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  • Writer's pictureKirk Hartley

Grail: A Bold Goal of Having on the Market by 2019 A Cheap, Globally Available Blood Based Screenin

Image from Illumina's press conference announcing its bold new plan to change how the world of cancer.

Image from Illumina’s press conference announcing a bold new plan to change how the world deals with cancer.

Did you feel the earth move Sunday evening? It did. That’s when a group of visionary leaders announced Grail, a brilliant attempt to rewrite how the world deals with cancer.

The team to get it done is impressive, to say the least. The plan was announced Sunday evening by Illumina’s CEO, Jay Flatley. Illumina is by far the world’s leader in gene sequencing. Other backers are Bill Gates and Jeff Bezos, and some stalwarts of biotech private equity investing.

An MIT story on Grail is here. The gist is the goal is to have on the market by 2019 a blood based test to screen for every form of cancer long before it would be found by conventional means.  It’s a door to medical monitoring, writ very large. Clinical trials are expected to start in 2017, and to include around 30,000 people.

The intent is to create a screening test that would find all cancers by stage II or earlier (they hope for stage 1). They are planning to do at least 60x level genomic analysis.

Distribution will be global. They hope for a price per test of between $500 and $1,000. A Forbes story is here.

A hope, they said, is for Grail to end up with a direct to consumer test. The company will be based in the San Francisco area. But you can almost certainly bet it will overseas operations that arguably can and should sell tests directly to consumers, regardless of the thinking of the FDA.

The press release is pasted below; note the rock stars of cancer involved, including Richard Klausner, the former director of the National Cancer Institute, and leaders from major cancer centers.

Title: Illumina Forms New Company to Enable Early Cancer Detection via Blood-Based Screening

Date(s): 10-Jan-2016 5:29 PM

For a complete listing of our news releases, please click here

Significant Development in the War on Cancer

SAN DIEGO–(BUSINESS WIRE)–Jan. 10, 2016– Illumina, Inc. (NASDAQ:ILMN) today announced GRAIL, a new company formed to enable cancer screening from a simple blood test. Powered by Illumina sequencing technology, GRAIL will develop a pan-cancer screening test by directly measuring circulating nucleic acids in blood.

Detecting cancer at the earliest stages dramatically increases long-term survival, hence the successful development of a pan-cancer screening test for asymptomatic individuals would make the first major dent in global cancer mortality.

GRAIL’s unique structure enables it to take on this grand challenge. GRAIL has been formed as a separate company, majority owned by Illumina. GRAIL is initially funded by over $100 million in Series A financing from Illumina and ARCH Venture Partners, with participating investments from Bezos Expeditions, Bill Gates and Sutter Hill Ventures. GRAIL’s unique relationship with Illumina provides the ability to economically sequence at the high depths necessary to create a screening test with the required sensitivity and a hoped for level of specificity never before achievable for cancer screening.

“We hope today is a turning point in the war on cancer,” said Jay Flatley, Illumina Chief Executive Officer and Chairman of the Board 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.”

“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, formerly Illumina Chief Medical Officer and NCI Director, and a Director of GRAIL. “Illumina’s sequencing technology now allows the detection of circulating nucleic acids originating in the cancer cells themselves, a superior approach that provides a direct rather than surrogate measurement.”

“GRAIL’s rigorous, science-based approach with leading medical and policy advisors worldwide is unprecedented in the fight to defeat cancer,” said Robert Nelsen, Managing Director and Co-Founder of ARCH Venture Partners and a Director of GRAIL.

GRAIL has secured the counsel of a world-class set of industry and cancer experts for the company’s advisory board, including Dr. Richard Klausner; Dr. Jose Baselga, Physician In Chief at Memorial Sloan Kettering and President of the American Association of Cancer Research; Dr. Brian Druker, Director, OHSU Knight Cancer Institute; Mostafa Ronaghi, Chief Technology Officer at Illumina; Don Berry, Professor at MD Anderson Cancer Center; Timothy Church, Professor at the University of Minnesota School of Public Health and Charles Swanton, Group Leader at the Francis Crick Institute. The company will initially have a five-member Board of Directors, including Jay Flatley, William Rastetter (Chairman of Illumina), Dr. Richard Klausner, Robert Nelsen, and the CEO. The company is actively recruiting a CEO.”

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