Guardant Health’s Shield Blood Test Gains EviCore Coverage, Expanding Access to Colorectal Cancer Screening
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced that its Shield™ blood test for colorectal cancer (CRC) screening will be included in EviCore by Evernorth clinical guidelines effective January 1, 2027, in accordance with American Cancer Society (ACS) guidelines. The policy decision represents another significant step in the commercial expansion of Shield and is expected to broaden access to blood-based colorectal cancer screening for millions of eligible Americans.
EviCore, a Cigna-owned company, is the second-largest specialty benefits management organization in the United States and provides medical benefit management services to Blue Cross Blue Shield plans and other commercial payers across the country. Its updated coverage policy applies to payers across more than 23 states, potentially expanding access to Guardant Health’s FDA-approved blood-based screening option for average-risk adults.
The announcement comes as Guardant continues to see rapid commercial adoption of Shield. The latest EviCore policy update follows recent coverage expansions involving Carelon, described as the largest specialty benefits manager in the United States, as well as UnitedHealth Group, the country’s largest insurer. Together, these developments have increased the total number of covered lives for Shield to approximately 94 million.
Expanding Access to Blood-Based CRC Screening
Shield has emerged as a major innovation in colorectal cancer screening because it provides a blood-based option for average-risk adults who may otherwise be reluctant to complete traditional screening procedures.
The test is the first FDA-approved blood test for primary colorectal cancer screening in average-risk adults. Its inclusion in EviCore’s clinical guidelines is expected to make the test available to a broader population of individuals who meet recommended screening criteria.
Under the updated policy, people age 45 and older who are at average risk for colorectal cancer will have access to the blood-based screening option, providing another way for eligible individuals to participate in routine CRC screening.
The expansion comes against the backdrop of continued concern about colorectal cancer incidence and mortality, particularly among younger adults. Rates of colorectal cancer have been rising among adults younger than 65, while colorectal cancer has become a leading cause of cancer death among people under age 50.
These trends have increased the importance of identifying practical and accessible screening approaches that can help more people complete recommended screening.
EviCore Policy Extends Commercial Reach
EviCore’s clinical guidelines cover commercial payers operating across more than 23 states. The updated Shield policy therefore has the potential to affect access across a substantial portion of the U.S. healthcare market.
The policy applies to payers in Arkansas, Alabama, Connecticut, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland and Washington, D.C., Maine, Missouri, Minnesota, North Carolina, Nevada, New York, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Wisconsin, Wyoming and West Virginia.
For Guardant Health, the policy update represents another milestone in the company’s efforts to expand commercial coverage for Shield.
“With the latest coverage from EviCore, an overwhelming majority of eligible Americans now have access to the most clinically-validated blood-based colorectal cancer screening option,” said AmirAli Talasaz, Guardant Health co-CEO.
“Today’s expanded coverage from EviCore marks another critical milestone in our commercial expansion and rapid adoption by insurers as part of our broader mission to make screening more accessible for those who need it most,” Talasaz added.
The company believes broader insurance coverage can play an important role in increasing access to CRC screening and reducing barriers that may prevent eligible adults from completing recommended screening.
Addressing the Need for Earlier Detection
Colorectal cancer screening is intended to identify cancer and potentially precancerous disease before it progresses to more advanced stages. However, participation in screening remains a significant challenge across the U.S. healthcare system.
Traditional screening approaches can involve procedures or testing methods that some patients may find inconvenient, invasive, or difficult to complete. Blood-based screening offers an additional option that may be more acceptable to certain patients.
Guardant has positioned Shield as a way to make screening more accessible by integrating colorectal cancer screening into a familiar blood-draw experience.
The test is designed for average-risk adults and is now recommended in both ACS and National Comprehensive Cancer Network (NCCN) guidelines. The inclusion of Shield in these guidelines, combined with expanding commercial coverage, represents an important development in the adoption of blood-based CRC screening.
Shield’s Clinical Performance and Real-World Experience
Guardant said Shield has demonstrated the highest performance in colorectal cancer detection across all stages compared with published performance for fecal immunochemical testing (FIT).
The company has also accumulated substantial experience with Shield in routine clinical environments. More than 200,000 Shield tests have been performed in real-world settings, providing data on how the blood-based screening approach performs outside controlled clinical research environments.
According to Guardant, real-world use has demonstrated that Shield can significantly increase overall colorectal cancer screening completion among patients who are due for screening.
