Company:Grail, Inc.

From HandWiki
GRAIL, Inc.
TypePublic
NASDAQ: GRAL
IndustryBiotechnology
Founded2015; 11 years ago (2015)
Headquarters
Menlo Park, California
,
United States
Key people
  • Joshua Ofman (CEO)
  • Harpal Kumar (president, Europe)[1]
ProductsGalleri test
RevenueIncrease US$126 million (2024)
Decrease US$−2.2 billion (2024)
Decrease US$−2.0 billion (2024)
Total assetsDecrease US$2.98 billion (2024)
Total equityDecrease US$2.50 billion (2024)
Number of employees
1,000 (2024)
Websitegrail.com
Footnotes / references
[2]

GRAIL, Inc. is an American biotechnology company based in Menlo Park, California founded in 2015 seeking to develop an early cancer screening test for people who do not have symptoms. As a startup it was a subsidiary of Illumina, which bought it outright in 2021.[3]

In June 2021, GRAIL launched their liquid biopsy, or multi-cancer early detection test, which they called Galleri test. In 2023, EU regulators ordered Grail to be spun-out from Illumina which was completed on June 24, 2024.[4]

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.[5] 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.[6]

Galleri test

As of November 2020, Galleri investigated three multi-cancer screening tests.[7][8]

In June 2021 Galleri launched their liquid biopsy or multi-cancer early detection test (MCED), which Grail called the Galleri test.[9] Grail promoted the test as a "groundbreaking and potentially life-saving advance", although the results of early trials were poor.[10] A subsequent large-scale NHS England trial was described as overhyped and unethical. As of 2024, Grail was facing discontent and legal action from investors.[10]

In June 2025, an article in the New Yorker discussed an interview of their medicine and science writer regarding the test and its recent history with a focus on its potential for adaptation as research continues in its product development through clinical investigations.[11]

On 17 October 2025, BBC news carried positive coverage of test results just presented at the European Society for Medical Oncology.[12] However, as of October 20, 2025 the results of the PATHFINDER 2 study have yet to be peer reviewed or published.[13] Eric Topol reported a sensitivity of only 40% these false negatives failed to discover cancer that emerged during the 12-month follow-up.[14]

Company 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.[5][15][16][17] 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.[18] He also joined Grail's board of directors.[19] According to Forbes in 2017, 20% of Grail's profits are kept by Illumina.[5]

In September 2020, Illumina announced an agreement to purchase Grail outright for $7.1 billion.[20]

On November 27, 2020, Grail announced a commercial partnership with the National Health Service (England) (NHS), to trial the Galleri test, reporting in 2026.[21][22]

In March 2021, the Federal Trade Commission (FTC) sued to block the vertical merger.[23][24] In September 2022, an administrative judge ruled against the FTC's position on antitrust grounds.[25]

In June 2023, Grail disclosed that letters were mailed to 408 patients incorrectly informing them that they may have cancer. The company blamed the incident on PWNHealth, saying that it was due to a software configuration issue, not due to incorrect Galleri test results.[26][27]

In October 2023, the European Commission ordered Grail to be divested from Illumina within the next twelve months.[28] The European Commission (EC) has since approved Illumina's divestment plan for separating from Grail. Illumina has set a goal of finalizing the divestment terms by the end of the second quarter of 2024. In April 2024, the EC approved Illumina's plan, allowing Illumina to explore either a trade sale or a capital markets transaction (spin-off) to divest Grail. In May 2024, Illumina publicly filed a Form 10 registration statement with the U.S. SEC, a necessary step for a potential capital markets separation of Grail. If a capital markets transaction occurs, Illumina must capitalize Grail with around $1 billion to fund 2.5 years of operations per the EC's divestment plan.[29][30][31] The spinoff was completed in June 2024, with Grail trading on the Nasdaq with ticker symbol GRAL and Illumina retaining a 14.5% share of Grail.[32]

