Caris Life Sciences Wins MolDX Coverage for ChromoSeq Myeloid Cancer Test
The whole-genome sequencing assay for myeloid malignancies cleared a CMS reimbursement review, clearing a path to broader patient access.
Caris Life Sciences has received MolDX approval for Caris ChromoSeq, its whole-genome sequencing assay for myeloid malignancies, the company said on May 4.
“Our goal is to replace fragmented diagnostic workflows with a single, comprehensive assay that delivers clear, actionable insights to clinicians when time and accuracy matter most,” Matthew Oberley, Senior VP and Chief Clinical Officer at Caris, said in a statement.
The MolDX program, administered by Palmetto GBA on behalf of the Centers for Medicare & Medicaid Services (CMS), evaluates molecular diagnostic tests for clinical validity and utility to inform coverage and reimbursement decisions.
Caris ChromoSeq is an ultra-deep WGS-based assay designed for the clinical genomic evaluation of acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN) and other suspected myeloid malignancies. The assay sequences at up to eight times the depth of a standard deep WGS run, enabling detection of single nucleotide variants, insertions and deletions, copy number alterations, structural variants and gene fusions.