top genetic sequencing company and a bevy of big-name investors are launching a new company that aims to detect cancer through a blood test.
The startup, called Grail, aims to fish little bits of genetic material out of the blood, sequence them, and use them to identify extremely early cancers. It’s being spun out of Illumina, Inc., a global giant in gene sequencing and backed by $100 million, including investments from Microsoft co-founder Bill Gates, Amazon founder Jeff Bezos, and Silicon Valley private equity firm Sutter Hill Ventures.
Grail intends to “revolutionize cancer screening” in people with no symptoms of the disease, said Illumina CEO Jay Flatley, identifying the disease “at the earliest stages when it can be cured.”
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The blood analysis, known as “liquid biopsy,” has become one of the hottest areas in biotechnology, though most companies want to use it to monitor existing cancer patients for signs that their disease has returned after treatment. Just last week, startup Guardant Health raised $100 million to continue its work on a liquid biopsy for patients with advanced cancer. Also last week, Exosome Diagnostics, which is also working on liquid biopsy, closed a $60 million funding round.
But it’s as yet unclear whether detecting cancer cells in the blood before any symptoms emerge will improve outcomes for patients.
A San Diego firm, Pathways Genomics, began marketing an early detection liquid biopsy test last year, selling it direct to consumers for $299. It claimed its CancerIntercept Detect tests could spot early signs of 10 cancers. The Food and Drug Administration responded with a letter demanding further information. “We believe you are offering a high risk test that has not received adequate clinical validation and may harm the public health,” regulators wrote.
But Dr. Richard Klausner, senior vice president of Illumina, said there is solid science behind the liquid biopsy concept.
The vast majority of cancers shed DNA or a related molecule, RNA, into the blood, Klausner said. Called circulating tumor nucleic acids (ctNAs), they “leave a molecular trail that can be followed,” he said.
“This is the long-sought holy grail of oncology,” said Klausner, a former director of the National Cancer Institute. It will be like having “a molecular stethoscope,” he said.
Flatley estimated the market for this sort of blood-based early-cancer detection at up to $100 million. Grail hopes to have one on the market by 2019.
Grail will take over research that Illumina had embarked on last year with Memorial Sloan Kettering Cancer Center to understand the biology of circulating tumor DNA. The cancer center collects samples, and Illumina uses its sequencing technology to detect ctDNA in those samples, said Dr. Jose Baselga, physician-in-chief and chief medical officer at Sloan Kettering.
The two will soon launch what Klausner called “the most extensive clinical studies ever” of whether ctDNAs can be identified specifically and selectively enough to be used clinically. Among the key questions: Are the rates of false positives (“detecting” a cancer that doesn’t exist) and false negatives (missing a true cancer) low enough to be used in patients?
To answer that, Grail and Sloan Kettering will launch a large study with as many as hundreds of thousands of healthy people to see whether ctNA detection makes a difference in their health outcomes. They are starting with breast and lung cancer, and plan to expand to ovarian, kidney, and other solid cancers.