Caris Life Sciences Achieves Key Milestone with MolDX Approval for Caris ChromoSeq

Caris Life Sciences Achieves MolDX Approval for Caris ChromoSeq

On May 4, 2026, Caris Life Sciences, a trailblazer in precision medicine and advanced AI TechBio, announced a significant advancement in cancer diagnostic capabilities. The company’s Caris ChromoSeq™ has been granted MolDX approval, marking a pivotal moment for increased accessibility to comprehensive whole genome tumor profiling for myeloid malignancies.

The MolDX program, managed by Palmetto GBA for the Centers for Medicare & Medicaid Services (CMS), meticulously assesses molecular diagnostic tests to confirm their clinical validity and utility, aiding in coverage and reimbursement decisions. This endorsement is rooted in a comprehensive evaluation of the test’s performance and magnitude of medical application, which bolsters the accessibility of high-value molecular diagnostics to suitable patients.

The Significance of Caris ChromoSeq

Caris ChromoSeq stands out as the first and only ultra-deep whole genome sequencing (WGS) assay specifically tailored for myeloid malignancies. It offers an unprecedented sequencing depth, achieving results up to eight times deeper than conventional tests. This capability allows for sensitive identification and comprehensive detection of crucial genomic alterations, significantly enhancing patient care.

Dr. Matthew Oberley, Senior Vice President and Chief Clinical Officer at Caris, emphasized the milestone, stating, “Securing MolDX approval for Caris ChromoSeq represents an important step in expanding access to highly informative genomic testing for patients with complex myeloid cancers.” He highlighted that the aim is to streamline fragmented diagnostic processes into a unified, comprehensive assay, providing timely, actionable insights to healthcare professionals when accuracy is crucial.

Comprehensive Clinical Evaluation

Designed to facilitate a thorough clinical genomic evaluation of acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPN), Caris ChromoSeq leverages ultra-deep WGS to detect a wide array of mutations. These include single-nucleotide variants, structural variations, and gene fusions, which are pivotal for accurate diagnosis, risk assessment, and effective clinical decision-making.

In stark contrast to traditional diagnostic methods that often require multiple separate assays, Caris ChromoSeq seeks to replace prolonged testing with a singular, integrated approach. This not only simplifies the diagnostic pathway but also minimizes potential delays in patient treatment. All findings are compiled into a singular, straightforward clinical report designed to support prompt therapeutic decisions.

Implications for Clinicians and Patients

This significant achievement reaffirms the clinical performance of the Caris ChromoSeq assay, bolstering confidence among healthcare providers regarding its evidential foundation. For patients, this breakthrough represents a major step forward in accessing detailed genomic insights that can guide the management of complex genetic conditions associated with myeloid malignancies.

About Caris Life Sciences

Caris Life Sciences is at the forefront of pioneering precision medicine solutions. The company focuses on redefining healthcare through advanced molecular profiling technologies, including Whole Genome, Whole Exome, and Whole Transcriptome Sequencing. By utilizing sophisticated AI and machine learning tools, Caris has established a robust clinico-genomic database designed to navigate the intricacies of disease molecularity. The integration of cutting-edge sequencing techniques, AI analytics, and high-performance computational power sets Caris apart in the quest to develop next-generation precision medicine diagnostics.

Founded on the vision to harness the power of precision medicine, Caris is headquartered in Irving, Texas, with additional offices in Phoenix, New York, Cambridge, Tokyo, and Basel. The company is committed to providing its services globally, delivering innovative solutions to meet the evolving needs of patients and healthcare providers.

For inquiries, please contact:
Caris Life Sciences Corporate Communications
Email: [email protected]
Phone: 214.294.5606