References

  1. ↑ Bedingfield, Will (March 30, 2023). "This Blood Test Targets 50 Types of Cancer". Wired. https://www.wired.com/story/wired-health-grail-galleri-harpal-kumar-cancer-blood-test/. 
  2. ↑ "2024 Annual Report (Form 10-K)". U.S. Securities and Exchange Commission. March 5, 2025. https://www.sec.gov/ix?doc=/Archives/edgar/data/1699031/000169903125000041/gral-20241231.htm. 
  3. ↑ 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. https://books.google.com/books?id=XsEzDwAAQBAJ&pg=PA21. 
  4. ↑ Kelly, Susan (9 May 2025). "SEC ends probe of Illumina’s Grail acquisition" (in en). https://www.medtechdive.com/news/Illumina-SEC-ends-Grail-investigation-Q1/747691/. 
  5. ↑ 5.0 5.1 5.2 Herper, Matthew. "Company Will Raise $1 Billion To Create Blood Test To Detect Cancer" (in en). https://www.forbes.com/sites/matthewherper/2017/01/05/grail-which-aims-to-invent-blood-test-to-detect-cancer-to-raise-1-billion/. 
  6. ↑ 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. https://books.google.com/books?id=foY_DwAAQBAJ&pg=PT109. 
  7. ↑ 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. PMID 33200893. 
  8. ↑ The Lancet Oncology (1 June 2020). "Cancer detection: the quest for a single liquid biopsy for all" (in en). The Lancet Oncology 21 (6): 733. doi:10.1016/S1470-2045(20)30033-4. ISSN 1470-2045. PMID 32502435. 
  9. ↑ Pyzocha, Natasha J. (October 2022). "Galleri Test for the Detection of Cancer". American Family Physician 106 (4): 459–460. ISSN 1532-0650. PMID 36260909. https://www.aafp.org/pubs/afp/issues/2022/1000/diagnostic-tests-galleri-test-cancer.html. 
  10. ↑ 10.0 10.1 "Galleri promises to detect multiple cancers—but new evidence casts doubt on this much hyped blood test". BMJ 386. 7 August 2024. doi:10.1136/bmj.q1706. PMID 39111803. 
  11. ↑ Jocelyn, Hannah (June 17, 2025). "What if we could not only detect a cancer's presence but divine its intent?". https://link.newyorker.com/view/5be9ee5d24c17c6adf0abc2co0gu5.blvu/16b949e8. 
  12. ↑ "Galleri test: Exciting results from blood test for 50 cancers". BBC News. 17 October 2025. https://www.bbc.co.uk/news/articles/c205g21n1zzo. 
  13. ↑ GRAIL, Inc. (December 24, 2024). The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population (Report). clinicaltrials.gov. https://clinicaltrials.gov/study/NCT05155605. 
  14. ↑ Topol, Eric (October 20, 2025). "The Largest Study of a Multi-Cancer Early Detection Blood Test". https://erictopol.substack.com/p/the-largest-study-of-a-multi-cancer. 
  15. ↑ Rockoff, Jonathan D. (21 September 2020). "Sequencing Firm Illumina to Pay $7.1 Billion for Liquid-Biopsy Firm Grail" (in en-US). Wall Street Journal. ISSN 0099-9660. https://www.wsj.com/articles/sequencing-firm-illumina-to-pay-7-1-billion-for-liquid-biopsy-firm-grail-11600682402. 
  16. ↑ Novo Melo, Pedro; Machado, Carolina (2018). Management and Technological Challenges in the Digital Age. CRC Press. p. 157. ISBN 978-0-429-81623-9. https://books.google.com/books?id=ZJxYDwAAQBAJ&pg=PT157. 
  17. ↑ Kuchler, Hannah; Aliaj, Ortenca (21 September 2020). "Illumina agrees $8bn deal for cancer screening group Grail". Financial Times. https://www.ft.com/content/7a180e0a-9a88-43ed-b41f-19d2e360edfd. 
  18. ↑ Leuty, Ron (27 May 2021). "Biotech's elder statesman is still going strong". San Francisco Business Times. https://www.bizjournals.com/sanfrancisco/news/2021/05/27/rick-klausner-cancer-lyell-juno-grail-orca-nih-nci.html. 
