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===Galleri test=== ===Galleri test===
Grail calls its ] 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.<ref name=Beer2020>{{Cite journal|last=Beer|first=Tomasz M.|date=1 November 2020|title=Novel blood-based early cancer detection: diagnostics in development|journal=]|volume=26|issue=14|pages=S292–S299|doi=10.37765/ajmc.2020.88533|pmid=33200893 |doi-access=free}}</ref><ref name=LancetJune2020>{{Cite journal|date=1 June 2020|title=Cancer detection: the quest for a single liquid biopsy for all|journal=The Lancet Oncology|language=en|volume=21|issue=6|pages=733|doi=10.1016/S1470-2045(20)30033-4|issn=1470-2045|pmid=32502435|doi-access=free|last1=The Lancet Oncology |pmc=7266566 }}</ref> The Galleri test detects ] in a blood sample via ], which identifies ], distinct patterns of which are associated with particular cancers, potentially allowing early detection of cancer and providing information of the origin of the cancer.<ref name=Beer2020/> Grail calls its ] 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.<ref name=Beer2020>{{Cite journal|last=Beer|first=Tomasz M.|date=1 November 2020|title=Novel blood-based early cancer detection: diagnostics in development|journal=]|volume=26|issue=14|pages=S292–S299|doi=10.37765/ajmc.2020.88533|pmid=33200893 |doi-access=free}}</ref><ref name=LancetJune2020>{{Cite journal|date=1 June 2020|title=Cancer detection: the quest for a single liquid biopsy for all|journal=The Lancet Oncology|language=en|volume=21|issue=6|pages=733|doi=10.1016/S1470-2045(20)30033-4|issn=1470-2045|pmid=32502435|doi-access=free|last1=The Lancet Oncology |pmc=7266566 }}</ref>


Despite Grail promoting the test as a “groundbreaking and potentially life-saving advance", the results of early trials were were poor.<ref name=hyped>{{cite journal |journal=BMJ |type=Investigation |vauthors=McCartney M, Cohen D |title=Galleri promises to detect multiple cancers—but new evidence casts doubt on this much hyped blood test |date=7 August 2024 |doi=}}</ref> 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.<ref name=hype/>
Grail's first clinical trial for the Galleri test is the 'Circulating Cell-free Genome Atlas Study'.<ref name="GlorikianBranca2017"/> 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.<ref name=Beer2020/> Subsequently the Galleri test entered into a further three trials; STRIVE, SUMMIT, and PATHFINDER studies.<ref name=Beer2020/> Results from PATHFINDER presented in September 2022 showed a 43.1% ] for the detection of early-stage cancer, with the test predicting the cancer signal origin with 97% accuracy in less than three months' time.<ref name="ESMO 2022">{{cite web |title=903O - A prospective study of a multi-cancer early detection blood test |url=https://oncologypro.esmo.org/meeting-resources/esmo-congress-2022/a-prospective-study-of-a-multi-cancer-early-detection-blood-test|website=ESMO Congress – OncologyPRO |access-date=26 July 2023 |date=11 September 2022}}</ref>

Galleri received breakthrough device designation from the U.S. ] in May 2019.<ref>{{cite news |last1=Tirumalaraju |first1=Divya |title=Grail gets FDA breakthrough designation for multi-cancer test |url=https://www.medicaldevice-network.com/news/grail-test-fda-breakthrough-status/ |access-date=26 June 2023 |work=Medical Device Network |date=14 May 2019}}</ref> The test does not diagnose cancer;<ref name="Health">{{cite news |title=The Galleri Blood Test: What To Know |url=https://www.health.com/condition/cancer/galleri-cancer-blood-test |access-date=26 July 2023 |work=Health |date=21 December 2022 |language=en}}</ref> rather, it detects possible signs of cancer in order to help direct follow-up diagnostic testing.<ref>{{cite news |last1=Sample |first1=Ian |title=Blood test spots multiple cancers without clear symptoms, study finds |url=https://www.theguardian.com/science/2022/sep/11/galleri-blood-test-multiple-cancers-before-clear-symptoms-study |access-date=26 July 2023 |work=The Guardian |date=11 September 2022}}</ref> Galleri is not yet approved by the FDA, but it is available by prescription under the agency's provision for ]s.<ref>{{cite news |last1=Kolata |first1=Gina |title=Blood Tests That Detect Cancers Create Risks for Those Who Use Them |url=https://www.nytimes.com/2022/06/10/health/cancer-blood-tests.html |access-date=25 June 2023 |work=The New York Times |date=10 June 2022}}</ref> <ref>{{cite news |last1=Sample |first1=Ian |title=Blood test spots multiple cancers without clear symptoms, study finds |url=https://www.theguardian.com/science/2022/sep/11/galleri-blood-test-multiple-cancers-before-clear-symptoms-study |access-date=26 July 2023 |work=The Guardian |date=11 September 2022}}</ref>

