First patients enrolled in prospective, multi-institutional study evaluating whether a single Whole Genome Sequencing workflow can replace conventional cytogenetics, FISH and targeted NGS testing

IRVING, Texas, Nov. 11, 2026 /PRNewswire/ -- Caris Life Sciences^® (Caris), a leading next-generation AI TechBio company, today announced 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.

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.

About Caris Life Sciences 
Caris Life Sciences^® (Caris) is a leading TechBio company actively developing and commercializing innovative solutions to transform healthcare. Through comprehensive molecular profiling (Whole Genome, Whole Exome and Whole Transcriptome Sequencing), advanced AI and machine learning, Caris has created the large-scale, multimodal clinico-genomic database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of next-generation sequencing, AI and machine learning technologies and high-

performance computing provides a differentiated platform for developing the latest generation of advanced precision medicine diagnostic solutions for early detection, diagnosis, monitoring, therapy selection and drug development.

Caris was founded with a vision to realize the potential of precision medicine to improve the human condition. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S. and other international markets.

Forward-Looking Statements
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You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in these forward-looking statements are reasonable based on information currently available to us, we cannot guarantee that the future results, discoveries, levels of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. Forward-looking statements involve known and unknown risks and uncertainties, some of which are beyond our control. Risks and uncertainties that could cause our actual results to differ materially from those indicated or implied by the forward-looking statements in this press release include, among other things: continued development, performance and commercialization of Caris Detect; developments in the precision medicine industry; our future financial performance, results of operations or other operational results or metrics; development, analytical and clinical validation, timing and performance of future solutions by us and our competitors; commercial market acceptance for our solutions, including acceptance of preventive as well as diagnostic testing paradigms, and our ability to meet resulting demand; the rapidly evolving competitive environment in which we operate; third-party payer reimbursement and coverage decisions related to our solutions; the impact on our future volumes of the continued execution of our strategy to re-align and expand our sales organization; risks related to data management, storage, and processing capabilities and our ability to integrate and deploy artificial intelligence and advanced data analytics technologies; our ability to protect and enhance our intellectual property; regulatory requirements, decisions or approvals (including the timing and conditions thereof) related to our solutions, including our application for New York State Department of Health approval for Caris Assure; reliance on third-party suppliers; risks related to data security, patient privacy, and compliance with healthcare data protection regulations as well as potential cybersecurity threats to our data platforms; our compliance with laws and regulations; the outcome of government investigations and litigation; risks related to our indebtedness; and our ability to hire and retain key personnel as well as risks, uncertainties; and other factors described in the section titled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed on March 3, 2026, and in our other filings we make with the SEC from time to time. We undertake no obligation to update any forward-looking statements to reflect changes in events, circumstances or our beliefs after the date of this press release, except as required by law.

Caris Life Sciences Media:
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