Next-generation sequencing firm Illumina Inc. formed a new company seeking to enable comprehensive cancer-screening with just one blood test. The start-up, dubbed Grail, will focus on technologies to directly measuring circulating nucleic acids in blood.

To reach its goal, Illumina and ARCH Venture Partners are contributing $100 million in Series A financing, with additional investments coming from Bezos Expeditions, Bill Gates and Sutter Hill Ventures. Illumina will maintain majority control, the company said Jan. 10. [See Deal]

“The holy grail in oncology has been the search for biomarkers that could reliably signal the presence of cancer at an early stage,” said Richard Klausner, former Illumina Chief Medical Officer and National Cancer Institute 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,” he added.

Among Illumina’s existing DNA sequencing platforms are the company’s Illumina MiSeq and Illumina HiSeq products, cleared by FDA in November 2013. (See Also see "FDA Approves First Next-Generation DNA Sequencing Platforms" - Medtech Insight, 20 November, 2013..) The firm’s competitors include HTG Molecular Diagnostics Inc.’s EdgeSeq System (for research use only), and Pacific Biosciences of California Inc.’s PacBioRS II and Sequel System.(See [A#MT038339].)

Detecting cancer early in asymptomatic patients, and early treatment, is important to increasing long-term survival and cutting down on cancer rates overall, the company said.

A Political Moment?

Timing of the formation of the Grail company aligned with an enhanced political focus on cancer research. In his Jan. 12 State of the Union address, President Obama appointed Vice President Joe Biden to lead a “moonshot” effort by the federal government to partner with private companies to defeat cancer. The initiative could result in dedicated National Institutes of Health funding to bolster research into next-generation sequencing oncology screens, as well as federal government support for FDA regulatory efforts.

In fact, FDA recently announced plans to hold a Feb. 25 public workshop to obtain feedback on analytical and clinical validation approaches for next generation sequencing-based oncology panels. (See [A#01160118011].)

Illumina Aims For All-Inclusive Cancer Screen Via New Start-Up

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