Caris Life Sciences, Inc.

Company focus

• Patient-centric TechBio company focused on precision medicine, with an initial emphasis on oncology.
• Develops and commercializes comprehensive molecular profiling and AI/ML-driven insights to support cancer care across the continuum: early detection, minimal residual disease (MRD) tracking, therapy selection, and treatment monitoring.
• Platform combines next-generation sequencing (NGS), AI/ML, and high-performance computing to generate clinically actionable information.

Core products and platforms

MI Profile Platform (tissue-based)

• Whole exome sequencing (WES) and whole transcriptome sequencing (WTS) on eligible tissue samples.
• Includes MI Cancer Seek (FDA PMA-approved companion diagnostic and tumor profiling device) and tissue-based IHC testing.
• Optional predictive molecular signatures: GPSai and FOLFIRSTai.

Caris Assure Platform (blood-based)

• WES/WTS in plasma with analysis of plasma and buffy coat (white blood cells) and CH subtraction to distinguish germline/age-related variants from tumor variants.
• Designed for therapy selection and expanding into MRD tracking and monitoring.
• Caris Assure MRD is in development; technical assessment for colorectal cancer submitted to MolDX.

Precision Whole Genome Platform (WGS)

• Blood- and tissue-based profiling using whole genome sequencing.
• Under development: Caris Detect (multi-cancer early detection, blood-based WGS) planned for launch in 2026; Caris WGS MRD; Caris ChromoSeq for blood cancers developed under an exclusive license with Washington University in St. Louis.

Caris Discover (drug target and therapeutic discovery)

• In silico target discovery using multi-modal clinico-genomic datasets.
• Wet-lab proteomics and validation (ADAPT Biotargeting, Proximity Labeling, Caris Surfacesome) to identify drug targets and neoantigens for personalized therapies.
• Collaborations and pipeline activity with partners including Genentech, Merck KGaA, and Xencor.

Caris Strategic Data

• Proprietary AI/ML-derived signatures and insights created from large multi-modal datasets.
• Data licensing of deidentified clinico-genomic data to external researchers and biopharma partners, using tokenization and HIPAA deidentification processes.

Caris Infrastructure

• In-house laboratory, R&D, and data infrastructure supporting end-to-end molecular profiling and analytics.

Signatures and decision-support

• GPSai: molecular disease classifier that predicts tumor origin and supports tissue-of-origin determination.
• FOLFIRSTai: predictor of efficacy for oxaliplatin-based chemotherapy regimens in metastatic colorectal cancer (mCRC).

Data assets, partnerships, and commercialization

• Clinico-genomic datasets: over 1,000,000 sequencing cases as of 12/31/2025; datasets include genomic data, clinical information, digitized slides, and remnant tissue.
• Caris Precision Oncology Alliance (POA): network of cancer centers and consortia with 99 members as of 12/31/2025, including more than 45 NCI-designated comprehensive cancer centers.
• CODEai: platform for exploring deidentified clinico-genomic datasets; cohort includes over 484,000 matched datasets with outcomes.
• Data licensing: deidentified datasets licensed to biopharma and researchers; partnerships include AbbVie and Moderna, among others.
• Biobank: large tissue biobank linked to multi-omic data for translational research and companion diagnostic development.

Customer base and market footprint

• More than 6,000 ordering physicians in the United States across major health systems, academic centers, and community settings.
• Customers include treating physicians, researchers, and biopharma companies.
• International distribution through distributors and direct contracts.
• In the U.S., MI Cancer Seek is FDA-approved as a companion diagnostic; MI Profile solutions are marketed as laboratory-developed tests (LDTs) with various payer and reimbursement arrangements.

Operations and facilities

• Laboratories and R&D (Arizona):
  • Solid tissue clinical laboratory in Phoenix (~66,000 sq ft) with ISO 15189, ISO 13485, CLIA, CAP, and state licensing.
  • Blood-based clinical laboratory in Phoenix (~35,500 sq ft) with ISO 15189, CLIA, and CAP.
  • R&D laboratory in Tempe (~59,000 sq ft) with ISO 13485.
• Throughput and technology:
  • High-throughput sequencing capabilities using NovaSeq 6000 and NovaSeq X systems.
• Global reach:
  • International sales via distributors and direct hospital system contracts.
  • UK-CA mark secured for Caris Assure and MI Cancer Seek; plans to pursue regulatory approvals in Japan and the European Union.

Regulatory and reimbursement landscape

• U.S. regulatory status:
  • MI Cancer Seek: FDA PMA approved as a companion diagnostic/tumor profiling device.
  • Other solutions are marketed as LDTs and are analytically validated under CLIA.
  • Caris Assure for therapy selection is marketed as an LDT with New York CLEP considerations; potential future PMA submissions are contemplated.
• Reimbursement:
  • Medicare coverage under the NGS NCD; MolDX coverage with LCDs for MRD (CRC, breast cancer, lung cancer) and NGS for myeloid malignancies.
  • CPT/PLA coding used for billing.
  • Caris Detect (MCED) expected to launch as a cash-pay offering at $3,500; reimbursement pathways will depend on regulatory and coverage decisions.
• International considerations:
  • EU IVDR transition has affected market access; regulatory approvals in other jurisdictions may be pursued as applicable.

Scale and footprint indicators

• Sequencing experience: over 1,000,000 cases sequenced as of 12/31/2025.
• POA membership: 99 members, including 45+ NCI-designated comprehensive cancer centers.
• CODEai cohort: over 484,000 matched datasets.
• Workforce: 1,846 employees as of 12/31/2025.
• U.S. market reach: more than 6,000 ordering physicians.
• Physical footprint: three primary Arizona facilities with approximately 66,000 sq ft (solid tissue), 35,500 sq ft (blood-based), and 59,000 sq ft (R&D).
• Licensing and collaborations: multiple licenses (e.g., WashU for ChromoSeq) and strategic biopharma partnerships for data-driven discovery and development.

Summary

Caris Life Sciences operates an end-to-end precision oncology platform that combines comprehensive molecular profiling (tissue and blood), AI/ML analytics, large-scale datasets, and a collaborative network of clinical and industry partners. The company commercializes laboratory-developed tests and FDA-approved companion diagnostics while pursuing broader regulatory approvals, MRD and MCED products, and data licensing opportunities to support clinical care and drug discovery.