CHICAGO Jan 10 Gene sequencing company Illumina
Inc is going after the next big advance in cancer
detection, working to develop a universal blood test to identify
early-stage cancers in people with no symptoms of the disease.
On Sunday, San Diego-based Illumina said it would form a new
company, called Grail, with more than $100 million in Series A
financing. Illumina will be the majority owner. Key investors
include ARCH Venture Partners, Sutter Hill Ventures and Bezos
Expeditions, the venture investment fund of Amazon
founder Jeff Bezos.
Grail's test will use Illumina's DNA sequencing technology
to scan for bits of cancer genes originating in tumors and
circulating in the bloodstream. The hope is to detect many types
of newly forming cancers, which could be treated at an earlier
stage to increase the chances of survival.
Cowen & Co estimates that use of DNA blood tests for cancer
screening will exceed $10 billion a year by the end of the
decade. Several companies are developing liquid biopsies, mostly
for use with patients already diagnosed with cancer.
Experts say it will take huge clinical trials to provide the
kind of evidence necessary to make DNA blood tests part of
routine cancer screening. Direct-to-consumer testing company
Pathway Genomics last year launched a DNA blood test for healthy
people without having conducted such trials. Illumina, a much
bigger player, intends to provide that evidence.
Illumina Chief Executive Jay Flatley, who will serve as
chairman of Grail, said work on the new test began some 18
"We've made tremendous progress, which gives us the
confidence that we can get to the endpoint that we expect,"
Flatley said in an interview.
He believes it will take at least an additional year of
research and development to refine the test. Grail will then
conduct clinical trials of the test on as many as 300,000 human
genomes, which could take another two years.
Illumina aims to have its test on the market by 2019 and
hopes the cost of DNA sequencing will have dropped enough to
price the cancer screening test around $500 each, low enough to
make it widely accessible, Flatley said.
PiperJaffray analysts estimated that as many as 38 companies
are developing cancer blood tests using DNA sequencing, but most
of these so-called "liquid biopsies" use the tests in patients
already diagnosed with cancer to see how they are responding to
treatment or to check for mutations or drug resistance.
Critics said there is not enough evidence yet that a blood
test can screen for cancer in healthy people.
Pathway Genomics' screening test
claiming to detect 10 cancers in healthy people drew the ire of
the U.S. Food and Drug Administration last year, which sent the
company a letter saying the test "had not received adequate
clinical validation and may harm the public health."
Flatley said Grail will consult early on with the FDA to see
what evidence the agency needs for the test and will likely seek
its approval. He said the company has not yet decided whether
the test will be offered directly to consumers, but it is
Illumina's investment will result in a hit to earnings, but
Flatley would not say how much at this point. "The actual
economics of Grail will be fully disclosed in our financials,"
(Reporting by Julie Steenhuysen; Editing by Michele Gershberg,