  19. ↑ "Illumina Launches GRAIL, Focused on Blood-Based Cancer Screening". GEN - Genetic Engineering and Biotechnology News. 11 January 2016. https://www.genengnews.com/news/illumina-launches-grail-focused-on-blood-based-cancer-screening/. 
  20. ↑ Rockoff, Jonathan D. (21 September 2020). "Sequencing Firm Illumina to Pay $7.1 Billion for Liquid-Biopsy Firm Grail". Wall Street Journal. https://www.wsj.com/articles/sequencing-firm-illumina-to-pay-7-1-billion-for-liquid-biopsy-firm-grail-11600682402?mod=article_inline. 
  21. ↑ "NHS to pilot potentially revolutionary blood test that detects more than 50 cancers". 27 November 2020. https://www.england.nhs.uk/2020/11/nhs-to-pilot-potentially-revolutionary-blood-test/. 
  22. ↑ Smith-Spark, Laura (27 November 2020). "UK to pilot blood test that may detect 50 types of cancer" (in en). CNN. https://edition.cnn.com/2020/11/27/health/cancer-blood-test-pilot-gbr-intl. 
  23. ↑ Kendall, Brent; Rockoff, Jonathan D. (31 March 2021). "FTC Seeks to Block Illumina's $7.1 Billion Acquisition of Life Sciences Firm Grail". Wall Street Journal. https://www.wsj.com/articles/ftc-challenges-illuminas-proposed-acquisition-of-liquid-biopsy-firm-grail-11617131491. 
  24. ↑ "FTC Challenges Illumina's Proposed Acquisition of Cancer Detection Test Maker Grail" (in en). Federal Trade Commission. 30 March 2021. https://www.ftc.gov/news-events/press-releases/2021/03/ftc-challenges-illuminas-proposed-acquisition-cancer-detection. 
  25. ↑ Loftus, Peter (1 September 2022). "Illumina Wins Case Against FTC on Grail Acquisition". The Wall Street Journal. https://www.wsj.com/articles/illumina-wins-case-against-ftc-on-grail-acquisition-11662048056. 
  26. ↑ Smyth, Jamie; Smith, Ian (2 June 2023). "More than 400 Grail patients incorrectly told they may have cancer". Financial Times. https://www.ft.com/content/b91fc966-649e-4cd5-9e95-812987d27a51. 
  27. ↑ Sunny, Mariam (June 2, 2023). "Grail says about 400 patients incorrectly informed they may have cancer". Reuters. https://www.reuters.com/business/healthcare-pharmaceuticals/grail-says-over-400-patients-incorrectly-informed-they-may-have-cancer-2023-06-02/. 
  28. ↑ Chee, Foo Yun (12 October 2023). "Illumina ordered by EU antitrust regulators to sell Grail". Reuters. https://www.reuters.com/markets/deals/illumina-ordered-by-eu-antitrust-regulators-sell-grail-2023-10-12/. 
  29. ↑ "Illumina's planned divestment of GRAIL approved by the European Commission". 2024-05-06. https://www.illumina.com/company/news-center/press-releases/press-release-details.html?newsid=731555c3-06e8-4871-8b4a-51caefad4d20. 
  30. ↑ "Statement Regarding Illumina's Decision to Divest Grail". 2023-12-18. https://www.ftc.gov/news-events/news/press-releases/2023/12/statement-regarding-illuminas-decision-divest-grail. 
  31. ↑ "Illumina publicly files Form 10 registration statement ahead of planned divestiture of GRAIL". 2019-02-01. https://www.illumina.com/company/news-center/press-releases/press-release-details.html?newsid=c3d4df7d-9de2-45f6-a5c0-a55cee116fb0. 
  32. ↑ Steenhuysen, Julie (June 24, 2024). "Grail bets big on flagship cancer test after spin-off from Illumina". Reuters. https://www.reuters.com/business/healthcare-pharmaceuticals/grail-bets-big-flagship-cancer-test-after-spin-off-illumina-2024-06-24/. 



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