in other words, all the drugs are paired with the same test. “It’s a big change,” he says. “The FDA is totally embracing it.”
For more on Illumina, its history, and the potential of DNA sequencing, read my profile of the company and its CEO, Jay Flatley, in the current issue of Forbes.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.