Guardant Health

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Guardant Health, Inc.
Company typePublic
Nasdaq: GH
IndustryBiotechnology
Founded2012; 12 years ago (2012)
Founders
Headquarters
Palo Alto, California
,
United States
Key people
  • Helmy Eltoukhy (co-CEO)
  • AmirAli Talasaz (co-CEO)
Number of employees
1,400 (2022)
Websiteguardanthealth.com

Guardant Health, Inc. is an American biotechnology company based in Palo Alto, California. Co-founders Helmy Eltoukhy and AmirAli Talasaz serve as co-chief executive officers.

History

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The American biotechnology company Guardant Health, which produces liquid biopsy tests to detect cancer from mutations and other modifications in blood samples,[1] was co-founded by Helmy Eltoukhy and AmirAli Talasaz during 2012–2013.[2][3] According to John Dorfman of the Pittsburgh Tribune-Review, Talasaz and Eltoukhy discovered a technique which "involves detecting and monitoring tumor fragments circulating in the patient's bloodstream", as an alternative to traditional tissue biopsies.[4] The duo met at Stanford University in 2002 and worked together at Illumina, until Talasaz left in 2012.[5]

Early in its history, Guardant Health acquired multiple patents by Swiss biochemist Maurice Stroun, who became a founding advisor.[6] In 2015, the company had 40 patents and was developing a blood test to "identify all classes of actionable tumor genomic alterations", according to VentureBeat. Guardant Health said the test would be the "first and only comprehensive biopsy-free cancer test available".[7] In 2016, the company announced clinical trial results demonstrating the test "detected disease-associated genetic mutations that were also present in 94% to 100% of the solid tissues extracted from the study's subjects".[8]

The company's U.S. initial public offering in 2018 raised $237.5 million,[9][10] valuing Guardant Health at $3.3 billion.[11] In December 2022, Guardant Health announced the results of a study on its blood-based screening test for colorectal cancers, which it began in 2019. The study included 20,000 participants identified as having an average risk for colorectal cancer. Results showed the test was 83 percent accurate at detecting the presence of cancer, with a 10 percent false positivity rate. Bloomberg reported that the results were short of the 85 percent accuracy rate that investors expected, and the company's stock price fell following the news. A competitor's stool-based test for the same cancer is 92 percent accurate.[12]

Funding

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Guardant Health raised approximately $550 million in funding in its first six years.[13][14] Aydin Senkut was an early investor.[15] The company raised $30 million in 2014,[16] including $10 million from Sequoia Capital.[17] In 2015, Guardant Health raised $50 million in a venture round led by Lightspeed Venture Partners. The funding was used for infrastructure and growing operations.[7] Guardant Health's Series D round in January 2017 raised approximately $100 million,[18][19] bringing total funding to $190 million.[20]

In 2017, the company raised $360 million in a round led by a subsidiary of SoftBank Group.[13][21] The funding supports an attempt to sequence the DNA of 1 million cancer patients in five years, bring to market a blood test to screen for early signs of cancer, and a blood test to detect residual disease in cancer survivors. Guardant Health and SoftBank formed the joint venture to expand the use of Guardant360 in Africa, Asia, and the Middle East.[3][20] The joint venture, called Guardant Health AMEA, launched in 2018 and was purchased by Guardant Health for approximately $178 million in 2022.[22]

Corporate affairs

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Business model and operations

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Guardant Health earns revenue from test fees purchased by third-party insurance companies and drug developers.[23] The company generated $374 million in revenue in 2021. Guardant Health has approximately 1,400 employees,[24] including approximately 900 in California, as of 2022.[2]

In July 2020, Guardant Health signed a lease for two levels at the former Hewlett Packard Enterprise headquarters in Palo Alto.[25] The lease agreement was the largest in Silicon Valley for the year to date,[26] and the company has since moved its corporate headquarters to the approximately 250,000-square-foot Palo Alto space.[25][27] The offices in Torrey Pines, San Diego are Guardant Health's largest outside Palo Alto and Redwood City at 37,000 square feet. The company has labs and 55 employees in San Diego as of 2022.[2][28]

Leadership

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Talasaz has served on Guardant Health's board of directors since January 2013, occupying the chairman role until August 2021.[29] He was the company's president and chief technology officer, as of 2014.[16][30] He held the president, chief financial officer, and chief operating officer positions in 2019, when he and Eltoukhy collectively held 12 percent of the company's stock.[23][31] In 2021, both spent $10 million to purchase additional shares of the company.[4]

Talasaz and Eltoukhy are co-chief executive officers as of 2022.[2] Richard B. Lanman joined in 2014 and was the chief medical officer (CMO) as of 2017.[6] Craig Eagle was named CMO in 2021.[32]