This increase in screening completion has been observed across different practice and health system settings, with the company reporting more than 90% screening adherence.
Such real-world adherence data are important because the effectiveness of any screening strategy depends not only on the analytical or clinical performance of the test, but also on whether eligible patients actually complete the screening process.
A screening test that patients are more willing and able to complete can potentially help healthcare providers address gaps in screening participation.
Commercial Adoption Continues to Accelerate
The EviCore policy decision is the latest development in a broader expansion of commercial coverage for Shield.
Guardant has reported rapid growth in covered lives during the most recent fiscal quarter, with additional coverage decisions from major healthcare organizations contributing to a total of approximately 94 million covered lives.
Carelon, the largest specialty benefits manager in the United States, recently expanded coverage for Shield. UnitedHealth Group, the largest insurer in the country, has also contributed to the growth in commercial access.
The addition of EviCore further expands the potential reach of the test by extending coverage across commercial payer networks in numerous states.
For Guardant, these developments demonstrate increasing recognition among insurers of the potential role of blood-based testing in improving CRC screening access.
Importance of Reaching Adults Starting at Age 45
The EviCore policy is particularly relevant to adults beginning at age 45, which is the age at which colorectal cancer screening is recommended for average-risk adults under current guidelines.
The expansion of screening eligibility to younger adults has become increasingly important as colorectal cancer trends change. Although colorectal cancer has historically been associated more strongly with older populations, incidence among younger adults has been increasing.
Mortality trends among younger patients have also raised concern, with colorectal cancer now identified as a leading cause of cancer death for individuals younger than 50.
These changes have increased the need for effective screening strategies that can reach eligible populations earlier and encourage sustained participation.
By providing a blood-based screening option, Shield is intended to offer another pathway for average-risk adults who need to be screened but may not complete other screening methods.
Integration Into Broader Precision Oncology Strategy
Guardant Health’s work on Shield forms part of its broader precision oncology strategy, which focuses on using blood-based testing and genomic information to support cancer detection, treatment, and monitoring.
The company has developed technologies intended to identify cancer-related signals through blood-based analysis. Shield extends that approach into the screening setting, where detecting colorectal cancer at an earlier stage may improve opportunities for intervention.
The commercial expansion of Shield also demonstrates the importance of reimbursement and payer adoption in translating diagnostic innovation into broader clinical use. Regulatory approval provides an important foundation for a diagnostic product, but widespread adoption depends heavily on whether patients can access the test through their healthcare providers and insurance coverage.
The EviCore policy update therefore represents more than an additional payer decision for Guardant. It contributes to the infrastructure required to make blood-based colorectal cancer screening more broadly accessible.
Coverage Across More Than 23 States
EviCore’s reach across multiple states gives the updated Shield policy considerable geographic significance.
The affected markets include Arkansas, Alabama, Connecticut, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland and the District of Columbia, Maine, Missouri, Minnesota, North Carolina, Nevada, New York, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Wisconsin, Wyoming and West Virginia.
Through its medical benefit management activities, EviCore works with Blue Cross Blue Shield organizations and other commercial payers. The addition of Shield to its clinical guidelines could therefore help expand access for eligible individuals across a diverse range of healthcare systems and insurance markets.
The coverage will become effective January 1, 2027.
A Growing Role for Blood-Based Screening
Guardant Health’s latest announcement reflects the broader evolution of colorectal cancer screening toward additional testing options that can help address barriers to participation.
With more than 200,000 Shield tests already performed in real-world settings and reported screening adherence exceeding 90%, the company is building a growing body of experience around blood-based CRC screening.
The inclusion of Shield in ACS and NCCN guidelines provides further support for its role within the evolving screening landscape, while expanding commercial coverage can help translate that recognition into greater patient access.
With the EviCore policy taking effect in January 2027 and total covered lives reaching approximately 94 million, Guardant Health is continuing to expand the commercial footprint of Shield.
The company’s focus remains on making colorectal cancer screening more accessible to eligible adults, particularly as healthcare providers and policymakers seek new approaches to address changing colorectal cancer incidence and mortality patterns.
The latest coverage expansion underscores the growing role that blood-based testing may play in the future of cancer screening and represents another step in Guardant Health’s efforts to increase participation in colorectal cancer screening across the United States.
About Shield
Shield is a methylation partitioning cell-free DNA (mp-cfDNA) non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.
About Guardant Health
Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer.