Irving, Texas, USA, November 11th / PRNewswire / -- Caris Life Sciences ® ( Caris ) announced today that the first cohort of patients has been enrolled in a prospective, real-world observational study to evaluate Caris ChromoSeq ™. This is a whole-genome sequencing ( WGS ) test designed to provide comprehensive genomic characterization analysis for myeloid malignancies through a single integrated process. The first cohort of patients was enrolled in late September 2026, marking the beginning of the generation of prospective evidence for this test.

This study is an important milestone in Caris's efforts to simplify one of the most fragmented molecular testing paradigms in oncology. It is expected that approximately 300 adult patients suffering from acute myeloid leukemia ( AML ), myelodysplastic syndromes ( MDS ), and myeloproliferative neoplasms ( MPN ) will be enrolled through multiple institutions in the United States, with the study continuing until 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 typically requires coordination between multiple laboratories and platforms, leading to delays, administrative complexities, and challenges in integrating the dispersed test results into a single clinical interpretation.

Caris ChromoSeq Combining whole-genome and whole-transcriptome sequencing, it provides high-resolution genomic analysis in a single integrated report, with a turnaround time of about 7 days. This prospective study will evaluate the performance of this comprehensive approach in routine clinical practice and compare it with traditional testing methods in key indicators such as risk stratification, ease of use, and turnaround time.

Caris Life Sciences The president stated: "Oncology has already embraced comprehensive molecular profiling, but patients with myeloid malignancies are still often assessed through a fragmented testing process that requires multiple tests and various workflows. The development of Caris ChromoSeq is aimed at challenging this approach. This study is intended to generate the necessary real-world evidence to demonstrate how a single whole-genome sequencing process can provide a more comprehensive and efficient method of molecular characterization."

The scientific basis for whole-genome sequencing in myeloid malignancies has been established. Studies published in the New England Journal of Medicine indicate that whole-genome sequencing can support the diagnosis and risk stratification of patients with AML and MDS. However, despite these advancements, its adoption in routine clinical practice remains limited.

Caris ChromoSeq The research aims to answer the following key question: How does the workflow based on whole-genome sequencing perform in real-world clinical settings across different institutions and patient populations?

The study, titled "Observational Study Describing the Performance of Caris ChromoSeq Compared to Conventional Cytogenetics, FISH, and NGS in Patients with Hematological Malignancies Undergoing Caris ChromoSeq Testing" ( NCT07680868 ), was approved by the Institutional Review Board on April 23, 2026. The first cohort of patients began enrollment in late September 2026.

The initiation of patient enrollment follows closely after the approval of MolDX for Caris ChromoSeq, and also marks an important step forward for Caris in expanding the accessibility of whole-genome sequencing, while generating the prospective clinical evidence required to support broader adoption.

About Caris ChromoSeq

Caris ChromoSeq ™ is a whole-genome and whole-transcriptome sequencing test designed to provide comprehensive genomic characterization of myeloid malignancies, including acute myeloid leukemia, myelodysplastic syndromes, and myeloproliferative neoplasms. By integrating genomic analysis into a single workflow and report, Caris ChromoSeq aims to simplify the traditionally fragmented testing methods, while providing clinically relevant molecular information for diagnosis, risk stratification, and patient management.

About Caris Life Sciences

Caris Life Sciences ® ( Caris ) is a leading TechBio company that is actively developing and commercializing innovative solutions to drive healthcare transformation. Through comprehensive molecular profiling (whole-genome, exome, and transcriptome sequencing), advanced artificial intelligence, and machine learning, Caris has established large-scale, multi-modal clinical-genomic databases and computational capabilities for analyzing and further revealing the molecular complexity of diseases. This integration of next-generation sequencing, artificial intelligence, machine learning technologies, and high-performance computing provides a differentiated platform for developing a new generation of advanced precision medical diagnosis solutions, suitable for early detection, diagnosis, monitoring, treatment selection, and drug development.

The founding vision of Caris is to realize the potential of precision medicine to improve human health. The company's headquarters are located in Irvine, Texas, and it has offices in Phoenix, New York, Cambridge, Massachusetts, Tokyo, and Basel, Switzerland. Caris or its distribution partners provide services in the United States and other international markets.

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