GRAIL
TypeSubsidiary
IndustryBiotechnology
Founded2015 (2015)
Headquarters
Menlo Park, California
,
United States
ProductsGalleri test
ParentIllumina, Inc.
Websitegrail.com

Grail (styled GRAIL) is an American biotechnology company in Menlo Park, California. It is a subsidiary of Illumina started as a startup seeking to develop an early cancer screening test for people who do not have symptoms.[1]

Their liquid biopsy (also called multi-cancer early detection test[2]) 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 multi-cancer screening tests under investigation; the other two being the CancerSEEK assay and the PanSeer assay.

History

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.[3][4][5][6] Richard Klausner, then chief medical officer at Illumina and former director of the National Cancer Institute, advocated for the new business. According to the San Francisco Business Times, he correctly predicted how DNA sequencing technology would make it possible to detect evidence of a tumor from a blood sample.[7] He also joined Grail's board of directors.[8] According to Forbes in 2017, 20% of Grail's profits are kept by Illumina.[3]

In September 2020, Illumina announced an agreement to purchase Grail outright for $7.1 billion.[9]

On November 27, 2020, Grail announced a commercial partnership with the National Health Service (England) (NHS), to trial the Galleri test, reporting in 2026.

In March 2021, the Federal Trade Commission (FTC) sued to block the vertical merger.[10][11] In September 2022, an administrative judge ruled against the FTC's position on antitrust grounds.[12]

In October 2023, the European Commission ordered Grail to be divested from Illumina within the next twelve months.[13]

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.[3] 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.[14]

Galleri test

Grail calls its liquid biopsy for early cancer the Galleri test or the Galleri multi-cancer early detection (MCED) test, one of three multi-cancer screening tests under investigation and being validated as of November 2020; the other two being the CancerSEEK assay and the PanSeer assay.[15][16] 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.[15]

Grail's first clinical trial for the Galleri test is the 'Circulating Cell-free Genome Atlas Study'.[14] 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.[15] Subsequently the Galleri test entered into a further three trials; STRIVE, SUMMIT, and PATHFINDER studies.[15] Results from PATHFINDER presented in September 2022 showed a 43.1% positive predictive value for the detection of early-stage cancer, with the test predicting the cancer signal origin with 97% accuracy in less than three months' time.[17]

Galleri received breakthrough device designation from the U.S. Food and Drug Administration in May 2019.[18] The test does not diagnose cancer;[19] rather, it detects possible signs of cancer in order to help direct follow-up diagnostic testing.[20] Galleri is not yet approved by the FDA, but it is available by prescription under the agency's provision for laboratory developed tests.[21] The test does not diagnose cancer;[19] rather, it detects possible signs of cancer in order to help direct follow-up diagnostic testing.[22]

In November 2020 Grail announced a commercial partnership with the National Health Service (England) (NHS), to trial the Galleri test;[23][24] several scientists responded to the news.[25][26]

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.[23] The trial started on August 31, 2021, with primary completion date estimated at July 15, 2024, and study completion on February 28, 2026.[27] In June 2021, the company began selling Galleri tests in the U.S.[28]

As of January 2023 at least seventeen clinical trials were in progress to investigate the performance and clinical utility of multi-cancer early detection tests, six of them involving Grail.[29]

In June 2023, Grail disclosed that its telemedicine vendor PWNHealth mistakenly informed 408 of its patients that they may have cancer. The company asserted that the incident was due to a software configuration issue at PWNHealth, not due to incorrect Galleri test results.[30][31]

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. ↑ Pyzocha, Natasha J. (October 2022). "Galleri Test for the Detection of Cancer". American Family Physician. 106 (4): 459–460. ISSN 1532-0650. PMID 36260909.
  3. 1 2 3 Herper, Matthew. "Company Will Raise $1 Billion To Create Blood Test To Detect Cancer". Forbes. Retrieved November 27, 2020.
  4. ↑ 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.
  5. ↑ Novo Melo, Pedro; Machado, Carolina (2018). Management and Technological Challenges in the Digital Age. CRC Press. p. 157. ISBN 978-0-429-81623-9.
  6. ↑ Kuchler, Hannah; Aliaj, Ortenca (September 21, 2020). "Illumina agrees $8bn deal for cancer screening group Grail". ft.com. Financial Times. Retrieved December 1, 2020.
  7. ↑ Leuty, Ron (May 27, 2021). "Biotech's elder statesman is still going strong". San Francisco Business Times. Retrieved June 25, 2023.
  8. ↑ "Illumina Launches GRAIL, Focused on Blood-Based Cancer Screening". GEN - Genetic Engineering and Biotechnology News. January 11, 2016. Retrieved June 25, 2023.
  9. ↑ 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.
  10. ↑ 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.
  11. ↑ "FTC Challenges Illumina's Proposed Acquisition of Cancer Detection Test Maker Grail". FTC.gov. Federal Trade Commission. March 30, 2021. Retrieved March 31, 2021.
  12. ↑ Loftus, Peter (September 1, 2022). "Illumina Wins Case Against FTC on Grail Acquisition". The Wall Street Journal.
  13. ↑ Chee, Foo Yun (October 12, 2023). "Illumina ordered by EU antitrust regulators to sell Grail". Reuters.
  14. 1 2 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.
  15. 1 2 3 4 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.
  16. ↑ 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.
  17. ↑ "903O - A prospective study of a multi-cancer early detection blood test". ESMO Congress – OncologyPRO. September 11, 2022. Retrieved July 26, 2023.
  18. ↑ Tirumalaraju, Divya (May 14, 2019). "Grail gets FDA breakthrough designation for multi-cancer test". Medical Device Network. Retrieved June 26, 2023.
  19. 1 2 "The Galleri Blood Test: What To Know". Health. December 21, 2022. Retrieved July 26, 2023.
  20. ↑ Sample, Ian (September 11, 2022). "Blood test spots multiple cancers without clear symptoms, study finds". The Guardian. Retrieved July 26, 2023.
  21. ↑ Kolata, Gina (June 10, 2022). "Blood Tests That Detect Cancers Create Risks for Those Who Use Them". The New York Times. Retrieved June 25, 2023.
  22. ↑ Sample, Ian (September 11, 2022). "Blood test spots multiple cancers without clear symptoms, study finds". The Guardian. Retrieved July 26, 2023.
  23. 1 2 Gregory, Andy (November 27, 2020). "NHS to trial 'game-changer' blood test for cancer in 2021". The Independent.
  24. ↑ "NHS England » NHS to pilot potentially revolutionary blood test that detects more than 50 cancers". NHS England. Retrieved November 30, 2020.
  25. ↑ Several experts (November 27, 2020). "Expert reaction to announcement of a new NHS pilot on a blood test for more than 50 cancers".
  26. ↑ Campbell, Denis (November 27, 2020). "NHS to trial blood test to detect more than 50 forms of cancer". The Guardian. Retrieved November 28, 2020.
  27. ↑ "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.
  28. ↑ Nathan-Kazis, Josh (June 4, 2021). "Grail Will Begin Selling Its Multi-Cancer Blood Test". Barron's. Retrieved June 25, 2023.
  29. ↑ Johnson, Kate (January 10, 2023). "Cancer Clinics See Patients Demanding New Cancer Detection Tests". Medscape.
  30. ↑ Smyth, Jamie; Smith, Ian (June 2, 2023). "More than 400 Grail patients incorrectly told they may have cancer". Financial Times.
  31. ↑ Sunny, Mariam (June 2, 2023). "Grail says about 400 patients incorrectly informed they may have cancer". Reuters.
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