Blood-based CRC screening fits right in.
Simply done.

Rack of test tubes with blood.

ShieldTM is a blood-based test that can be completed at any patient visit1,2

A blood-based approach is the patient-preferred screening option for CRC3*

Patients icon.

This option fits into patients’ schedules and breaks through screening
barriers since it requires4

No special preparation
No dietary changesNo sedation
No sedationNo dietary changes
No extra time away
from family or work
Doctor icon.

It also fits right into a provider’s practice

If providers can order a complete blood count for their patients, they’re equipped to order
a blood-based CRC screening test.3

Shield is now available to order

Shield detects CRC with high accuracy1,2,5

86-94%
sensitivity5†
(CRC Stages I-III)
92%
specificity5†

And advanced adenomas were detected with 20% sensitivity5†

These data add to a growing body of evidence that demonstrates the high sensitivity of our blood-based technology5

1,784 individuals were evaluated in 2021 using our blood-based screening technology in 2 studies, which were presented at ASCO and ACG.5,6,7‡

We are currently conducting a registrational trial, ECLIPSE, to further validate our technology8

The trial aims to enroll ~13,000 patients (ages 45-84) at average risk for CRC.9

How Guardant Health’s blood-based approach identifies CRC1,2§

Our technology achieves high sensitivity by applying a multimodal approach to detect CRC signals in the bloodstream, including DNA that is shed by tumors.1,2,10

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*In a study, patients who initially refused colonoscopy preferred screening with a blood-based test over a stool-based test 83% vs 15%, respectively.3

In a study of 309 patients, sensitivity was 94% in Stages I-II, 86% in Stage III (91% overall), 20% in advanced adenomas, and specificity was 92%.5

2021 American Society of Clinical Oncology and 2021 American College of Gastroenterology.

§The assay is intended to be complementary to and not a replacement for current recommended colorectal cancer screening methods.
Patients with an abnormal blood-based screening result should be referred for colonoscopic evaluation.

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. 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 4. Rich T, Raymond V, Lang K. Where are we today? Efforts to understand strategies and barriers to physician issuance of a recommendation for colorectal cancer screening: a systematic review. Gastroenterology. 2020;158(6 suppl 1):S-918. doi:10.1016/S0016-5085(20)32981-4 5. Data on file. Guardant Health, Inc. 6. Lee J, Kim HC, Kim ST, et al. Multimodal circulating tumor DNA (ctDNA) colorectal neoplasia detection assay for asymptomatic and early-stage colorectal cancer (CRC). J Clin Oncol. 2021;39(suppl 15):3536. 7. Kim HC, Kim ST, He Y, et al. Multimodal circulating tumor DNA blood-based colorectal cancer screening test demonstrates clinically meaningful sensitivity across multiple clinical parameters. Published online October 22, 2021. Accessed March 1, 2022. https://guardanthealth.com/wp-content/uploads/2021_Lee_et_al_ACG_Oral_Abstract_24.pdf 8. Evaluation of the ctDNA LUNAR test in an average patient screening episode (ECLIPSE). ClinicalTrials.gov identifier: NCT04136002. Updated September 22, 2021. Accessed November 24, 2021. https://clinicaltrials.gov/ct2/show/NCT04136002?term=NCT04136002&draw=2&rank=1 9. Guardant Health. Second quarter 2021 earnings call. Published August 5, 2021. Accessed November 10, 2021. https://s26.q4cdn.com/594050615/files/doc_financials/2021/q2/final-080521-guardant-health-q2-2021-earnings-call.pdf 10. Dean J, He Y, Raymond V, et al. Plasma based cell-free circulating tumor DNA (ctDNA) assessment for non-invasive detection of colorectal cancer (CRC). Gastroenterology. 2020;158(6 suppl 1):S-369. doi:10.1016/S0016-5085(20)31616-4