Guardant Health’s SHIELD Test Now Available to Veterans Through Community Care Network
The Department of Veterans Affairs has approved coverage for Guardant Health’s SHIELD test, marking a significant expansion of access to the first FDA-approved blood test for colorectal cancer screening. The decision brings innovative early detection technology to the veteran community, addressing a critical healthcare gap where screening rates remain persistently low.
Revolutionary Blood-Based Cancer Detection
The SHIELD test represents a breakthrough in cancer screening technology, offering a simple blood draw alternative to traditional colonoscopy and stool-based tests. Sam Asgarian, Vice President of Clinical Development for Screening at Guardant Health, explains that the test works by detecting tumor DNA that cancer cells shed into the bloodstream as they multiply.
“Guardant Health started off a little over 12 years ago as a company focused on curing cancer with data,” Asgarian explained. “Recently, we researched, can we actually start detecting cancer in blood before the diagnosis? And we focused on colorectal cancer.”
“If a tumor is in the colon, that tumor is multiplying and has to shed some of its DNA when it’s multiplying into the bloodstream,” Asgarian said. “We can pick up that signal, even though it’s a small signal, because the tumor DNA is different from normal cellular DNA.”
The test achieved FDA approval following a comprehensive study involving more than 10,000 participants, with results published in the New England Journal of Medicine. Medicare beneficiaries have had access to the test for over a year through CMS coverage.
“We did a huge study with more than 10,000 people enrolled. We submitted the results of that study to the FDA. It was published in the New England Journal of Medicine,” Asgarian said. “And that got us approval for what’s called the SHIELD test. The SHIELD test is the first ever FDA-approved blood test that detects colorectal cancer in the blood.”
Addressing Critical Screening Gaps
Colorectal cancer remains the second leading cause of cancer death among Americans, claiming over 150,000 lives annually. Despite existing screening options, approximately 40% of eligible Americans—roughly 50 million people—remain unscreened for the disease.
The veteran population faces particular challenges with screening compliance. The VA’s decision to cover the SHIELD test acknowledges both the effectiveness demonstrated in the Medicare population and the urgent need to improve screening rates among veterans.
“A lot of people aren’t getting screened, and that’s very prevalent in the veterans community,” Asgarian noted. “It was really nice to see the VA lean in and say, ‘This is working for Medicare beneficiaries, it’s FDA approved, let’s cover this for veterans.'”
Simple Access Through Existing Healthcare Networks
Veterans can access the SHIELD test through any VA-authorized community care provider, following the same process as other colorectal cancer screening options. The test requires a physician’s order and is suitable for individuals aged 45 and older who haven’t been recently screened.
“This is just like any colorectal cancer screening option, it has to be ordered by a physician,” Asgarian explained. “They say, hey, I’m eligible. I’m 45 years or older, I haven’t been screened, I want to get the blood test, and then the doctor can write the order for SHIELD, and they can get it filled, getting the results back in as little as two weeks.”
The blood draw procedure is straightforward—requiring just four tubes of blood that can be collected during routine laboratory visits. “If you’re already ordering lab tests that are blood draws, you can order this as an additional lab test,” Asgarian noted. “It’s just an extra few tubes of blood.”
A negative result means no cancer was detected, and the patient won’t need additional colorectal cancer screening for three years unless symptoms develop. A positive result indicates the presence of tumor DNA, leading to diagnostic colonoscopy for precise tumor location and potential immediate treatment.
“If we don’t find cancer in the blood, it is a negative result. That patient doesn’t have to get tests or screened again for colorectal cancer as long as they’re not showing signs or symptoms for another three years,” Asgarian said. “If it is positive, if we see signs of tumor DNA in the blood, they get a positive result back. The other benefit of that is now, instead of a screening colonoscopy, you can do what’s called a diagnostic colonoscopy.”
Comprehensive Provider Support and Training
Guardant Health has deployed account executives and medical affairs representatives to educate VA community care network providers about test ordering and interpretation. Healthcare professionals receive comprehensive materials and can access additional resources at shieldcancerscreen.com.
The company leverages its extensive experience with cancer profiling tests to manage nationwide logistics, working directly with laboratory partners to ensure proper test kit availability and staff training. This infrastructure supports seamless integration into existing VA healthcare workflows.
Future Regulatory Milestones
Following FDA approval and expanding insurance coverage, Guardant Health is pursuing inclusion in guidelines from the United States Preventive Services Task Force (USPSTF). This federal advisory body, which meets every four to five years, is scheduled to reconvene in 2026 to evaluate new screening technologies.
USPSTF inclusion would potentially make the SHIELD test accessible to all Americans aged 45 and older, regardless of insurance coverage, alongside existing options like colonoscopy and stool-based tests.
Expanding Early Detection Technology
The SHIELD test represents the first application of Guardant Health’s broader strategy to revolutionize early cancer detection. Founded over 12 years ago with a mission to “cure cancer with data,” the company initially focused on helping oncologists select optimal treatments for diagnosed patients.
Asgarian, who brings a primary care background to his role, outlined ambitious plans to apply this blood-based detection technology to other cancers, including lung cancer (the leading cause of cancer death), pancreatic cancer, and liver cancer—diseases that currently lack effective screening options or face growing incidence rates.
The company also envisions expanding beyond cancer to detect chronic diseases like liver disease and diabetes in their early stages, potentially transforming preventive healthcare through simple blood tests.
“I’m a primary care provider by training and background, and I’ve always focused on these things about early detection and prevention,” Asgarian said. “We have a whole roadmap that we’re looking at where we can really take this technology and we can point it at more ways where we can find cancer early and give physicians an option to be more curative in their treatment for their patients.”
Looking beyond cancer screening, he added, “If we’ve done a good job at this, there’s no reason why we can’t point this towards chronic disease and find chronic disease like liver disease, you know, even things like diabetes that affect different organs. Can we find those earlier using this technology?”
Impact on Veteran Healthcare
The VA’s coverage decision reflects a broader commitment to providing veterans with access to cutting-edge medical technologies. For veterans who may have delayed or avoided traditional screening methods, the SHIELD test offers a convenient alternative that fits naturally into routine healthcare visits.
This development addresses both practical barriers to screening—such as the invasive nature of colonoscopy or the inconvenience of at-home stool tests—and represents a significant step toward improving early cancer detection rates in the veteran population.
As Guardant Health continues to expand access and develop additional applications for its technology, the SHIELD test’s inclusion in VA coverage marks a pivotal moment in the evolution of cancer screening, potentially serving as a model for broader adoption across the healthcare system.
