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COMPANION DIAGNOSTICS

From development to commercialization, Tempus provides a data-driven approach to CDx partnerships leveraging a broad-panel platform used by thousands of oncologists.

MULTIMODAL DATASETS 

Use Tempus’ multimodal data to help identify, select and refine biomarkers for your clinical trial.

  • ~7M

    de-identified research records

  • 1M+

    records with matched clinical data linked with genomic information

  • 250K+

    records with whole transcriptome profiles

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CLINICAL TRIAL ASSAYS

Tempus applies an established, design-controlled, and validated platform approach with the goal of reducing development time and complexity for companion diagnostic approval.

Learn more about our suite of NGS assays
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IMMEDIATE COMMERCIALIZATION ACROSS TEMPUS NETWORK

Leverage Tempus’ network to help identify potentially eligible patients for clinical trial enrollment and introduce your therapy and companion diagnostic to market following FDA submission and approval.

  • 6.5K+

    oncologists rely on Tempus as their precision medicine partner

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Tempus Biopharma Partnerships

Top pharmaceutical and biotech companies trust Tempus to inform therapy development.

OUR PARTNERS

  • 90%

    of the top 20 pharma oncology companies*

    *based on publicly available 2020 oncology segment revenue

  • 200+

    biopharma partnerships

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OUR APPROACH TO CDx DEVELOPMENT

With extensive in-house regulatory expertise, Tempus’ approach to CDx development and approval is strategically designed to save time, reduce complexity and improve the probability of success. Tempus offers a wide range of NGS tests to support pharma, including DNA and RNA tissue-based assays to support IDE studies.

  • xT CDx (DNA) FDA approved in April 2023
  • xR IVD (RNA) Potential for regulatory submissions with updated version of assay
  • xF+ (Liquid biopsy) Building new version of assay now under design controls

Tempus can support CDx projects from early-stage discovery through to commercialization.

  • ALL SERVICES
    • Biomarker discovery
    • Establish cut-offs for copy number variations, gene expression, etc.
    • Retroactive analysis of banked samples
    • IUO assay development
    • Trial site activation
    • Eligible patient identification and enrollment
    • Sample acquisition and sequencing for analytical validation
    • Regulatory guidance and submissions
    • Pre-commercial planning
    • Post-approval sponsored testing
    • Population expansion
  • DATA
    • Biomarker discovery
    • Establish cut-offs for copy number variations, gene expression, etc.
    • Retroactive analysis of banked samples
    • IUO assay development
    • Trial site activation
    • Eligible patient identification and enrollment
    • Sample acquisition and sequencing for analytical validation
    • Regulatory guidance and submissions
    • Pre-commercial planning
    • Post-approval sponsored testing
    • Population expansion
  • MULTI-OMICS
    • Biomarker discovery
    • Establish cut-offs for copy number variations, gene expression, etc.
    • Retroactive analysis of banked samples
    • IUO assay development
    • Trial site activation
    • Eligible patient identification and enrollment
    • Sample acquisition and sequencing for analytical validation
    • Regulatory guidance and submissions
    • Pre-commercial planning
    • Post-approval sponsored testing
    • Population expansion
  • SEQUENCING
    • Biomarker discovery
    • Establish cut-offs for copy number variations, gene expression, etc.
    • Retroactive analysis of banked samples
    • IUO assay development
    • Trial site activation
    • Eligible patient identification and enrollment
    • Sample acquisition and sequencing for analytical validation
    • Regulatory guidance and submissions
    • Pre-commercial planning
    • Post-approval sponsored testing
    • Population expansion
  • CDx
    • Biomarker discovery
    • Establish cut-offs for copy number variations, gene expression, etc.
    • Retroactive analysis of banked samples
    • IUO assay development
    • Trial site activation
    • Eligible patient identification and enrollment
    • Sample acquisition and sequencing for analytical validation
    • Regulatory guidance and submissions
    • Pre-commercial planning
    • Post-approval sponsored testing
    • Population expansion
  • TRIALS
    • Biomarker discovery
    • Establish cut-offs for copy number variations, gene expression, etc.
    • Retroactive analysis of banked samples
    • IUO assay development
    • Trial site activation
    • Eligible patient identification and enrollment
    • Sample acquisition and sequencing for analytical validation
    • Regulatory guidance and submissions
    • Pre-commercial planning
    • Post-approval sponsored testing
    • Population expansion
  • Biomarker discovery
  • Establish cut-offs for copy number variations, gene expression, etc.
  • Retroactive analysis of banked samples
  • IUO assay development
  • Trial site activation
  • Eligible patient identification and enrollment
  • Sample acquisition and sequencing for analytical validation
  • Regulatory guidance and submissions
  • Pre-commercial planning
  • Post-approval sponsored testing
  • Population expansion
  • Biomarker discovery
  • Establish cut-offs for copy number variations, gene expression, etc.
  • Retroactive analysis of banked samples
  • IUO assay development
  • Trial site activation
  • Eligible patient identification and enrollment
  • Sample acquisition and sequencing for analytical validation
  • Regulatory guidance and submissions
  • Pre-commercial planning
  • Post-approval sponsored testing
  • Population expansion
  • Biomarker discovery
  • Establish cut-offs for copy number variations, gene expression, etc.
  • Retroactive analysis of banked samples
  • IUO assay development
  • Trial site activation
  • Eligible patient identification and enrollment
  • Sample acquisition and sequencing for analytical validation
  • Regulatory guidance and submissions
  • Pre-commercial planning
  • Post-approval sponsored testing
  • Population expansion
  • Biomarker discovery
  • Establish cut-offs for copy number variations, gene expression, etc.
  • Retroactive analysis of banked samples
  • IUO assay development
  • Trial site activation
  • Eligible patient identification and enrollment
  • Sample acquisition and sequencing for analytical validation
  • Regulatory guidance and submissions
  • Pre-commercial planning
  • Post-approval sponsored testing
  • Population expansion
  • Biomarker discovery
  • Establish cut-offs for copy number variations, gene expression, etc.
  • Retroactive analysis of banked samples
  • IUO assay development
  • Trial site activation
  • Eligible patient identification and enrollment
  • Sample acquisition and sequencing for analytical validation
  • Regulatory guidance and submissions
  • Pre-commercial planning
  • Post-approval sponsored testing
  • Population expansion
  • Biomarker discovery
  • Establish cut-offs for copy number variations, gene expression, etc.
  • Retroactive analysis of banked samples
  • IUO assay development
  • Trial site activation
  • Eligible patient identification and enrollment
  • Sample acquisition and sequencing for analytical validation
  • Regulatory guidance and submissions
  • Pre-commercial planning
  • Post-approval sponsored testing
  • Population expansion

