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Company Bets on Catching Cancer With 'Liquid Biopsy'

Gene sequencing company Illumina is betting it can diagnose cancer in people long before they have symptoms.

Gene sequencing company Illumina is betting it can diagnose cancer in people long before they have any symptoms at all with a blood test called a liquid biopsy.

The San Diego-based firm launched a spinoff company Sunday named Grail, with obvious references to the "Holy Grail."

"The holy grail in oncology has been the search for biomarkers that could reliably signal the presence of cancer at an early stage," said Dr. Richard Klausner, a former director of the National Cancer Institute who's a member of the new company's board of directors.

The plan is to use Illumina's super-fast genetic sequencing technology to look for genetic material from tumor cells in peoples' blood long before they have any evidence of cancer. The test would check for genetic mutations known to be found in tumors.

Something similar is already done sometimes in people who already have cancer. The liquid biopsies are used to see how well cancer treatment is working.

Some big names in investing and cancer researcher are signing on for the enterprise.

They include Amazon founder Jeff Bezo's Bezos Expeditions, Microsoft co-founder Bill Gates and Sutter Hill Ventures. Klausner; Dr. Jose Baselga, physician in chief at Memorial Sloan Kettering Cancer Center and president of the American Association for Cancer Research; and Dr. Brian Druker, director of the Oregon Health & Science University, have signed on to the advisory board.

"We hope today is a turning point in the war on cancer," said Jay Flatley, Illumina's chief executive and chairman of Grail.

"By enabling the early detection of cancer in asymptomatic individuals through a simple blood screen, we aim to massively decrease cancer mortality by detecting the disease at a curable stage."

"We hope today is a turning point in the war on cancer."

It will be years before any such test could be designed, and it would have to be tested in thousands of people before regulators could consider approving it. Right now one of Illumina's whole-genome tests costs about $1,000, so it would be a pricey cancer screening test unless that cost can be brought down.

And while tumors are known to drop bits of genetic material into the blood, cancer experts caution that some early cancers may not secrete DNA fragments and require other types of detection.

Cancer is the No. 2 killer overall in the United States, but it's neck and neck with heart diseases.

Last week, the American Cancer Society projected that cancer would be diagnosed in close to 1.7 million Americans this year and that it would kill nearly 600,000. Most deaths are of people whose cancer had already spread before it was treated.

The U.S. Food and Drug Administration has been very skeptical of blood tests that claim to diagnose disease before people have symptoms.

In September, the FDA slapped Pathway Genomics over its "liquid biopsy" test that claims to do what Grail proposes.

The FDA said the company had not shown the $699 test worked, warned that it "may harm the public health" and said the company hadn't applied for proper regulatory approval.