Guardant Health's Shield MCD Test Selected for National Cancer Institute's Vanguard Study

Strategic Insights -

Guardant Health's Shield Multi-Cancer Detection (MCD) test has been selected for use in the National Cancer Institute's (NCI) Vanguard Study, a four-year study that aims to enroll up to 24,000 patients to evaluate the use of MCD tests in future randomized controlled trials. The study follows the review and approval by the U.S. Food and Drug Administration (FDA) as part of the NCI's submission for an investigational device exemption (IDE). The Vanguard Study will assess the effectiveness of MCD tests in detecting multiple types of cancer, including lung, breast, colorectal, prostate, bladder, ovarian, pancreatic, esophageal, liver, and gastric cancers.

Key Takeaways:

  • The Vanguard Study aims to enroll up to 24,000 patients and evaluate the use of MCD tests in future randomized controlled trials.
  • Guardant's Shield MCD test was chosen for the study based on its overall performance in detecting 10 cancer types, including lung, breast, colorectal, prostate, bladder, ovarian, pancreatic, esophageal, liver, and gastric cancers.
  • The Shield MCD test has received Breakthrough Device Designation from the FDA for the multi-cancer screening of multiple cancer types, including bladder, colorectal, esophageal, gastric, liver, lung, ovarian, and pancreas cancer in individuals aged 45 or older.
  • The Vanguard Study is a critical step in research to evaluate the role of MCD technology in helping reduce cancer deaths.
  • The study aims to learn more about MCD tests and assess whether they can help people from all backgrounds find cancer early, when it may be easier to treat.
  • Craig Eagle, MD, Guardant Health Global Chief Medical Officer, emphasizes the potential of MCD technology to detect multiple cancers earlier through a simple blood draw, unlocking more treatment options and potentially saving lives.
  • The study is being led by Scott Ramsey, M.D., Ph.D., director of the Hutchinson Institute for Cancer Outcomes Research at Fred Hutch Cancer Center and principal investigator for the Vanguard Study.

Statistics:

  • 10 cancer types: lung, breast, colorectal, prostate, bladder, ovarian, pancreatic, esophageal, liver, and gastric cancers will be evaluated by the Shield MCD test.
  • 24,000 patients will be enrolled in the four-year Vanguard Study.
  • The study is selecting participants aged 45-75 who do not currently have cancer and have not received a cancer diagnosis in the past five years.
  • Breakthrough Device Designation has been granted for the screening of multiple cancer types, including bladder, colorectal, esophageal, gastric, liver, lung, ovarian, and pancreas cancer in individuals aged 45 or older.

Sources:

  • "Guardant Health, Inc. Announces Patient Enrollment Has Begun in the National Cancer Institute's Vanguard Study to Evaluate Emerging Multi-Cancer Detection Technology." Guardant Health, Inc., 2023.
  • American Society of Clinical Oncology (ASCO) Annual Meeting.
  • "Breakthrough Devices Program." U.S. Food and Drug Administration, 2023.
  • Cancer Screening Research. National Cancer Institute.