GRAIL (company)

Grail (styled GRAIL) is an American biotechnology company, which began in 2015 as a start-up in San Francisco, California, seeking to develop an early cancer screening test for people who do not have symptoms.[1] Its headquarters is in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the UK. Its parent company is Illumina in San Diego, California.

GRAIL
TypeAmerican biotechnology company
Founded2015
Headquarters
Menlo Park, California
,
United States
ProductsGalleri test
ParentIllumina (pending US & EU legal review)
WebsiteOfficial website

Their liquid biopsy, which was launched in June 2021 and is 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 National Health Service (England) (NHS), to trial the Galleri test, reporting in 2026.

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.[2][3][4][5] Grail's chairman is Jay Flatley.[2][6][7] According to Forbes in 2017, 20% of Grail's profits are kept by Illumina.[2]

In September 2020, Illumina announced an agreement to purchase Grail outright for $7.1 billion.[8] In March 2021, the Federal Trade Commission sued to block the vertical merger.[9][10] In September 2022, an administrative judge ruled against the FTC's position on antitrust grounds.[11]

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.[2] 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.[12]

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.[13][14] 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.[13]

Grail's first clinical trial for the Galleri test is the 'Circulating Cell-free Genome Atlas Study'.[12] 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.[13] Subsequently the Galleri test entered into a further three trials; STRIVE, SUMMIT, and PATHFINDER studies.[13]

In November 2020 Grail announced a commercial partnership with the National Health Service (England) (NHS), to trial the 'Galleri test';[7][15][16] several scientists responded to the news.[17][18]

The NHS England interventional randomised controlled trial includes two groups of participants; a group of 140,000 people aged 50 to 79 identified through NHS records 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.[7][15] The trial started on 31 August 2021, with primary completion date estimated at 15 July 2024 and study completion on 28 February 2026.[19]

As of January 2023 at least seventeen clinical trials were in progress to investigate the performance and clinical utility of multicancer early detection tests, six of them involving Grail.[20]

Investors

Investors in the company have included:

References
  1. Simon, Francoise; 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.
  2. Herper, Matthew. "Company Will Raise $1 Billion To Create Blood Test To Detect Cancer". Forbes. Retrieved November 27, 2020.
  3. Rockoff, Jonathan D. (September 21, 2020). "Sequencing Firm Illumina to Pay $7.1 Billion for Liquid-Biopsy Firm Grail". Wall Street Journal. ISSN 0099-9660. Retrieved November 27, 2020.
  4. Novo Melo, Pedro; Machado, Carolina (2018). Management and Technological Challenges in the Digital Age. CRC Press. p. 157. ISBN 978-0-429-81623-9.
  5. Kuchler, Hannah; Aliaj, Ortenca (September 21, 2020). "Illumina agrees $8bn deal for cancer screening group Grail". ft.com. Financial Times. Retrieved December 1, 2020.
  6. "GRAIL Inc - Company Profile and News". Bloomberg.com. Retrieved November 27, 2020.
  7. "GRAIL And UK Government To Make Galleri Multi-Cancer Early Detection Blood Test Available To Patients". thepharmadata.com. Retrieved November 27, 2020.
  8. Rockoff, Jonathan D. (September 21, 2020). "Sequencing Firm Illumina to Pay $7.1 Billion for Liquid-Biopsy Firm Grail". Wall Street Journal. Retrieved March 31, 2021.
  9. Kendall, Brent; Rockoff, Jonathan D. (March 31, 2021). "FTC Seeks to Block Illumina's $7.1 Billion Acquisition of Life Sciences Firm Grail". Wall Street Journal. Retrieved March 31, 2021.
  10. "FTC Challenges Illumina's Proposed Acquisition of Cancer Detection Test Maker Grail". FTC.gov. Federal Trade Commission. March 30, 2021. Retrieved March 31, 2021.
  11. Loftus, Peter (September 1, 2022). "Illumina Wins Case Against FTC on Grail Acquisition". The Wall Street Journal.
  12. Harry Glorikian; Malorye Allison Branca (November 20, 2017). MoneyBall Medicine: Thriving in the New Data-Driven Healthcare Market. Taylor & Francis. pp. 109–110. ISBN 978-1-351-98433-1.
  13. Beer, Tomasz M. (November 1, 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. PMID 33200893.
  14. The Lancet Oncology (June 1, 2020). "Cancer detection: the quest for a single liquid biopsy for all". The Lancet Oncology. 21 (6): 733. doi:10.1016/S1470-2045(20)30033-4. ISSN 1470-2045. PMC 7266566. PMID 32502435.
  15. Gregory, Andy (November 27, 2020). "NHS to trial 'game-changer' blood test for cancer in 2021". The Independent.
  16. "NHS England » NHS to pilot potentially revolutionary blood test that detects more than 50 cancers". NHS England. Retrieved November 30, 2020.
  17. Several experts (November 27, 2020). "Expert reaction to announcement of a new NHS pilot on a blood test for more than 50 cancers".
  18. Campbell, Denis (November 27, 2020). "NHS to trial blood test to detect more than 50 forms of cancer". The Guardian. Retrieved November 28, 2020.
  19. "Does Screening With the Galleri Test in the NHS Reduce the Likelihood of a Late-stage Cancer Diagnosis in an Asymptomatic Population? A Randomised Clinical Trial". ClinicalTrials.gov. November 10, 2022. NCT05611632.
  20. Johnson, Kate (January 10, 2023). "Cancer Clinics See Patients Demanding New Cancer Detection Tests". Medscape.
  21. 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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