On November 11, 2026 Caris Life Sciences (Caris), a leading next-generation AI TechBio company, reported that the first patients have been enrolled in a prospective, real-world observational study evaluating Caris ChromoSeq, a Whole Genome Sequencing (WGS) assay designed to provide comprehensive genomic characterization of myeloid malignancies through a single integrated workflow. The first patients enrolled in late September 2026, marking the start of prospective evidence generation for the assay.

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The study represents a significant milestone in Caris’ effort to simplify one of the most fragmented molecular testing paradigms in oncology. Approximately 300 adult patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN) will be enrolled across multiple U.S. institutions through July 2027.

For decades, clinicians have relied on a combination of cytogenetics, fluorescence in situ hybridization (FISH) and targeted next-generation sequencing (NGS) to characterize myeloid malignancies. This multi-test approach often requires coordination across multiple laboratories and platforms, creating delays, administrative complexity, and the challenge of integrating separate test results into a single clinical interpretation.

Caris ChromoSeq leverages Whole Genome and Whole Transcriptome Sequencing to deliver high-resolution genomic profiling in a single integrated report with a turnaround time of approximately seven days. The prospective study will evaluate how this comprehensive approach performs in routine clinical practice compared with conventional testing methods across key measures including risk stratification, ease of use, and turnaround time.

"Oncology has embraced comprehensive molecular profiling, yet patients with myeloid malignancies are often still evaluated through a fragmented testing process that requires multiple assays and workflows," said David Spetzler, MS, PhD, MBA, President of Caris Life Sciences. "Caris ChromoSeq was developed to challenge that paradigm. This study is designed to generate the real-world evidence needed to demonstrate how a single Whole Genome Sequencing workflow can provide a more comprehensive and efficient approach to molecular characterization."

The scientific foundation for Whole Genome Sequencing in myeloid malignancies has already been established. Research published in The New England Journal of Medicine demonstrated that Whole Genome Sequencing can support diagnosis and risk stratification in patients with AML and MDS. However, despite these advances, adoption in routine clinical practice remains limited.

The Caris ChromoSeq study is intended to address the next critical question: how a Whole Genome Sequencing based workflow performs in real-world clinical settings across diverse institutions and patient populations.

The study, "An observational study to describe the performance of Caris ChromoSeq as compared to conventional cytogenetics, FISH, and NGS testing among patients receiving the Caris ChromoSeq assay for hematologic malignancies" (NCT07680868), received Institutional Review Board approval on April 23, 2026. The first patients began enrollment in late September 2026.

The start of patient enrollment follows MolDX approval of Caris ChromoSeq and marks another important milestone in Caris’ strategy to expand access to Whole Genome Sequencing while generating the prospective clinical evidence necessary to support broader adoption.

About Caris ChromoSeq
Caris ChromoSeq is a Whole Genome and Whole Transcriptome Sequencing assay designed for the comprehensive genomic characterization of myeloid malignancies, including acute myeloid leukemia, myelodysplastic syndrome and myeloproliferative neoplasms. By consolidating genomic analysis into a single integrated workflow and report, Caris ChromoSeq is designed to simplify traditionally fragmented testing approaches while delivering clinically relevant molecular insights for diagnosis, risk stratification and patient management.

(Press release, Caris Life Sciences, NOV 11, 2026, View Source [SID1234674616])