Guardant Health Receives ADLT Status from CMS for FDA-Approved Guardant360 CDx Test

Guardant Health, Inc. (Nasdaq: GH) announced that the Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT) status for the Guardant360 CDx test. The Guardant360 CDx test is the first FDA-approved liquid biopsy for comprehensive tumor mutation profiling across all solid cancers.

Under the Protecting Access to Medicare Act of 2014 (PAMA), CMS determination confirms that the Guardant360 CDx test meets the criteria for ADLT status, which is reserved for innovative products that provide novel clinical information that cannot be obtained by any other method, and for FDA-approved tests. Obtaining ADLT status initiates a specific, market-based approach to pricing the test for Medicare patients. During the nine-month period beginning April 1, 2021 and ending December 31, 2021, 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 January 1, 2022. During this nine-month period, the Guardant360 CDx test will be reimbursed at a rate of $5,000 for all Medicare patients.

“Obtaining ADLT status for our Guardant360 CDx test is an important milestone that not only demonstrates the value that our FDA-approved liquid biopsy test brings to patients with advanced cancer, but also paves the way for broader payer coverage,” said Helmy Eltoukhy, Guardant Health CEO. “We believe this milestone is a critical step to ensuring that all patients have access to our Guardant360 CDx test, so that their treatment is informed by comprehensive genomic profiling in-line with today’s medical guidelines.”

Each year, more than 600,000 people die from cancer in the United States,¹ many of whom may have benefitted from comprehensive genomic profiling (CGP) to guide a more personalized treatment plan based on a growing list of effective CGP-informed targeted therapies. Clinical studies show that patients receiving targeted therapies have improved progression-free survival and higher overall response rates relative to chemotherapy or immunotherapy.^2-8 Guardant360 CDx offers patients and clinicians a simple, faster blood test to help inform personalized treatment options.