Support throughout every stage of drug development.

  • Discovery & Preclinical

    Tempus Explore

    Tempus bioinformatics experts help you answer your oncology research questions and meet your research objectives efficiently.

    Multi-omics

    Empowers pharma partners with access to bioinformatics experts to help answer research questions comprehensively and reach objectives efficiently.

  • PHASE I–III

    NGS & Multi-omics

    Leverage Tempus’ CAP-accredited, CLIA-certified robotic sequencing labs for NGS diagnostics, polymerase chain reaction (PCR), profiling, molecular genotyping, and other anatomic and molecular pathology testing solutions.

    TIME, Connect, Aware

    Tempus’ smart clinical trial matching tools save time and maximize the probability of technical success.

  • Regulatory Services

    Tempus’ regulatory team is closely involved with CDx projects to develop and execute robust regulatory strategies.

  • Post-Approval

    Sponsored Testing

    Address barriers to testing specific cohorts of patients to identify appropriate patients for targeted therapies.

Tempus Explore

Tempus bioinformatics experts help you answer your oncology research questions and meet your research objectives efficiently.

Multi-omics

Empowers pharma partners with access to bioinformatics experts to help answer research questions comprehensively and reach objectives efficiently.

NGS & Multi-omics

Leverage Tempus’ CAP-accredited, CLIA-certified robotic sequencing labs for NGS diagnostics, polymerase chain reaction (PCR), profiling, molecular genotyping, and other anatomic and molecular pathology testing solutions.

TIME, Connect, Aware

Tempus’ smart clinical trial matching tools save time and maximize the probability of technical success.

Tempus’ regulatory team is closely involved with CDx projects to develop and execute robust regulatory strategies.

Sponsored Testing

Address barriers to testing specific cohorts of patients to identify appropriate patients for targeted therapies.

The Tempus Difference

  • Save time

    Additional CDx claims can be added without building a new platform

  • Reduce complexity

    Reduces the need to work with multiple vendors across your pipeline

  • Improve probability of success

    Generates data to help identify subpopulations and develop more targeted therapies

Featured Resources

View more

CMS Awards Tempus With Advanced Diagnostic Laboratory Test (ADLT) Status for its xT CDx Test

Tempus AI, Inc. (NASDAQ: TEM), a leader in artificial intelligence and precision medicine, announced that the Centers for Medicare & Medicaid Services (CMS) has granted Advanced Diagnostic Laboratory Test (ADLT) status for Tempus’ next-generation sequencing assay.

Read press release

Learn how multimodal data can support CDx development.

Download our CDx Content Guide

Other Solutions for Life Sciences

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