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Grail (company)

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American health care company

GRAIL, Inc.
Company typePublic
Traded asNasdaq: GRAL
IndustryBiotechnology
Founded2015; 9 years ago (2015)
HeadquartersMenlo Park, California, United States
Key people
ProductsGalleri test
Websitegrail.com

GRAIL, Inc. is an American biotechnology company based in Menlo Park, California. It was previously a subsidiary of Illumina started as a startup seeking to develop an early cancer screening test for people who do not have symptoms. Grail was spun-out from Illumina on June 24, 2024.

Their liquid biopsy (also called multi-cancer early detection test) was launched in June 2021 and is called the Galleri test. Promoted as groundbreaking, the test performed poorly in testing and Grail has subsequently faced discontent and legal action from investors claiming they have been misled about the test's potential.

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. 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.

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 which was under investigation as of November 2020.

Despite Grail promoting the test as a "groundbreaking and potentially life-saving advance", the results of early trials were poor. A subsequent large-scale NHS England trial has been described by experts as overhyped and unethical. Grail is facing discontent and legal action from investors who suspect that its cancer testing claims misled them.

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. 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. He also joined Grail's board of directors. According to Forbes in 2017, 20% of Grail's profits are kept by Illumina.

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

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. In September 2022, an administrative judge ruled against the FTC's position on antitrust grounds.

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.

In July 2023, it was reported that three separate lawsuits were filed against Grail by former female employees; the allegations included that Grail created a "frat house” culture and a “sexually charged, hostile work environment”.

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

References

  1. ^ Steenhuysen, Julie (June 24, 2024). "Grail bets big on flagship cancer test after spin-off from Illumina". Reuters. Retrieved September 12, 2024.
  2. Bedingfield, Will (March 30, 2023). "This Blood Test Targets 50 Types of Cancer". Wired.
  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.
  4. Pyzocha, Natasha J. (October 2022). "Galleri Test for the Detection of Cancer". American Family Physician. 106 (4): 459–460. ISSN 1532-0650. PMID 36260909.
  5. ^ McCartney M, Cohen D (August 7, 2024). "Galleri promises to detect multiple cancers—but new evidence casts doubt on this much hyped blood test". BMJ (Investigation). doi:10.1136/bmj.q1706.
  6. ^ Herper, Matthew. "Company Will Raise $1 Billion To Create Blood Test To Detect Cancer". Forbes. Retrieved November 27, 2020.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. Novo Melo, Pedro; Machado, Carolina (2018). Management and Technological Challenges in the Digital Age. CRC Press. p. 157. ISBN 978-0-429-81623-9.
  12. Kuchler, Hannah; Aliaj, Ortenca (September 21, 2020). "Illumina agrees $8bn deal for cancer screening group Grail". ft.com. Financial Times. Retrieved December 1, 2020.
  13. Leuty, Ron (May 27, 2021). "Biotech's elder statesman is still going strong". San Francisco Business Times. Retrieved June 25, 2023.
  14. "Illumina Launches GRAIL, Focused on Blood-Based Cancer Screening". GEN - Genetic Engineering and Biotechnology News. January 11, 2016. Retrieved June 25, 2023.
  15. 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.
  16. 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.
  17. "FTC Challenges Illumina's Proposed Acquisition of Cancer Detection Test Maker Grail". FTC.gov. Federal Trade Commission. March 30, 2021. Retrieved March 31, 2021.
  18. Loftus, Peter (September 1, 2022). "Illumina Wins Case Against FTC on Grail Acquisition". The Wall Street Journal.
  19. Smyth, Jamie; Smith, Ian (June 2, 2023). "More than 400 Grail patients incorrectly told they may have cancer". Financial Times.
  20. Sunny, Mariam (June 2, 2023). "Grail says about 400 patients incorrectly informed they may have cancer". Reuters.
  21. Smyth, Jamie; Kinder, Tabby (July 13, 2023). "Grail sued by three female ex-employees over 'toxic work culture'". Financial Times.
  22. Chee, Foo Yun (October 12, 2023). "Illumina ordered by EU antitrust regulators to sell Grail". Reuters.
  23. "Illumina's planned divestment of GRAIL approved by the European Commission". Illumina. May 6, 2024.
  24. "Statement Regarding Illumina's Decision to Divest Grail". Federal Trade Commission. December 18, 2023.
  25. "Illumina publicly files Form 10 registration statement ahead of planned divestiture of GRAIL". Illumina. February 1, 2019.

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