Companion Diagnostics

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Overview

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

Multimodal datasets

 

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

8.5M+
de-identified research records
1.5M+
records with matched clinical data linked with genomic information
~350K
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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Commercialization across the 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.

7.5K+
oncologists rely on Tempus as their precision medicine partner
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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

Tempus biopharma partnerships

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

 

Our Partners

95%
of the top 20 pharma oncology companies
250+
biopharma partnerships
based on publicly available 2022 oncology segment revenue

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)
FDA-cleared in September 2025

 

xF+ (liquid biopsy)
Building new version of assay now under design controls

Our support

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

  • UO 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.

  • Population expansion

Multi-omics

  • Biomarker discovery

Sequencing

  • Biomarker discovery

  • Establish cut-offs for copy number variations, gene expression, etc.

  • Retroactive analysis of banked samples

  • Post-approval sponsored testing

CDx

  • IUO assay development

  • Sample acquisition and sequencing for analytical validation

  • Regulatory guidance and submissions

  • Pre-commercial planning

  • Post-approval sponsored testing

Trials

  • Trial site activation

  • Eligible patient identification and enrollment

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.

Featured resources

View more
Simple white graphic of a single sheet of paper or document, slightly angled.Article
Document outlining the TIME Network's impact on phase 1 oncology trial patient enrollment.

Accelerating a phase 1 oncology trial: The TIME Network's impact on patient enrollment

Discover how the Tempus TIME Trial Network empowered Pathos AI to launch a Phase 1 study more efficiently, helping them to reach critical milestones faster.

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Web page displaying title "Beyond the blueprint: RNA's role in ADC strategy" by Tempus.

Beyond the blueprint: A scientific deep dive on RNA’s role in ADC strategy

Joshua Bell, PhD, Life Sciences Divisional Vice President, explains why whole-transcriptome data is an important layer for understanding tumor biology and supporting research into the next generation of ADCs.

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Document titled 'Q&A: Designing a modern CDx strategy for ADCs' from Tempus.

Q&A: Designing a modern CDx strategy for ADCs

Tempus experts discuss the essential pillars of a modern CDx strategy, from leveraging multimodal data to streamlined regulatory pathways.

Simple white graphic of a single sheet of paper or document, slightly angled.Article
A webpage displays a Q&A article about navigating tumor complexity for building confidence in new targets.

Q&A: Navigating tumor complexity to build confidence in new targets

Justin Guinney, PhD, SVP of Cancer Genomics at Tempus, discusses the Tempus Loop platform and explains how it uses multimodal data and patient-derived organoids to accelerate early-stage discovery and validate novel targets with greater confidence.

A white circle partially overlapping a solid white square against a dark background.Case Study
Document showing 'Indication selection and biomarker strategy' with a pie chart illustrating target prevalence.

Validating a novel target and informing trial design for a first-in-class therapeutic

Discover how a biopharma company used Tempus’ de-identified multimodal data to support validation of a novel target and inform trial design for a first-in-class therapeutic.

A white circle partially overlapping a solid white square against a dark background.Case Study
Tempus Life Sciences document detailing indication selection and trial design with a bar chart.

Guiding indication expansion with multimodal real-world data

Discover how a biopharma company used Tempus’ multimodal RWD to guide its indication expansion strategy, helping them to identify new opportunities, prioritize R&D, and inform future trial design.

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A Q&A article title about using Real-World Data (RWD) in translational research.

Q&A: Using RWD to bridge discovery and development in translational research

Katie Igartua, PhD, VP of Translational Research, discusses how Tempus leverages RWD, AI, and systems biology to accelerate drug discovery and development.

Simple white graphic of a single sheet of paper or document, slightly angled.Article
Document outlining the TIME Network's impact on phase 1 oncology trial patient enrollment.

Precision Medicine 2.0: The operating system for oncology R&D

This white paper addresses the persistent challenges in oncology R&D, demonstrating how precision medicine has evolved into a new paradigm built on systems-level understanding and AI-driven insights.

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Tempus article discussing how transcriptomics and AI accelerate oncology research and development.

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

Leaders from Tempus, Genialis, and UC San Diego discuss how transcriptomic data and AI are accelerating oncology R&D. Explore emerging applications, from AI-driven algorithms to platforms like Tempus Loop.

Learn how multimodal data can support CDx development

Download our CDx Content Guide ↗︎

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

This is AI-enabled precision medicine

This is the future of healthcare.