Guardant Health announced that its Shield colorectal cancer screening blood test will now be available for physician order through Quest Diagnostics’ nationwide test‑ordering and collection network. The announcement was made on March 10, 2026. Shield is the first FDA‑approved blood test for primary colorectal cancer screening and has met Medicare coverage requirements, including Advanced Diagnostic Laboratory Test (ADLT) status that raises the Medicare reimbursement rate to $1,495 per test from $920.
Quest Diagnostics operates one of the largest diagnostic ecosystems in the United States, serving nearly 650,000 clinician and hospital accounts each year and operating about 2,000 patient service centers staffed by roughly 6,000 in‑office phlebotomists. By integrating Shield into this network, Guardant Health can reach a substantially larger patient and physician base, accelerating test uptake and driving revenue growth.
The partnership is expected to expand Guardant’s market share in the colorectal cancer screening market, where Shield’s FDA approval and Medicare coverage give it a competitive edge over existing stool‑based tests such as Exact Sciences’ Cologuard. Shield’s clinical performance shows a sensitivity of 55–65% for Stage I colorectal cancer and detects only about 11–12% of advanced adenomas, highlighting both its strengths and limitations.
Management emphasized the strategic importance of the collaboration. AmirAli Talasaz, co‑CEO, said, “Activating our strategic collaboration with Quest marks a pivotal milestone in broadening access to Shield and empowering primary care physicians across the country to bring the lifesaving advantages of early detection to their patients with just a blood draw.” He added that the ADLT status “reinforces the value that our Shield blood test for colorectal cancer screening brings to patients, offering a more pleasant and convenient option that can help increase the overall screening rate and improve outcomes.”
The ADLT designation also brings a Medicare reimbursement increase of $1,495 per test, up from $920, which analysts estimate could add roughly $10 million in additional revenue for Guardant Health. The partnership is therefore seen as a key driver of future revenue growth and a significant step toward scaling Shield’s commercial deployment.
Market reaction to the announcement has been positive, with analysts noting that the expanded access through Quest Diagnostics and the favorable Medicare reimbursement are likely to accelerate Shield’s adoption. Barclays analyst Luke Sergott highlighted that the timing of the ADLT status was ahead of expectations, while Andrew Brackmann reiterated an “Outperform” rating, citing the partnership as a catalyst for increased volumes.
Guardant Health is also advancing a Shield Multi‑Cancer Detection (MCD) test, which has received FDA Breakthrough Device designation, indicating a broader strategy to expand its blood‑based screening portfolio beyond colorectal cancer.
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