By Chris Wack
Guardant Health shares were 11% higher, at $39.90, after the company said the Centers for Medicare & Medicaid Services has approved Advanced Diagnostic Laboratory Test status for the company's Shield blood test for colorectal cancer screening.
The precision oncology company received Food and Drug Administration approval for Shield in July 2024 as the first blood test for primary CRC screening.
Guardant Health said the CMS determination confirms that the Shield test meets the criteria for ADLT status, which is reserved for innovative products that provide novel clinical information that can't be obtained by any other method, and for FDA-approved tests.
Medicare already covers the test. The Shield test will be reimbursed at the amount of $1,495 for Medicare patients during the initial nine-month ADLT period beginning April 1.
During the initial ADLT period, Guardant Health will collect, assess and submit private-payer payment rate data for the test, the median of which will be used by CMS to determine the Medicare pricing, beginning Jan. 1, 2026. This rate will be the payment amount for Shield from Jan. 1, 2026, to Dec. 31, 2027.
The Shield blood test is FDA approved for primary non-invasive screening for colorectal cancer in average-risk individuals age 45 and older.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
March 11, 2025 11:03 ET (15:03 GMT)
Copyright (c) 2025 Dow Jones & Company, Inc.
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