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]