Caris Life Sciences’ ChromoSeq receives MolDX approval

Caris Life Sciences (CAI) announced that Caris ChromoSeq has received MolDX approval, a milestone supporting broader clinical access to Caris’ comprehensive whole genome tumor profiling assay for myeloid malignancies. The Molecular Diagnostic Services, or MolDX, program, administered by Palmetto GBA on behalf of the Centers for Medicare & Medicaid Services or CMS, evaluates molecular diagnostic tests to determine whether they demonstrate clinical validity and utility to support coverage and reimbursement decisions. MolDX approval reflects a rigorous review of the test performance and medical usefulness. Caris ChromoSeq is the first and only ultra-deep whole genome sequencing, or WGS, assay for myeloid malignancies. Caris ChromoSeq is designed to support the comprehensive clinical genomic evaluation of acute myeloid leukemia or AML, myelodysplastic syndromes or MDS, myeloproliferative neoplasms or MPN, and other suspected myeloid malignancies. Caris ChromoSeq is designed to replace serial testing with one integrated approach. Results are consolidated into a single clinical report to support timely treatment decisions.