Guardant Health’s Shield Colorectal Cancer Blood Test Garners CMS Advanced Diagnostic Status
NEW YORK – Guardant Health announced Tuesday that its Shield blood test for colorectal cancer screening has received Advanced Diagnostic Laboratory Test (ADLT) status from the US Centers for Medicare and Medicaid Services.
The test will be reimbursed at the price of $1,495 per test for Medicare patients during the initial nine-month ADLT period starting on April 1. During that period, Guardant will collect, assess, and submit payment rate data from private payors, and the median of those rates will be used by CMS to determine the Medicare pricing, beginning Jan. 1, 2026, Guardant said in a statement. That median rate will be the payment amount from Jan. 1, 2026, to Dec. 31, 2027.
The previous reimbursement rate for Shield was $920. Guardant said last month when reporting the firm’s 2024 financial results that the majority of the company’s revenue from Shield testing in 2024 came from the Medicare population.
To be eligible for ADLT status, a test must be either a sole-source US Food and Drug Administration-cleared assay or a sole-source Multianalyte Assay with Algorithmic Analyses. ADLTs must also be clinically unique and provide information that is not already provided by existing tests.
Shield received approval from the FDA in July for use as a colorectal cancer screening test in average-risk patients aged 45 or older.
“Obtaining 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,” Guardant Health co-CEO AmirAli Talasaz said in a statement. “We’ve already seen strong adoption by providers with Medicare-covered patient populations. This designation from CMS and a more favorable Medicare rate will help us bring the innovation of Shield to more patients coast to coast by accelerating our investments in building our commercial infrastructure.”
In a note to investors, Barclays analyst Luke Sergott said that ADLT status for Shield was widely expected, but “timing is ahead of expectations,” as many thought ADLT status would be confirmed in mid-2025. ADLT status will also drive an increase in average selling price for the test this year.
“Even though this will be a meaningful upside driver to [revenues], the key metric investors will focus on is volumes, which should also get a little help from the ADLT status,” he noted.
In late morning trading on the Nasdaq, Guardant’s stock was up more than 13 percent at $40.69 per share.