Frequently Asked Questions (FAQs)

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What is a blood-based screening test for colorectal cancer and how does it work?

A blood-based test, like Shield™, is optimized to accurately assess for DNA shed by tumors called circulating tumor DNA (ctDNA) to detect colorectal cancer through a simple blood draw. We apply a multimodal approach that analyzes genomic alterations, epigenomic modifications, and proteomics. Shield integrates these signals to produce an actionable result of either "abnormal signal detected" or "normal signal detected."1-4

Why is Guardant Health developing a blood-based approach for CRC detection?

Simply because patients who are not up to date with screening are at greater risk of CRC mortality.5 In fact, over 75% of people who died from CRC were not up to date with screening.5 CRC remains the second-leading cause of cancer-related deaths in the US.6 Sadly, over half of patients are diagnosed after their disease has spread and when survival rates are drastically lower.6-8 A blood-based approach can improve these statistics and increase patient compliance by overcoming barriers associated with available screening options–colonoscopy and stool-based testing.4

How can I order the Shield™ test?

Please call 1.855.722.7335 or email ScreeningSupport@guardanthealth.com to request more information.

How long does it take for Shield test results to be available?

We analyze Shield blood samples as soon as possible and deliver test results in ~2 weeks of receiving the samples in our lab.

As an employer, I am interested in offering a blood-based colorectal cancer screening program to my employees. Who do I contact?

Please email cancer@guardanthealth.com with your request and best contact information, and a Guardant Market Access team member will contact you.

What is the ECLIPSE trial and where can I find more information?

ECLIPSE is a registrational trial evaluating the performance of Guardant Health’s blood-based test in ~13,000 patients aged 45-84 with an average risk for CRC. The primary objective is to evaluate the performance of our test compared to screening colonoscopy. We expect data from this trial to support a submission to the FDA.9,10

More information can be found on guardanthealth.com/clinical-studies/.

How can I stay updated on the latest developments with Guardant Health’s blood-based CRC screening test or the ECLIPSE trial?

We’d be happy to keep you updated on the latest developments. Please sign up to stay up to date.

What preparations are necessary for a blood-based screening test?

No special preparations are needed for patients since a simple blood draw is all that is required. This means that patients do not need to make dietary changes, undergo sedation, or take extra time away from work or family.11

What are the current USPSTF recommendations for CRC screening?
  • The current USPSTF recommends screening for all eligible adults 45 to 75 years old for CRC12
  • The USPSTF does not identify any head-to-head studies demonstrating superiority of screening options. The goal is to maximize the total number of people who will be screened12
  • The USPSTF recommendations are classified into different grades below12
PopulationRecommendationGrade
Population
Adults aged
50 to 75 years
Recommendation
The USPSTF recommends screening for colorectal cancer in adults aged 50 to 75 years.
Grade
A
Population
Adults aged
45 to 49 years
Recommendation
The USPSTF recommends screening for colorectal cancer in adults aged 45 to 49 years.
Grade
B
Population
Adults aged
76 to 85 years
Recommendation
The USPSTF recommends that clinicians selectively offer screening for colorectal cancer in adults aged 76 to 85 years. Evidence indicates that the net benefit of screening all persons in this age group is small. In determining whether this service is appropriate for individual cases, patients and clinicians should consider the patient’s overall health, prior screening history, and preferences.
Grade
C

What financial assistance does Guardant Health provide?

Guardant Access is committed to making Shield accessible to all eligible patients.

For patients

  • Designed to limit surprise bills by notifying patients with an estimated out-of-pocket cost >$40
  • Eligible patients can receive financial assistance

For practices

  • We provide Shield—related eligibility confirmation, manage claims and appeals, and field all your patients´ billing questions

Any patient can enroll for financial assistance eligibility determination by signing the authorization form on GuardantGO.

Phone: 1.855.722.7335, ext. 1, then press 2

Email: ScreeningSupport@guardanthealth.com

Who should I contact if I have additional questions?

Please visit our contact us page to find out the best way to ask us additional questions.

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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
References1. 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. 2. 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 3. 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 4. 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 5. Doubeni CA, Fedewa SA, Levin TR, et al. Modifiable failures in the colorectal cancer screening process and their association with risk of death. Gastroenterology. 2019;156(1):63-74. doi:10.1053/j.gastro.2018.09.040 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. American Cancer Society. Colorectal cancer facts & figures 2017-2019. Accessed April 20, 2021. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2017-2019.pdf 8. National Cancer Institute. Colon and rectum stage distribution of SEER incidence cases, 2009-2018. Accessed November 10, 2021. https://seer.cancer.gov/explorer/application.html?site=20&data_type=1&graph_type=4&compareBy=sex&chk_sex_3=3&chk_sex_2=2&race=1&age_range=1&advopt_precision=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. 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 11. 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 12. Davidson KW, Barry MJ, Mangione CM, et al; US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238