Guardant Health has
advanced our technology
to include screening for early
CRC detection1,2

Guardant Health logo.

For a decade, Guardant Health has been dedicated to supporting patients with cancer across the continuum of care3

Our blood-based technology detects cancer signals in the blood, including CRC1,2
  • SCREENING AND EARLY DETECTION*

    Shield Logo

    Diagnosis

    ECLIPSE TRIAL

    A registrational trial of ~13,000 average-risk patients to validate a blood-based screening test for CRC5

  • EARLY-STAGE CANCER*

    Residual disease detection
    and recurrence surveillance (commercially available since 20213)

    Guardant Reveal logo.

    Surgery

    Recurrence

  • ADVANCED CANCER*

    Treatment selection and optimization (commercially available since 20143,4†)

    FDA Approved Guardant360® CDx logo.Guardant360® TissueNext logo.Guardant360® Response logo.Guardant360® logo.

    Progression

    200,000 patients tested & 260+ peer-reviewed publications3

  • In early- and late-stage cancer

    National Cancer Institute and National Comprehensive Cancer Network cancer centers use Guardant Health’s existing blood-based tests to inform treatment decisions for patients with early- and late-stage cancer 3

*Disclaimer: Shield, Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 tests were developed, and their performance characteristics determined, by the Guardant Health Clinical Laboratory in Redwood City, CA, USA, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical testing. Guardant360 refers to Guardant360 Laboratory Developed Test (LDT). These tests have not been cleared or approved by the US FDA.

Guardant360 has been commercially available since 2014.3

Patient timeline shown for illustrative purposes only.

See how we are
working to give
patients with cancer
more time1,6

Now, we have developed an accurate blood-based test, Shield™, that can increase CRC screening compliance1,2,7

We have developed an accurate blood-based CRC screening test that fits right in. Shield can be completed at any patient visit and can increase the number of patients who get screened.1,2,7

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Shield™ is a qualitative laboratory developed test intended to detect colorectal neoplasia by identifying genomic and epigenomic alterations in cell-free DNA and proteomic changes in plasma from blood collected in Guardant blood collection tubes.
  • The assay is intended to be complementary to and not a replacement for current recommended colorectal cancer screening methods
  • Patients with an "abnormal signal detected" Shield test result should be referred for colonoscopic evaluation
  • A "normal signal detected" Shield test result does not preclude the presence of colorectal neoplasia, and patients should continue participating in guideline-recommended screening programs
  • Shield was developed, and its performance characteristics determined, by the Guardant Health Clinical Laboratory in Redwood City, CA, USA, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical testing. This test has not been cleared or approved by the US FDA
References 1. Kim ST, Raymond VM, Park JO, et al. Combined genomic and epigenomic assessment of cell-free circulating tumor DNA (ctDNA) improves assay sensitivity in early-stage colorectal cancer (CRC). Cancer Res. 2019;79(suppl 13):916. doi:10.1158/1538-7445.AM2019-916 2. Westesson O, Axelrod H, Dean J, et al. Integrated genomic and epigenomic cell-free DNA (cfDNA) analysis for the detection of early-stage colorectal cancer. Cancer Res. 2020;80(suppl 16):2316. doi:10.1158/1538-7445.AM2020-2316 3. Data on file. Guardant Health, Inc. 4. Guardant Health reaches target enrollment of 12,750 patients in ECLIPSE pivotal study for its LUNAR™-2 blood test to detect colorectal cancer. News release. Guardant Health, Inc; December 17, 2021. Accessed March 17, 2022. https://investors.guardanthealth.com/press-releases/press-releases/2021/Guardant-Health-Reaches-Target-Enrollment-of-12750-Patients-in-ECLIPSE-Pivotal-Study-for-its-LUNAR-2-Blood-Test-to-Detect-Colorectal-Cancer/default.aspx 5. US Food and Drug Administration. Guardant360® CDx approval letter. August 2020. https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200010A.pdf. Accessed March 18, 2022. 6. American Society of Clinical Oncology. Colorectal cancer: statistics. Cancer.net website. Updated January 2021. Accessed May 10, 2021. https://www.cancer.net/cancer-types/colorectal-cancer/statistics 7. Adler A, Geiger S, Keil A, et al. Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colonoscopy in Germany. BMC Gastroenterol. 2014;14:183. doi:10.1186/1471-230X-14-183