Adaptive Biotechnologies Announces Clinical Lab Fee Schedule Rate of $2,007 for clonoSEQ® Test for Minimal Residual Disease Assessment is Effective as of January 1st, 2025

Core Insights - Adaptive Biotechnologies Corporation announced the new Medicare Clinical Laboratory Fee Schedule (CLFS) rate for its clonoSEQ test, set at $2,007 effective January 1, 2025, reflecting the final gapfill rate recommendation for the test [1][2] Group 1: Medicare and clonoSEQ Test Pricing - The CLFS, managed by the Centers for Medicare & Medicaid Services (CMS), establishes payment rates for lab tests covered by Medicare, with clonoSEQ undergoing a gapfill determination process due to its novel nature [2] - MolDX has updated clonoSEQ episode pricing to $8,029, aligning with the new CLFS rate across various indications including multiple myeloma and chronic lymphocytic leukemia [3] Group 2: Clinical Significance and Adoption - The finalization of the Medicare reimbursement rate for clonoSEQ is a significant milestone, emphasizing the test's value in patient care and its role in providing essential insights into disease status and therapy response [4] - clonoSEQ is recognized for its accurate and sensitive measurement of minimal residual disease (MRD) in lymphoid malignancies, with broad coverage by Medicare and commercial payers [4][6] Group 3: Technology and Applications - clonoSEQ is the first FDA-cleared in vitro diagnostic test for detecting MRD in patients with multiple myeloma and B-cell acute lymphoblastic leukemia, and is also available for diffuse large B-cell lymphoma as a laboratory-developed test [5] - The test utilizes Adaptive Biotechnologies' proprietary immune medicine platform to identify and quantify specific DNA sequences in malignant cells, aiding in monitoring MRD and predicting patient outcomes [6]