By Gail Kalinoski, Contributing Reporter

Touting it as a “significant development in the war on cancer,” Illumina, Inc., formed a new company – GRAIL – to develop a blood-based screening test that could detect early-stage cancers in asymptomatic individuals.

Illumina, based in San Diego and the world’s largest DNA sequencing company, will be the majority owner of GRAIL. Other investors in the company, which has initial funding of more than $100 million, include venture capital firms Arch Venture Partners and Sutter Hill Ventures, Microsoft co-founder Bill Gates and Bezos Expeditions. The company is searching for a CEO, but already has an advisory board of world-class cancer specialists and board of directors.



“We hope today is a turning point in the war on cancer,” Jay Flatley, Illumina CEO and chairman of the board of GRAIL, said in a company statement. “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.”

Powered by Illumina’s sequencing technology, GRAIL will develop a pan-cancer screening test by measuring circulating nucleic acids in the blood. The plan is to get the cost per test to $1,000 or less and make it available through visits to a doctor or testing center, according to MIT Technology Review.

“The holy grail in oncology has been the search for biomarkers that could reliably signal the presence of cancer at an early stage. 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,” said Dr. Richard Klausner, formerly Illumina CMO and NCI director, and a director at GRAIL.

Genetic Engineering & Biotechnology News reported that GRAIL plans to spend the first year in research and development and launch large-scale clinical tests in 2017, with the goal of delivering a pan-cancer test by 2019 and possibly tests for more targeted cancers like breast and lung cancer even earlier.

“It may be the case that the test is exactly the same,” Flatley said during a conference call with reporters, according to Genetic Engineering & Biotechnology News. “It’s just that we would be applying it in a much more limited way, early on, to specific cancers, whereas in the long run it would be intended to be pan-cancer, and cover as many cancers as the clinical trial demonstrates are effective in diagnosing these early cases.”

“If this pans out, this could be a real game changer,” Dr. Jose Baselga, physician in chief at Memorial Sloan Kettering and a member of GRAIL’s advisory board, said during the conference call, according to The New York Times.

Some experts cautioned that obstacles remain even if the presymptomatic cancer screening test is developed. Will the test find all cancers or potentially give wrong results? Some early-stage cancers may never cause harm but patients may nonetheless be exposed to expensive and aggressive treatments. Other companies are also pursuing similar tests known as liquid biopsies to be part of a market that may grow from $20 billion to as much as $200 billion if blood screening can eventually detect stage 1 cancers.

But MIT Technology Review notes that Flatley believes GRAIL’s advantage will be the sequencing technology provided by Illumina that will help it keep its costs lower than competitors.

“In this case, we didn’t think the market could do it fast enough, unless we destroyed our (business) by giving away sequencing,” Flatley said. “We don’t think anyone else can do it at scale.”