Frequently Asked Questions (FAQs)
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
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
We analyze Shield blood samples as soon as possible and deliver test results in ~2 weeks of receiving the samples in our lab.
The ECLIPSE clinical study is a large-scale colorectal cancer screening study that evaluates the performance of Shield, Guardant Health’s first blood-based test for the detection of early-stage CRC. A prospective, multi-site registrational study, ECLIPSE validated Shield in over 10,000 average-risk patients between the ages of 45 and 84 at over 200 sites across the US. The study demographics were generally reflective of the US population, with above-average enrollment among black Americans for a clinical study.9,10
The study demonstrated 83% sensitivity and 90% specificity for Shield, an easy-to-complete blood test.9,10
The data from this trial will be used to support a submission to the FDA and enable Centers for Medicare and Medicaid Services (CMS) coverage.
More information about ECLIPSE can be found at https://investors.guardanthealth.com/press-releases/press-releases/2022/Guardant-Health-announces-positive-results-from-pivotal-ECLIPSE-study-evaluating-a-blood-test-for-the-detection-of-colorectal-cancer/default.aspx
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
- 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
50 to 75 years
RecommendationThe USPSTF recommends screening for colorectal cancer in adults aged 50 to 75 years.
45 to 49 years
RecommendationThe USPSTF recommends screening for colorectal cancer in adults aged 45 to 49 years.
76 to 85 years
RecommendationThe 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.
Guardant Access is committed to making Shield accessible to all eligible patients.
- Designed to limit surprise bills by notifying patients with an estimated out-of-pocket cost >$50
- Eligible patients can receive financial assistance
- 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
Sign up to receive the latest updates on ShieldTM
- 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