Caris Life Sciences announced that its Caris ChromoSeq assay has received MolDX approval, a key regulatory milestone that authorizes broader clinical use of the test for myeloid malignancies.
The approval was granted by the Centers for Medicare & Medicaid Services’ MolDX program, administered by Palmetto GBA, confirming that Caris ChromoSeq meets the required standards for clinical validity and utility. The certification enables Medicare and commercial payers to cover and reimburse the assay, opening a new revenue channel for the company.
Caris ChromoSeq is the world’s first ultra‑deep whole‑genome sequencing assay for myeloid cancers, sequencing at up to eight times the depth of typical deep WGS. It detects single‑nucleotide variants, insertions and deletions, copy‑number alterations, structural variants, and gene fusions, and integrates whole transcriptome sequencing. The comprehensive report replaces multiple fragmented diagnostic tests, potentially reducing turnaround time and simplifying the workflow for clinicians.
The approval expands access to a comprehensive genomic profile that can accelerate treatment decisions. Caris positions the assay as a market differentiator, potentially capturing a larger share of the myeloid oncology market, which is driven by demand for advanced profiling. The company’s AI‑driven platform and extensive clinico‑genomic database support the assay’s clinical utility and reinforce its competitive advantage.
Dr. Matthew Oberley, Senior Vice President and Chief Clinical Officer, said the approval “represents an important step in expanding access to highly informative genomic testing for patients with complex myeloid cancers. 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.”
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