Products

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Guardant Health has partnered with the National Cancer Institute and large pharmaceutical companies on product improvement.[1] The business began selling Guardant360 tests to oncologists in 2014. Medicare began covering the test for select lung cancer patients in 2018, prior to Food and Drug Administration approval (which is not required)[7] in 2020.[33][34] By 2019, the Guardant360 genomic test, which requires two blood samples and examines 73 genes,[11][35][36] had been used for 50 types of cancer by 6,000 oncologists to assess samples from 100,000 patients.[37] The test had also been used by 50 biopharmaceutical companies for drug development purposes.[23] In late 2019, the Guardant360 test received expanded Medicare coverage for solid tumors.[38]

Guardant Health launched Project Lunar, which studied hundreds of "pre-symptomatic, high-risk" people for breast, colorectal, lung, ovarian, and pancreatic cancer, in May 2016 in collaboration with the University of California, San Francisco, the Seoul-based Samsung Medical Center, the University of Colorado, and the University of Pennsylvania.[6] The GuardantOMNI test launched in 2017 and has been used for biopharmaceutical research.[23] Guardant Health launched the early-stage cancer assay called Lunar for academic and biopharmaceutical research in 2019.[39]

Japan's Ministry of Health, Labour and Welfare granted regulatory approval of Guardant360 CDx as a companion diagnostic "for identifying patients with metastatic non-small cell lung cancer who may benefit from treatment with Lumakras (sotorasib)" in late 2021. The agency granted regulatory approval of the test in 2022 for patients with "advanced solid tumors" and as a companion diagnostic "to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda (pembrolizumab) and patients with MSI-High advanced colorectal cancer who may benefit from Opdivo (nivolumab)".[40]

In 2021, Guardant Health introduced Guardant Reveal, the first blood-only liquid biopsy test for the detection of residual and recurrent disease in colorectal cancer (CRC). The test helps oncologists improve the management of early-stage CRC patients by detecting circulating tumor DNA (ctDNA) in blood after surgery to identify patients with residual disease who may benefit most from adjuvant therapy, and by detecting recurrence earlier than current standard-of-care methods like carcinoembryonic antigen (CEA) tests or imaging.[41]

In 2022, Guardant Health enrolled the first patient in the Screening for High-Frequency Malignant Disease (SHIELD) Lung study to evaluate its blood-based screening technology for lung cancer.[42] Guardant Health also launched a colon cancer detection test called Shield.[43] The company partnered with the Vall d'Hebron Institute of Oncology to launch the first blood-based cancer testing services in Barcelona in mid 2022.[44] Guardant Health also licensed cancer tests to the clinical laboratory company Adicon for research testing in China.[45][46] In 2024 Guardant's Shield, colon cancer test received FDA approval.[47][48]

Litigation

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Guardant Health sued Foundation Medicine over patents in 2019–2020.[49][50] In 2021, Guardant Health licensed intellectual property to Foundation Medicine for $25 million in a settlement.[51] In 2022, Illumina sued Guardant Health and its co-founders in Delaware federal court over trade secrets. Illumina accused the duo of incorporating Guardant Health anonymously in 2011 while working at Illumina and stealing confidential documents related to DNA sequencing technology to acquire 35 patents.[5][52] In response, Guardant Health rejected the claims, accused Illumina of attempting to eliminate competitors, and asked for a suit dismissal.[53][54] In 2023, the two companies settled, signed a long-term supply agreement, and agreed to share specimen samples for cancer research.[27]

