Illumina (NASDAQ: ILMN), the San Diego-based pioneer in gene-sequencing technology, says it has formed a new company called Grail to advance the sensitivity of technology already being used to detect infinitesimal pieces of DNA shed by cancerous tumors into the bloodstream.
In a conference call with analysts Sunday evening, Illumina CEO Jay Flatley laid out Illumina’s vision for Grail, with clinical trials beginning as early as 2017—with advanced sequencing technology that Illumina transferred to the startup.
If all goes according to plan, Grail would introduce a diagnostic test by 2019 to detect the most frequent types of cancer from a simple patient blood sample—long before patients show any symptoms, Flatley said.
“With Illumina sequencing technology, we believe we can create a ‘molecular stethoscope’ that will enable population-scale screening,” Flatley told analysts and investors.
Because the technology is used on a blood sample, such screening is sometimes referred to as a “liquid biopsy”—in contrast to a tissue biopsy. But the term “molecular stethoscope” has been used in recent years by Stanford’s Stephen Quake and Eric Topol of the Scripps Translational Science Institute to describe the same diagnostic technology, saying it enables scientists and doctors to “see inside the body at a molecular level.”
(Flatley’s reference also might have been a pointed jab at a new San Diego-based startup called Molecular Stethoscope, which was incorporated in October and is headed by Tina Nova, a successful San Diego life sciences entrepreneur who was previously a senior executive at Illumina.)
“Grail’s mission is to enable the detection of cancer in asymptomatic individuals through a simple blood screen, with the goal to massively decrease global cancer mortality,” Flatley said.
While the potential market opportunity for Grail is huge—Flatley estimated the global market at somewhere between $20 billion and $200 billion—he said a successful screening test would have to be priced below $1,000, and perhaps as low as $500. The Illumina CEO said there are now about 14 million new cases of cancer worldwide every year, with over 8 million cancer deaths annually.
Grail would operate as a separate company, majority owned by Illumina, with more than $100 million in initial funding from a Series A round led by Illumina and Arch Venture Partners. Bezos Expeditions, Bill Gates, and Sutter Hill Ventures also participated in the round, according to a statement from Illumina. The company will be based in San Francisco.
Illumina formed Grail as an independent startup, staffed by prominent scientific leaders with appropriate equity rewards, to create a more entrepreneurial environment “for quality science, breakthrough innovation, and ultimately success,” Flatley said.
In its statement, Illumina said Grail has “secured the counsel of a world-class set of industry and cancer experts for the company’s advisory board,” and is actively recruiting a CEO.
With existing technology, tumor DNA circulating in the blood of a cancer patient can be detected and sequenced to determine the specific mutations that are driving the particular type of cancer in each patient. Such mutations vary widely, even in the same type of cancer, and the information can help cancer doctors select an optimal course of treatment precisely matched to specific mutations.
But existing technology works best in more advance stages of cancer, when tumors are shedding substantial amounts of DNA into the bloodstream.
Grail intends to develop technology that can detect and characterize circulating tumor DNA at extremely low concentrations. “Detecting cancer at the earliest stages dramatically increases long-term survival,” Illumina says, “hence the successful development of a pan-cancer screening test for asymptomatic individuals would make the first major dent in global cancer mortality.”