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.

  • 8M+

    de-identified research records

  • 1.5M+

    records with matched clinical data linked with genomic information

  • ~300K

    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

  • 95%

    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.

  • 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.

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

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    07/24/2025
    UPCOMING WEBINAR:

    Q&A: How Transcriptomics and AI Are Accelerating Oncology R&D

    In a recent webinar hosted by Tempus, industry leaders from healthcare and life sciences gathered to explore current and emerging applications of transcriptomic data in oncology.

    Read more
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    07/23/2025
    UPCOMING WEBINAR:

    Q&A: How Tempus applies AI for clinical research and patient care

    Tempus leaders Chris Scotto DiVetta, SVP & General Manager of AI Applications, and Jonathan Ozeran, VP of Generative AI, discuss how the Tempus platform leverages AI and machine learning to support standard of care practices, helping providers adhere to clinical guidelines and drive insights that help refine clinical trial strategy.

    Read more
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    06/09/2025
    UPCOMING WEBINAR:

    Bridging the translational gap: The role of organoids in oncology R&D

    This white paper explores the evolving role of organoids in oncology R&D, highlighting their potential as predictive preclinical models and their ability to reduce translational risk. Download for a comprehensive overview of the scientific landscape, key adoption barriers, emerging innovations, and how pharma companies leverage organoids to accelerate precision medicine.

    Read more
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    05/09/2025
    UPCOMING WEBINAR:

    Q&A: Integrating MRD and IO Monitoring with the Tempus portfolio: An oncologist’s perspective

    This Q&A article features a discussion between Dr. Allan Espinosa of Arizona Oncology and Dr. Ezra Cohen, Chief Medical Officer at Tempus, exploring the practical application of Tempus’ tumor-naive and tumor-informed MRD and IO treatment monitoring portfolio in clinical practice.

    Read more
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    05/01/2025
    UPCOMING WEBINAR:

    Q&A: Connecting real-world data and organoids through Tempus Loop

    Tim Hagerty, Ph.D, VP, Life Science Strategy at Tempus, discusses Tempus Loop, a platform aimed at enhancing target identification and validation by connecting real-world data with patient-derived organoids. He explains how this integrated approach overcomes limitations in traditional methods and its potential to accelerate preclinical development in oncology.

    Read more
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    04/02/2025
    UPCOMING WEBINAR:

    Development of a clinical algorithm to prognosticate response to immunotherapy

    Discover how Tempus developed and deployed the Immune Profile Score (IPS)—a powerful algorithm that provides prognostic insights into patient outcomes following treatment with immune checkpoint inhibitors (ICIs)—in ~18 months. This case study highlights the AI-driven methodology, real-world validation, and the impact of IPS in precision oncology.

    Read more
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    03/25/2025
    UPCOMING WEBINAR:

    AI & ML in action: Unlocking RWD with GenAI through Tempus Lens

    Discover how Tempus is equipping researchers with innovative AI solutions to fully leverage the potential of multimodal data. Gain insights from a panel of leaders across healthcare and life sciences as they discuss the impact of these advanced tools on delivering insights with speed.

    Watch replay
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    02/20/2025
    UPCOMING WEBINAR:

    Oncology innovation: How emerging biotechs lead through RWD & AI

    Ryan Fukushima, Chief Operating Officer at Tempus, discusses how cutting-edge tools are helping biotechs streamline clinical trials, optimize patient selection, and improve decision-making, even amidst challenging market conditions.

    Read more
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    02/13/2025
    UPCOMING WEBINAR:

    AI & ML in action: Real-time advances in precision medicine

    Explore the capabilities of the Tempus platform, where cutting-edge diagnostics meet actionable data insights to enhance precision medicine.

    Watch replay

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

Trusted by hundreds of biopharma to power drug development

EXPLORE LIFE SCIENCES SOLUTIONS

The information on this page is intended for life sciences companies and focuses on research and development applications.

Learn more about partnering with Tempus

This is the future of healthcare.