References

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  1. ^ a b Cha, Ariana Eunjung (April 28, 2016). "There's a new sheriff in town in Silicon Valley — the FDA". The Washington Post. Retrieved June 7, 2022.
  2. ^ a b c d Huard, Ray (April 28, 2022). "Guardant Health Scaling Up in San Diego". San Diego Business Journal. Retrieved June 2, 2022.
  3. ^ a b Bindi, Tas (May 11, 2017). "Guardant Health raises $360m to sequence tumour DNA from cancer patients". ZDNet. Retrieved June 7, 2022.
  4. ^ a b Dorfman, John (December 6, 2021). "John Dorfman: CEOs buy their own shares at loanDepot, Uber". Pittsburgh Tribune-Review. Retrieved June 2, 2022.
  5. ^ a b Brittain, Blake (March 17, 2022). "Illumina sues Guardant Health, founders over trade secrets". Reuters. Retrieved June 2, 2022.
  6. ^ a b c Medeiros, João (2017). "Marcus Krause's lung cancer wouldn't stop growing. Then he took a new kind of blood test". Wired UK. Retrieved September 6, 2022.
  7. ^ a b c Sullivan, Mark (February 3, 2015). "Guardant Health takes another $50M for 'liquid biopsy' cancer test". VentureBeat. Retrieved September 1, 2022.
  8. ^ Mukherjee, Sy (May 3, 2017). "This Simple Cancer Test Comes With a Big Caveat". Fortune. Retrieved September 6, 2022.
  9. ^ Schubarth, Cromwell (October 8, 2018). "A big hit and a big miss from pair of Silicon Valley life science IPOs". Silicon Valley Business Journal. Retrieved September 1, 2022.
  10. ^ Barinka, Alex (October 3, 2018). "SoftBank-Backed Guardant Soars in Trading Debut After U.S. IPO". Bloomberg.com. Retrieved September 1, 2022.
  11. ^ a b Herper, Matthew (November 12, 2018). "A $3 Billion Startup's Shares Gain On Hopes For A Cancer Blood Test". Forbes. Retrieved September 1, 2022.
  12. ^ Milton, Immanual John (December 15, 2022). "Guardant Health Plunges as Colorectal-Cancer Test Results Disappoint Investors". Bloomberg. Retrieved December 23, 2022.
  13. ^ a b Loizos, Connie (May 12, 2017). "Guardant Health adds $360 million to its war chest". TechCrunch. Retrieved September 1, 2022.
  14. ^ Leuty, Ron (September 8, 2018). "Two more Peninsula IPOs tell the story of biotech's investment boom". San Francisco Business Times. Retrieved September 1, 2022. Guardant, meanwhile, has raised $550 million since it was founded...
  15. ^ Simonds, Lauren (August 12, 2022). "Felicis, Lux Capital and Upfront Ventures tackle TAM at Disrupt". TechCrunch. Retrieved September 1, 2022.
  16. ^ a b Leuty, Ron (April 23, 2014). "Khosla, Sequoia back 'liquid biopsy' startup Guardant Health in $30 million round". San Francisco Business Times. American City Business Journals. Retrieved June 2, 2022.
  17. ^ Farr, Christina (February 15, 2014). "If it works, Guardant's new approach to detecting cancer may save your life". VentureBeat. Retrieved September 6, 2022.
  18. ^ Leuty, Ron (January 7, 2016). "'Liquid biopsy' company draws $100 million to sleuth out cancers". San Francisco Business Times. Retrieved September 6, 2022.
  19. ^ "Guardant Health Raises Nearly $100M in Series D Funding". GenomeWeb. January 7, 2016. Retrieved September 1, 2022.
  20. ^ a b Sawers, Paul (May 11, 2017). "Cancer screening firm Guardant Health raises $360 million to sequence tumor DNA of 1 million patients". VentureBeat. Retrieved September 1, 2022.
  21. ^ Herper, Matthew (May 11, 2017). "Guardant Health Raises $360 Million In Race To Create Cancer Blood Tests". Forbes. Retrieved September 1, 2022.
  22. ^ "Guardant Health Completes Purchase of Guardant Health AMEA Joint Venture". GenomeWeb. June 13, 2022. Retrieved September 6, 2022.
  23. ^ a b c d "Guardant Health Takes Aim at Exact Sciences". The Motley Fool. May 11, 2019. Retrieved June 2, 2022 – via Fox Business.
  24. ^ Wosen, Jonathan (April 22, 2022). "With milestones on the horizon, Guardant Health CEOs lay out their vision for cancer detection". Stat. Retrieved September 1, 2022.
  25. ^ a b Avalos, George (August 6, 2020). "Big lease: Guardant Health strikes deal for Palo Alto offices". The Mercury News.
  26. ^ Niksa, Matthew (August 7, 2020). "Cancer blood test developer Guardant Health signs Silicon Valley's largest office lease of 2020". Silicon Valley Business Journal. Retrieved September 1, 2022.
  27. ^ a b Brittain, Blake (August 3, 2023). "Guardant Health settles Illumina lawsuit over gene-sequencing technology". Reuters. Retrieved September 27, 2023.
