Based: Menlo Park, CA
San Diego-based Illumina, a leading maker of gene-sequencing technology, shook up the liquid-biopsy world in January 2016 with the announcement that it was spinning off its work in the field and forming a new company called Grail. But unlike other liquid biopsy developers, which focus on tracking tumor DNA in patients who have already been diagnosed with the disease, Grail’s ambition is to use genomic sequencing to develop a blood test that can be performed, say, during an annual physical to detect cancer—any cancer—when it’s in its earliest stages and therefore potentially curable.
The company attracted an impressive list of early backers, raising $100 million in a Series A financing from the likes of ARCH Venture Partners, Bill Gates and Bezos Expeditions. Then, a year after it launched, Grail made headlines by revealing plans to raise a remarkable $1 billion in a Series B—an unheard-of sum in the world of biotech and medical devices. Grail's CEO is Jeff Huber, a Google veteran whose resume includes helping to develop that company’s ultrapopular Maps and Earth apps.
What makes Grail fierce
The technology at the heart of Grail is what’s known as “ultradeep sequencing,” which will allow the company to look broadly across the cancer genome and then develop a test that designed to spot tiny bits of tumor DNA that’s cast into the bloodstream. That’s a far more complicated task than developing liquid biopsy tests, Huber says. “Liquid biopsy is a relatively limited [gene] panel that’s used to guide treatment options, by mapping a gene target to a specific therapy that can be prescribed,” Huber says. “Screening is a much bigger technical challenge. Cancer is incredibly diverse. We have to look very broadly across the genome, and at a much earlier stage, when the concentrations of fragmentary DNA are very low. The approach we’re taking is 10 times more than anyone else in terms of breadth.”
Huber is driven not just by his love of technologies that can change the lives of millions of people, but also by a personal tragedy that drove home the importance of early detection. Huber’s wife, Laura, was diagnosed with late-stage colon cancer at age 46 after showing virtually no symptoms. Her treatment was “an 18-month fight that she lost, and the reason was that it was an uphill battle from the beginning,” he says. “Most cancers are diagnosed at stage 3 or 4. If we can detect cancer at stage 1 or stage 2 the outcomes are generally very good—80% to 90% of people can be cured.”
What to look for
Grail has been building its clinical and technology ranks, hiring 100 people since it was founded, Huber says. The company is now recruiting 10,000 volunteers for its Circulating Cell-free Genome Atlas Study (CCGA), a massive effort to characterize the genetic makeup of several cancer types at every stage of the disease. The study will involve collecting blood and clinical data from 7,000 cancer patients and 3,000 healthy people. Illumina CEO Jay Flatley has said that if all goes well, Grail could be ready to roll out a test by 2019.
The data in the atlas will be used to perfect Grail’s technology, so its tests will ultimately be able to do much more than just detect cancer at its earliest stages, Huber says. “With a blood test, we want to be able to tell you where the cancer is, how aggressive it is and what its trajectory is likely to be,” Huber says. “We hope to be able to provide feedback that can guide your doctor to the therapeutic path that’s best for you.” — Arlene Weintraub, @FierceBiotech