Illumina Raises $100 Million with Amazon’s Bezos, Bill Gates and Others to Launch Pan-Cancer Test Company Grail
January 11, 2016
By Mark Terry, BioSpace.com Breaking News Staff
San Diego-based Illumina , world leader in DNA sequencing technology, announced yesterday that it raised more than $100 million in Series A financing to start a new company, Grail, to develop a blood test to identify all types of cancers. Illumina was joined by ARCH Venture Partners, Sutter Hill Ventures, and Bezos Expeditions, run by Amazon founder and chief executive officer Jeff Bezos. Also joining was Microsoft co-founder Bill Gates.
Grail’s goal is ambitious, perhaps overly so. Illumina’s chief executive officer, Jay Flatley, told BloombergBusiness that Grail intends to create a “pan-cancer” screening test able to diagnose cancer at an early stage prior to symptoms. “This is a massive market,” Flatley said. “Depending on your assumptions, it’s somewhere between a $20 billion and $200 billion market opportunity.”
One simple reason for skepticism is that cancer is not a single disease, but numerous diseases that have a commonality of uncontrolled cell growth. Finding something in the blood that is common to all of them is unlikely, and developing a screening test to identify all possible cancerous mutations is ambitious, to say the least. On the other hand, if there’s any company in the world with the technology power to come up with a pan-screening test, it’s probably Illumina.
Other companies have developed “liquid biopsy” tests that use blood to detect cancers instead of, or as a supplement to, conventional biopsies. Guardant Health, for example, raised $100 million recently to fund its work, and Exosome Diagnostics recently raised $60 million.
Pathway Genomics in 2015 began offering a liquid biopsy test for early-stage cancer. The , however, dropped the hammer, questioning its reliability and indicating the test required regulatory approval. The FDA stated that there was not “any published evidence that this test or any similar test has been clinically validated as a screening tool for the early detection of cancer.”
Illumina’s Flatley argues that Grail plans to conduct DNA sequencing on 30,000 to 50,000 people over time as a way of building approval for its test. He also indicates that the test could possibly cost less than $1,000. That’s the current cost of being able to fully sequence the entire human genome using one of Illumina’s sequencers, although it is a complicated, expensive machine. However, prices are dropping dramatically.
Grail hopes to start a large-scale clinical trial in 2017. It also plans to have a single-cancer test available in 2017 as well. Optimistically, Flatley believes the pan-cancer test could be on the market in 2019.
To date, liquid biopsies are primarily used on patients who have already been diagnosed with cancer. They are generally used to narrow in on particular mutations in order to better select appropriate drugs, or to monitor treatment. Early-stage cancer detection has a number of complicating factors, including that all cells, not only cancer cells, shed DNA into the blood stream. Also, there are billions of possible mutations in each individual’s genome, not all of which are cancerous.
“As you age, you have mutations,” Luis Diaz, associate professor of oncology at Johns Hopkins, told The New York Times. Various structures in the body, including polyps, moles, and benign growths, also have similar mutations to tumors.
In order for Grail’s test to be really usable, it has to factor in the risks of false positives, which would cause patients significant stress with false cancer diagnoses, as well as the potential risk of unnecessary and potentially harmful biopsies, tests and treatments.
“Patients ought to be hesitant until there is really good data that this actually helps people,” Gilbert Welch, professor of medicine at Dartmouth and author of the book “Less Medicine, More Health” told The New York Times, “and they should remember that it could harm people.”
On the other hand, with the increasing power of gene sequencing technology and complex bioinformatics platforms, this could represent a paradigm shift in cancer diagnosis. “If this pans out,” Jose Baselga, physician in chief at Memorial Sloan Kettering Cancer Center, and head of Grail’s science advisory board, said to The New York Time, “this could be a real game changer.”