Life Sciences Sequencing

Contact us

Overview

Comprehensive solutions for every stage of clinical development
Tempus leverages best-in-class laboratories to provide a variety of next-generation sequencing (NGS) tests and targeted arrays to support testing needs from discovery through to commercialization.

Strategic support for multiple stakeholders and projects

  • Retrospective studies
    Whole exome sequencing of bio-banked samples to identify molecular drivers in an early-phase clinical trial

  • Prospective clinical trials support
    Sequencing to support patient eligibility screening and molecular characterization of patients enrolled across later phase trial under a significant risk IDE

  • Companion diagnostic development
    Analytical and clinical validation of multiple biomarkers under a NGS assay for pursuit of a companion diagnostic partnership

  • Sponsored testing
    Testing specific cohorts of patients to identify appropriate patients for targeted therapies in rare patient populations

  • Investigator-initiated trials
    Centralized sequencing, bioinformatics and common data standards for all of a pharmaceutical partner’s IITs (1,000+ patients enrolled in 10+ separate investigator-initiated trials)

Read our case study with A2 Biotherapeutics→
Gantt chart illustrating project phases from discovery to post-approval for Partner and Tempus.Timeline showing research phases for Partner and Tempus, detailing specific development activities.

Proven partnership

250+
biopharma partnerships
95%
of the top 20 pharma companies partner with Tempus*
~65%
of all Academic Medical Centers in the US are connected to Tempus

*Based on publicly available 2024 segment revenue

Global solutions

With a presence in over 50 countries, Tempus provides the scale, speed, and local expertise to accelerate your global clinical development program from trial enrollment to launch.

The Americas

  • 7,000+ institutions and 7,500+ oncologists
  • Multiple FDA authorizations, including xT CDx1 and xR IVD2
  • ~1 million tests annually

European Union

  • 10 CE-marked assays with IVDR submissions in progress
  • Sales and distributor network in the EU5, Scandinavia, and other key markets
  • Local tech transfer partnerships for in-country testing

Asia-Pacific

  • Local market access and sequencing in Japan via SB TEMPUS Corp
  • Sequencing experience in 15+ Asian markets
  • Forthcoming local partnership and testing capabilities in China

Our assays

Tissue-based assays

Tempus xT CDx¹

(FDA authorized)

 

Description
648 gene panel, tumor/normal matched for solid tumors, and two companion diagnostic (CDx) claims for colorectal cancer (CRC) patients

 

Depth of sequencing

  • 500x median coverage of tumor samples
  • 95% of exons at >150x coverage
  • ≥98% of exons at ≥100x coverage

 

Accepted sample types
FFPE tumor tissue specimens, with DNA isolated from matched normal blood or saliva specimens

 

Alterations identified
SNVs, MNVs, insertions/deletions, MSI

 

Tumor type
Solid malignant neoplasms

Learn more about xT CDx→

Tempus xR IVD²

(FDA authorized)

 

Description
xR IVD is an NGS-based in vitro diagnostic test for the detection of BRAF and RET rearrangements in FFPE tumor tissue specimens from patients with solid malignant neoplasms.

 

Depth of sequencing
6 million unique deduplicated reads

 

Accepted sample types
FFPE blocks or unstained slides from previously diagnosed cancer patients with solid malignant neoplasms

 

Alterations identified
BRAF and RET rearrangements

 

Tumor type
Solid malignant neoplasms

Learn more about xR IVD→

Tempus xT

Description
648 gene panel for heme and solid tumors.

 

Depth of sequencing
500x depth of coverage for tumor specimens and 150x for normal specimens

 

Accepted sample types
FFPE tumor sample with matched normal blood or saliva (solid tumors); blood or bone marrow (circulating hematologic malignancies)

 

Alterations identified
SNVs, insertions/deletions, CNVs, fusions for select genes, MSI, TMB

 

Sensitivity
Chicago lab, solid tumor performance: 98.2% for SNVs, 91.1% for indels, 91.4% for copy number alterations, 90.5% for MSI, 90.9% for rearrangements

 

Tumor type
Heme and solid

View the xT validation summary→

Tempus xR

Description
Whole transcriptome RNA seq panel for solid tumors and hematologic malignancies.

 

Depth of sequencing
50 million reads

 

Accepted sample types
FFPE slides, blocks, frozen samples, extracted RNA (RUO), peripheral blood, bone marrow

 

Alterations identified
Rearrangements, fusions, altered splicing for MET Exon 14 and EGFRvIII

 

Sensitivity
97% for rearrangements/ fusions, 100% for altered splicing (MET Exon 14), 95.5% for altered splicing (EGFRvIII)

 

Tumor type
Heme and solid

Learn more about xR→

Tempus xE

Description
Whole exome, tumor/normal matched and whole transcriptome RNA-seq. Heme and solid tumors.

