• Grail seeks to diagnose early-stage disease without symptoms
  • Startup aims for pan-cancer diagnostic on market by 2019

Genetic sequencing firm Illumina Inc. has formed a new company to develop a cancer-screening blood test, with investments from tech billionaires Bill Gates and Jeff Bezos.

The new company, to be called Grail, has more than $100 million in funding from Illumina, Arch Venture Partners, Sutter Hill Ventures, Bezos Expeditions and Gates, according to a statement on Sunday.

Grail’s goal is to create a “pan-cancer” screening test that can diagnose people at a very early stage even when they have no symptoms, said Jay Flatley, Illumina’s chief executive officer, in a telephone interview. “This is a massive market,” he said. “Depending on your assumptions, it’s somewhere between a $20 billion and $200 billion market opportunity.”

As the startup’s name implies, such a test is a much-sought and elusive goal for the industry. Using a blood sample to screen for cancer is an increasingly popular idea because blood draws are far cheaper and less invasive than traditional biopsies.

Proving Accuracy

The challenges to creating such a test are daunting because the technology is new and companies will have to prove that they can catch and track cancer cells as accurately as traditional methods if they hope to upend standard procedures. A false positive could cause undue patient anxiety, while a false negative could lead a patient’s cancer to go untreated.

But scientists have become more hopeful they can create a blood test because genetic sequencing has become more affordable and the technology has improved enough to detect just a few molecules of errant DNA in a vial of blood. Grail’s approach uses Illumina’s technology to detect bits of genetic material from cancers in the blood -- a bet that there’s enough detectable material to accurately find the presence of cancer.

Guardant Health Inc., a Silicon Valley firm that recently raised almost $100 million in financing, sells a test for advanced cancer patients to track how their cancer is mutating or responding to treatment. Other so-called “liquid biopsy” companies include Trovagene Inc. and Sequenom Inc.

Tech Billionaires

Illumina Chief Medical Officer Richard Klausner helped bring Microsoft Corp. co-founder Gates and Amazon.com Inc. CEO Bezos on board, according to the company. Flatley gave Bezos a presentation in October, and Bezos “was very excited about the idea,” he said. It’s not the first time that the tech billionaires have ventured into the world of health startups -- Bezos Expeditions was an investor in cancer drugmaker Juno Therapeutics Inc. and online appointment booking service ZocDoc Inc., while Gates hasbacked gene-editing company Editas Inc.

Grail differs from other tests on the marketplace because it seeks to catch cancer in healthy, undiagnosed individuals, Flatley said. Pathway Genomics Inc. was chided by the U.S. Food and Drug Administration in September for marketing a liquid biopsy test to healthy consumers and saying it could help them detect cancer early. The FDA said the test hadn’t been validated by science. Pathway said it has “performed appropriate validation of the test as a laboratory developed test” and is doing more studies.

Grail is aiming to start a large-scale clinical trial in 2017 and a test for a single cancer condition in the same year. The pan-cancer test will be on the market in 2019, according to Illumina. It should cost less than $1,000, Flatley said.

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