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SAN DIEGO—Illumina Inc. has recently announced the launch of GRAIL, a new company formed to enable cancer screening from a simple blood test. Powered by Illumina sequencing technology, GRAIL will develop a pan-cancer screening test by directly measuring circulating nucleic acids in blood—also commonly known as circulating tumor DNA.
“We hope today is a turning point in the war on cancer,” said Jay Flatley, Illumina’s CEO and chairman of the board of GRAIL. “By enabling the early detection of cancer in asymptomatic individuals through a simple blood screen, we aim to massively decrease cancer mortality by detecting the disease at a curable stage.”
Detecting cancer at the earliest stages dramatically increases long-term survival. The successful development of a pan-cancer screening test for asymptomatic individuals would make the first major dent in global cancer mortality. GRAIL’s relationship with Illumina will provide the ability to economically sequence at the high depths necessary to create a screening test with the required sensitivity and a hoped-for level of specificity never before achievable for cancer screening.
“The Holy Grail in oncology has been the search for biomarkers that could reliably signal the presence of cancer at an early stage,” commented Dr. Richard Klausner, formerly chief medical officer at Illumina and National Cancer Institute director, and now a director of GRAIL. “Illumina’s sequencing technology now allows the detection of circulating nucleic acids originating in the cancer cells themselves, a superior approach that provides a direct rather than surrogate measurement.”
At the JP Morgan Healthcare Conference this January, Flatley said, “Only Illumina can sequence at the price points necessary to enable the large-scale trials required to demonstrate clinical utility and to ultimately market a test that is sensitive and economical across the global populations. In the earliest stages of disease, so few molecules from the cancer are present that targeting any small set of mutations for detection fails, simply due to statistical sampling. That challenge drives the need to look across a very broad set of potential mutations and to sequence at extraordinary depth to improve the signal-to-noise ratio. We expect the clinical trials could require sequencing between 100,000 and 300,000 genomes at about a 60X depth—the equivalent of two whole genomes per sample, implying a project that could be as large as six times the scale of what we are doing with genome mingling. And, of course, we have an imperative to do this quickly.”
“GRAIL’s rigorous, science-based approach with leading medical and policy advisors worldwide is unprecedented in the fight to defeat cancer,” Robert Nelsen, managing director and co-founder of ARCH Venture Partners and a director of GRAIL, said in a press release.
GRAIL has secured the counsel of a world-class set of industry and cancer experts for the company’s advisory board, including Dr. Richard Klausner; Dr. Jose Baselga, physician-in-chief at Memorial Sloan Kettering and president of the American Association of Cancer Research; Dr. Brian Druker, director of the OHSU Knight Cancer Institute; Mostafa Ronaghi, chief technology officer at Illumina; Don Berry, professor at MD Anderson Cancer Center; Timothy Church, professor at the University of Minnesota School of Public Health; and Charles Swanton, group leader at the Francis Crick Institute. The company will initially have a five-member board of directors, which will include Flatley, William Rastetter (chairman of Illumina), Klausner, Nelsen and the CEO, which GRAIL is actively recruiting.