GRAIL (company)

GRAIL is an American biotechnology and pharmaceutical company, which began in 2015 as a San Francisco start-up, with the purpose of developing an early cancer screening test for people who do not have symptoms. The parent company is Illumina of San Diego. Its headquarters is in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom.

GRAIL
TypeAmerican biotechnology and pharmaceutical company
Founded2015
Headquarters
Menlo Park, California
,
United States
ProductsGalleri test
ParentIllumina
WebsiteOfficial website

Their liquid biopsy, still undergoing research as of November 2020 and called the 'Galleri test', detects fragments of DNA in a blood sample via next-generation sequencing, which identifies DNA methylation, distinct patterns of which are associated with particular cancers, potentially allowing for the early detection of cancer and providing information of the origin of the cancer. It is one of three multicancer screening tests under investigation; the other two being the CancerSEEK assay and the PanSeer assay. On 27 November 2020 GRAIL announced a commercial partnership with the United Kingdom’s (UK) National Health Service (NHS), to trial the Galleri test, to which several scientists have responded.

Origin

GRAIL began as a San Francisco biotechnology and pharmaceutical startup company in 2015, the parent company being Illumina of San Diego, which produces most of the DNA sequencing machines that scientists use to study human biology and diagnose rare genetic diseases.[1][2][3][4] GRAILs headquarters is in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom, and its chairman is Jay Flatley.[1][5][6] According to Forbes in 2017, 20% of Grail's profits are kept by Illumina.[1]

Purpose

The company was set up with the purpose of developing an early cancer screening test for people who do not have symptoms.[7]

Activities

Illumina's own research showed that repeatedly sequencing DNA in the bloodstream made it possible to detect floating bits of DNA from cancer cells more accurately.[1] It initially aimed to recruit greater than 100,000 people into its clinical trials in order to accumulate the sizeable data required to detect and interpret cancer biomarkers.[8]

Galleri test

GRAIL calls its liquid biopsy for early cancer the 'Galleri test' or the 'Galleri multicancer early detection (MCED) test', one of three multicancer screening tests under investigation and being validated as of November 2020; the other two being the CancerSEEK assay and the PanSeer assay.[9][10] The Galleri test detects fragments of DNA in a blood sample via next-generation sequencing, which identifies DNA methylation, distinct patterns of which are associated with particular cancers, potentially allowing early detection of cancer and providing information of the origin of the cancer.[9]

GRAIL's first clinical trial for the Galleri test is the 'Circulating Cell-free Genome Atlas Study'.[8] The study looked at more than 50 distinctive cancer types in blood and tumour tissue samples from 15,254 people from 142 locations in North America, including people with new cancer and blood samples from people without a cancer diagnosis.[9] Subsequently the Galleri test entered into a further three trials; STRIVE, SUMMIT, and PATHFINDER studies.[9]

NHS

On 27 November 2020 GRAIL announced a commercial partnership with the United Kingdom’s (UK) National Health Service (NHS), to trial the 'Galleri test'.[6][11] The NHS England pilot will include two groups of participants; a group of 140,000 people identified through NHS records and aged 50 to 79 who have no symptoms, who will have a yearly blood test over three years, and a second group of 25,000 people with possible cancer symptoms.[6][11] The pilot is due to begin in mid-2021.[12]

Response to the news of the pilot has come from several scientists.[13][14]

Investors

Investors in the company have included:

References
  1. Herper, Matthew. "Company Will Raise $1 Billion To Create Blood Test To Detect Cancer". Forbes. Retrieved 27 November 2020.
  2. Rockoff, Jonathan D. (21 September 2020). "Sequencing Firm Illumina to Pay $7.1 Billion for Liquid-Biopsy Firm Grail". Wall Street Journal. ISSN 0099-9660. Retrieved 27 November 2020.
  3. Pedro Novo Melo; Carolina Machado (2018). Management and Technological Challenges in the Digital Age. CRC Press. p. 157. ISBN 978-0-429-81623-9.
  4. Kuchler, Hannah; Aliaj, Ortenca (21 September 2020). "Illumina agrees $8bn deal for cancer screening group Grail". www.ft.com. Financial Times. Retrieved 1 December 2020.
  5. "GRAIL Inc - Company Profile and News". Bloomberg.com. Retrieved 27 November 2020.
  6. "GRAIL And UK Government To Make Galleri Multi-Cancer Early Detection Blood Test Available To Patients". THE PHARMA DATA. Retrieved 27 November 2020.
  7. Francoise Simon; Glen Giovannetti (2017). "1. Digital evolution of biotechnology". Managing Biotechnology: From Science to Market in the Digital Age. John Wiley & Sons. p. 21. ISBN 978-1-119-21617-9.
  8. Harry Glorikian; Malorye Allison Branca (20 November 2017). MoneyBall Medicine: Thriving in the New Data-Driven Healthcare Market. Taylor & Francis. pp. 109–110. ISBN 978-1-351-98433-1.
  9. Beer, Tomasz M. (1 November 2020). "Novel blood-based early cancer detection: diagnostics in development". The American Journal of Managed Care. 26 (14): S292–S299. doi:10.37765/ajmc.2020.88533 – via Europe PMC.
  10. "Cancer detection: the quest for a single liquid biopsy for all". The Lancet Oncology. 21 (6): 733. 1 June 2020. doi:10.1016/S1470-2045(20)30033-4. ISSN 1470-2045. PMID 32502435.
  11. "NHS to trial 'game-changer' blood test for cancer in 2021". The Independent. 27 November 2020. Retrieved 27 November 2020.
  12. "NHS England » NHS to pilot potentially revolutionary blood test that detects more than 50 cancers". www.england.nhs.uk. Retrieved 30 November 2020.
  13. "Expert reaction to announcement of a new NHS pilot on a blood test for more than 50 cancers". Retrieved 28 November 2020.
  14. Campbell, Denis (27 November 2020). "NHS to trial blood test to detect more than 50 forms of cancer". the Guardian. Retrieved 28 November 2020.
  15. Garcia Rizo, Carolina (2018). "15. The Digital and In Silico Thearapeutics Revolution". In Rivas, Homero; Wac, Katarzyna (eds.). Digital Health: Scaling Healthcare to the World. Springer. p. 208. ISBN 978-3-319-61445-8.
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