  28. ^ Philippidis, Alex (August 9, 2022). "New Labs, New Funds: Activity Blossoms in the Leading U.S. Biopharma Clusters". Genetic Engineering and Biotechnology News. Retrieved September 1, 2022.
  29. ^ "AmirAli Talasaz". Bloomberg.com. Retrieved June 2, 2022.
  30. ^ Pollack, Andrew (April 7, 2014). "Sidestepping the Biopsy With New Tools to Spot Cancer". The New York Times. Retrieved June 2, 2022.
  31. ^ "New Lung Ambition Alliance Aims to Double Five-year Lung Cancer Survival by 2025". Imaging Technology News. July 17, 2019. Retrieved June 2, 2022.
  32. ^ Lim, David (May 7, 2021). "CDC's vaccine committee to weigh Pfizer shot for young teens". Politico. Retrieved October 4, 2022.
  33. ^ Weintraub, Karen (September 3, 2020). "'Coming into their own': FDA approval of liquid biopsy tests puts early, less invasive cancer detection in broader reach". USA Today. Retrieved September 6, 2022. The Food and Drug Administration approved Guardant360 CDx in early August for use in a range of solid tumors
  34. ^ Alpert, Bill (April 8, 2021). "How a Simple Blood Test Could Reduce Cancer Deaths". Barron's. Retrieved September 6, 2022.
  35. ^ Wordsworth, Rich (2017). "The simple blood test that could finally help cure cancer". Wired UK. Retrieved September 6, 2022.
  36. ^ Filice, Marco; Ruiz-Cabello, Jesus (February 26, 2019). Nucleic Acid Nanotheranostics: Biomedical Applications. Elsevier. p. 144. ISBN 9780128144718. Retrieved August 30, 2022.
  37. ^ Fox, Michelle (October 4, 2018). "Guardant Health soars almost 70% in first day of trading". CNBC. Retrieved September 6, 2022.
  38. ^ "Guardant Health Liquid Biopsy Test Gets Expanded Medicare Coverage for Solid Tumors". GenomeWeb. December 19, 2019. Retrieved September 6, 2022.
  39. ^ Philippidis, Alex (January 14, 2019). "Guardant Health Launches Blood-Based Early Cancer Assay for Research Use". Genetic Engineering and Biotechnology News. Retrieved September 1, 2022.
  40. ^ "Illumina Unveils Cancer Genomic Profiling Test". American Association for Clinical Chemistry. May 1, 2022. Retrieved September 1, 2022.
  41. ^ "Minimal Residual Disease Detection using a Plasma-only Circulating Tumor DNA Assay in Patients with Colorectal Cancer". Clinical Cancer Research. 27 (20). October 15, 2021.
  42. ^ Ford, Omar (January 18, 2022). "Guardant Enrolls Ist Patient in SHIELD Lung Study". Medical Device + Diagnostic Industry. Retrieved October 4, 2022.
  43. ^ Wosen, Jonathan (May 2, 2022). "Early cancer-detection market heats up as Guardant Health launches colon cancer test". Stat. Retrieved September 1, 2022.
  44. ^ Caffrey, Mary (July 2, 2022). "Researchers From Spain Find Option to Detect FGFR2 Fusion in Plasma". The American Journal of Managed Care. Retrieved September 1, 2022.
  45. ^ Pedersen, Amanda (July 6, 2022). "Guardant Licenses Cancer Tests to Chinese Lab". Medical Device + Diagnostic Industry. Retrieved October 4, 2022.
  46. ^ "Guardant Health Licenses Genomic Cancer Assays to Adicon for Testing in China". GenomeWeb. July 6, 2022. Retrieved October 4, 2022.
  47. ^ Edwards, Erika (29 July 2024). "FDA approves blood test to screen for colon cancer". NBC. Retrieved 30 July 2024.
  48. ^ Health, Center for Devices and Radiological (2024-10-08). "Shield – P230009". FDA.
  49. ^ Han, Andrew P. (January 6, 2020). "Guardant Health CEO Deleted Email Evidence After Lawsuit Deposition". GenomeWeb. Retrieved September 6, 2022.
  50. ^ Leuty, Ron (November 24, 2020). "Showdown over 'liquid biopsy' patents lands two cancer test players in court again". San Francisco Business Times. Retrieved September 1, 2022.
  51. ^ "Guardant Health to License IP to Foundation Medicine for $25M, Royalties Under Settlement Agreement". GenomeWeb. May 21, 2021. Retrieved September 6, 2022.
  52. ^ Wosen, Jonathan (March 17, 2022). "Illumina sues Guardant Health, saying former employees stole trade secrets to launch liquid biopsy firm". Stat. Retrieved September 1, 2022.
  53. ^ Wosen, Jonathan (May 26, 2022). "Guardant accuses Illumina of 'brazen' attempt to quash competition in ongoing legal battle". Stat. Retrieved September 1, 2022.
  54. ^ Leuty, Ron (May 27, 2022). "In cancer detection showdown, Guardant Health seeks dismissal of 'sham' Illumina lawsuit". San Francisco Business Times. Retrieved September 1, 2022.
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