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GRAIL
Company typeSubsidiary
IndustryBiotechnology
FoundedJanuary 2016; 8 years ago (2016-01)
Headquarters
Menlo Park, California
,
United States
ProductsGalleri test
ParentIllumina, Inc.
Websitegrail.com

Grail (styled GRAIL) is an American biotechnology company, which began in 2016 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.

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

Background

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Grail began as a San Francisco biotechnology and pharmaceutical startup company in 2016,[2] 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] Dr. Richard Klausner, then chief medical officer at Illumina and former director of the National Cancer Institute, championed the new business[7] and joined its 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] In March 2021, the Federal Trade Commission sued to block the vertical merger.[10][11] In September 2022, an administrative judge ruled against the FTC's position on antitrust grounds.[12]

The company sponsored the Galleri Classic golf tournament in Rancho Mirage, California, in March 2023.[13]

Activities

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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

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Technology

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Grail calls its multi-cancer early detection test the Galleri 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 predicting the origin of the cancer.[15]

Galleri received breakthrough device designation from the U.S. Food and Drug Administration in May 2019.[17] The test does not diagnose cancer; rather, it detects possible signs of cancer in order to help direct follow-up diagnostic testing.[13] Galleri is not yet approved by the FDA, but it is available by prescription under the agency's provision for laboratory developed tests.[18][19]

Research

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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.[20] The study found that the number of cancer detections doubled when multi-cancer screening was included in the standard of care screening, compared to using only standard screening. The test also predicted the cancer signal origin with 97% accuracy.[21] Of the more than 6,000 participants in PATHFINDER, 35 were diagnosed with cancer, and 71% of those diagnosed were diagnosed with cancer types for which no routine screening is available.[22]

In November 2020 Grail announced a commercial partnership with the National Health Service (England) (NHS), to trial the Galleri test;[23][24][25] several scientists responded to the news.[26][27]

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][24] The trial started on August 31, 2021, with primary completion date estimated at July 15, 2024, and study completion on February 28, 2026.[28] In a separate NHS trial in collaboration with Oxford University, the SYMPLIFY study is evaluating the test's utility for symptomatic individuals.[29] Initial results shared in June 2023 showed that the test correctly detected two out of three cancers among 5,000 individuals who presented with symptoms. The test also accurately predicted the cancer signal origin in 85% of those cases.[30]

In May 2021, Grail announced that Providence Health & Services would be the first health system in the U.S. to offer access to the Galleri test.[31] The next month, the company began selling Galleri tests in the U.S., making it the first commercially available multi-cancer early detection test.[32] Point32Health, parent of Tufts Health Plan and Harvard Pilgrim Health Care, became the first commercial insurance provider to offer the test in November 2022.[33]

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.[34]

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.[35][36] Grail stated that more than half of the people who received erroneous letters had not yet had their blood drawn for the test.[37]

References

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  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. ^ Terry, Mark (January 9, 2017). "What You Need to Know About GRAIL". BioSpace. Retrieved June 26, 2023.
  3. ^ a b c 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. ^ a b Bohannan, Larry (March 23, 2023). "PGA Tour Champions tourney spreads word on Galleri early cancer detection test". The Desert Sun. Retrieved June 25, 2023.
  14. ^ a b 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. ^ a b c d 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. ^ Tirumalaraju, Divya (May 14, 2019). "Grail gets FDA breakthrough designation for multi-cancer test". Medical Device Network. Retrieved June 26, 2023.
  18. ^ 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.
  19. ^ Hale, Conor (June 7, 2021). "Grail launches long-awaited Galleri blood test, its groundbreaking multi-cancer screening diagnostic". Fierce Biotech. Retrieved June 26, 2023.
  20. ^ Longworth, Catherine (September 22, 2022). "ESMO shines a light on early cancer detection difficulties". Medical Device Network. Retrieved June 25, 2023.
  21. ^ Sidharthan, Chinta (September 13, 2022). "Final results of the PATHFINDER study by GRAIL on multi-cancer early detection tests announced". News-Medical.net. Retrieved June 25, 2023.
  22. ^ Barndollar, Hadley (October 27, 2022). "Multi-cancer early detection tests could save lives, but we still have a lot to learn". The Providence Journal. Retrieved June 25, 2023.
  23. ^ a b "GRAIL And UK Government To Make Galleri Multi-Cancer Early Detection Blood Test Available To Patients". thepharmadata.com. Retrieved November 27, 2020. [permanent dead link‍]
  24. ^ a b Gregory, Andy (November 27, 2020). "NHS to trial 'game-changer' blood test for cancer in 2021". The Independent.
  25. ^ "NHS England » NHS to pilot potentially revolutionary blood test that detects more than 50 cancers". NHS England. Retrieved November 30, 2020.
  26. ^ Several experts (November 27, 2020). "Expert reaction to announcement of a new NHS pilot on a blood test for more than 50 cancers".
  27. ^ Campbell, Denis (November 27, 2020). "NHS to trial blood test to detect more than 50 forms of cancer". The Guardian. Retrieved November 28, 2020.
  28. ^ "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.
  29. ^ "Multi-cancer blood test shows real promise in NHS trial". University of Oxford. June 2, 2023. Retrieved June 25, 2023.
  30. ^ Roberts, Michelle (June 1, 2023). "Multi-cancer blood test shows real promise in NHS study". BBC News. Retrieved June 25, 2023.
  31. ^ Nelson, Roxanne (May 17, 2021). "Blood Test for 50 Cancers Coming to US Clinics Soon". Medscape. Retrieved June 25, 2023.
  32. ^ Nathan-Kazis, Josh (June 4, 2021). "Grail Will Begin Selling Its Multi-Cancer Blood Test". Barron's. Retrieved June 25, 2023.
  33. ^ Johnston, Katie (November 27, 2022). "Point32Health evaluating blood test benefit to screen for 50 types of cancer - The Boston Globe". The Boston Globe. Retrieved June 25, 2023.
  34. ^ Johnson, Kate (January 10, 2023). "Cancer Clinics See Patients Demanding New Cancer Detection Tests". Medscape.
  35. ^ Smyth, Jamie; Smith, Ian (June 2, 2023). "More than 400 Grail patients incorrectly told they may have cancer". Financial Times.
  36. ^ Sunny, Mariam (June 2, 2023). "Grail says about 400 patients incorrectly informed they may have cancer". Reuters.
  37. ^ Holpuch, Amanda (June 4, 2023). "Hundreds Were Mistakenly Told They Might Have Cancer, Test Company Says". The New York Times. Retrieved June 25, 2023.
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