In November 2020 Grail announced a commercial partnership with the ] (NHS), to trial the Galleri test;<ref name=Ind2020>{{Cite news|date=27 November 2020|title=NHS to trial 'game-changer' blood test for cancer in 2021|last=Gregory|first=Andy|url=https://www.independent.co.uk/news/health/cancer-blood-test-nhs-galleri-grail-england-latest-b1762575.html|newspaper=The Independent|language=en}}</ref><ref name=NHS>{{Cite web|title=NHS England » NHS to pilot potentially revolutionary blood test that detects more than 50 cancers|url=https://www.england.nhs.uk/2020/11/nhs-to-pilot-potentially-revolutionary-blood-test/|access-date=30 November 2020|publisher=NHS England}}</ref> several scientists responded to the news.<ref name=ScMedia>{{Cite web|title=Expert reaction to announcement of a new NHS pilot on a blood test for more than 50 cancers|author=Several experts|url=https://www.sciencemediacentre.org/expert-reaction-to-announcement-of-a-new-nhs-pilot-on-a-blood-test-for-more-than-50-cancers/|date=27 November 2020|language=en-GB}}</ref><ref name=Campbell2020>{{Cite news|last=Campbell|first=Denis|date=27 November 2020|title=NHS to trial blood test to detect more than 50 forms of cancer|url=http://www.theguardian.com/science/2020/nov/27/nhs-to-trial-blood-test-to-detect-more-than-50-forms-of-cancer|access-date=28 November 2020|newspaper=The Guardian|language=en}}</ref>

The NHS England interventional ] 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.<ref name=Ind2020/> The trial started on August 31, 2021, with primary completion date estimated at July 15, 2024, and study completion on February 28, 2026.<ref>{{cite journal | title=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 | website=ClinicalTrials.gov | date=10 November 2022 | url=https://clinicaltrials.gov/ct2/show/NCT05611632|id=NCT05611632}}</ref> In June 2021, the company began selling Galleri tests in the U.S.<ref>{{cite news |last1=Nathan-Kazis |first1=Josh |title=Grail Will Begin Selling Its Multi-Cancer Blood Test |url=https://www.barrons.com/articles/grail-multi-cancer-blood-test-51622812135 |access-date=25 June 2023 |work=Barron's |date=4 June 2021}}</ref>

{{As of|2023|1}} 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.<ref>{{cite news| last=Johnson | first=Kate | title=Cancer Clinics See Patients Demanding New Cancer Detection Tests | website=Medscape | date=10 January 2023 | url=https://www.medscape.com/viewarticle/986779}}</ref>


== References == == References ==

Revision as of 14:57, 8 August 2024

American health care company

GRAIL
File:Grail logo.png
Company typePublic
Traded asNasdaq: GRAL
IndustryBiotechnology
Founded2015; 10 years ago (2015)
HeadquartersMenlo Park, California, United States
ProductsGalleri test
Websitegrail.com

Grail (styled GRAIL) is an American biotechnology company 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) 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. 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.

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 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.

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. ^ 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. Smyth, Jamie; Smith, Ian (June 2, 2023). "More than 400 Grail patients incorrectly told they may have cancer". Financial Times.
  14. Sunny, Mariam (June 2, 2023). "Grail says about 400 patients incorrectly informed they may have cancer". Reuters.
  15. Smyth, Jamie; Kinder, Tabby (July 13, 2023). "Grail sued by three female ex-employees over 'toxic work culture'". Financial Times.
  16. Chee, Foo Yun (October 12, 2023). "Illumina ordered by EU antitrust regulators to sell Grail". Reuters.
  17. "Illumina's planned divestment of GRAIL approved by the European Commission". Illumina. May 6, 2024.
  18. "Statement Regarding Illumina's Decision to Divest Grail". Federal Trade Commission. December 18, 2023.
  19. "Illumina publicly files Form 10 registration statement ahead of planned divestiture of GRAIL". Illumina. February 1, 2019.
  20. 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.
  21. 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.
  22. 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.
  23. 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).
  24. Cite error: The named reference hype was invoked but never defined (see the help page).

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