Caris ChromoSeq received approval from the MolDX program, enabling Medicare coverage and reimbursement for its ultra-deep whole genome sequencing assay targeting myeloid malignancies. This regulatory endorsement follows a rigorous review of the assay’s clinical validity and utility.

The assay performs whole genome sequencing at up to eight times the depth of standard deep runs, allowing sensitive detection of single-nucleotide variants, insertions, deletions, copy number changes, structural variants and gene fusions in AML, MDS and MPN cases.

By replacing multiple separate tests with a single integrated assay, ChromoSeq consolidates results into one clinical report, reducing complexity and turnaround times for clinicians making critical treatment decisions in complex myeloid cancer cases.

Medicare reimbursement support is expected to broaden clinical access to comprehensive genomic profiling, potentially accelerating diagnosis and tailored treatment strategies for patients with acute myeloid leukemia and related disorders.