 

Depth of sequencing

  • DNA: 300x (648 genes), 250x for rest
  • RNA: ~50 million reads

 

Accepted sample types
FFPE tissue samples, matched to a normal blood or saliva sample

 

Alterations identified

  • DNA: SNVs, insertions/deletions, CNVs, TMB, MSI
  • RNA: Fusions, expression, altered splicing

 

Tumor type
Heme and solid

View the xE validation summary→

Liquid biopsy and MRD

Tempus xF+

Description
A comprehensive 523-gene liquid biopsy assay, including a 114-gene enhanced region.

 

Depth of sequencing
DNA sequencing is performed to >5,000x and >1,500x unique coverage for enhanced and additional regions, respectively.

 

Accepted sample types
Peripheral blood

 

Alterations identified

  • Detects SNVs, indels, CNGs, fusions, MSI-H, bTMB, and HLA Class I Genotyping
  • Identifies variants potentially associated with clonal hematopoiesis (CH)
  • Measures changes in ctDNA tumor fraction to determine early response to immunotherapy for patients with advanced cancers when used longitudinally

 

Sensitivity
97.9% for SNVs (≥ 0.2% VAF), 96.8% for indels (≥ 0.20% VAF), >99.9% for CNGs, 98.3% for rearrangements

 

Turnaround time
As low as ~7 days depending on project

Learn more about xF+→

Tempus xM MRD

Description
A tumor-naïve MRD assay that leverages dual methylation- and variant-based workflows to detect ctDNA and call MRD+/-.

 

Accepted sample types
Peripheral blood

 

Alterations identified
ctDNA, reported as MRD+/-

 

Tumor type
Colorectal cancer, early stage (II and III)

Learn more about xM MRD→

Tempus xM (NeXT Personal Dx®)

Test by Personalis

 

Description
A tumor-informed MRD assay that utilizes whole genome sequencing to identify up to 1800 somatic variants.

 

Accepted sample types
One blood draw

 

Alterations identified
ctDNA, detected at low levels to monitor residual disease and recurrence

 

Sensitivity
Ultra sensitive whole genome assay

Learn more about xM (NeXT Personal Dx®)→

Hematologic malignancies

Tempus xH

Description
A whole genome sequencing assay for hematologic malignancies that detects a comprehensive range of alterations, including complex structural variants.

 

Depth of sequencing
Targeting 80X mean autosomal coverage.

 

Accepted sample types
Blood or bone marrow (BM)

 

Alterations identified
SNVs, Indels, copy number alterations (CNAs ≥5 Mb), and structural variants (SVs)

 

Sensitivity
Demonstrated high positive percent agreement (PPA) when compared to orthogonal methods: 97.29% for SNVs/Indels, 92.86% for SVs, and 93.43% for CNAs.

 

Tumor type
Hematologic malignancies

Learn more about xH→

Tempus xH+

Powered by GenoPredicta™

 

Description
An ultrasensitive whole-genome sequencing (WGS) assay for comprehensive genomic characterization and Measurable Residual Disease (MRD) monitoring in hematologic malignancies.

 

Depth of sequencing
Targeted depth of 60x coverage for the tumor cell population and 15x for the matched normal

 

Accepted sample types
Whole blood (from which circulating tumor cells are isolated) or bone marrow

 

Alterations identified
Any variant type detectable by short read sequencing

 

Tumor type
Hematologic malignancies

Download the xH+ validation summary→

Hereditary cancer testing

CancerNext®

Description
40-gene guidelines-based germline panel that includes genes associated with hereditary breast, ovarian, pancreatic, prostate, colorectal, endometrial, gastric, small bowel, urothelial, and renal cancers.

 

Depth of sequencing
DNA: ~500x coverage

 

Accepted sample types
Peripheral blood (EDTA tube for DNA testing, PAXgene® blood tube for RNA analysis), saliva (Oragene®), or skin punch biopsy (cultured fibroblasts)

 

Alterations identified
DNA: SNVs, insertions/deletions, CNVs, fusions

 

Turnaround time
~5-14 days after specimen receipt

Learn more about hereditary cancer testing→

CancerNext-Expanded®

Description
77-gene germline panel that includes genes associated with hereditary breast, ovarian, pancreatic, prostate, colorectal, endometrial, gastric, small bowel, urothelial, renal, plus an array of additional cancers.

 

Depth of sequencing
DNA: ~500x coverage

 

Accepted sample types
Peripheral blood (EDTA tube for DNA testing, PAXgene® blood tube for RNA analysis), saliva (Oragene®), or skin punch biopsy (cultured fibroblasts)

 

Alterations identified
DNA: SNVs, insertions/deletions, CNVs, fusions

 

Turnaround time
~5-14 days after specimen receipt

Learn more about hereditary cancer testing→

Immunotherapy platform

Tempus IO™ is a comprehensive immunotherapy platform that provides actionable and cutting-edge services for life sciences partners advancing IO therapies, including antibody-drug conjugates (ADCs), TCR therapies, and immune checkpoint inhibitors (ICIs).

  • Comprehensive real-world data (RWD)
    ~99% of whole transcriptome profiles contain at least one IO biomarker

  • Robust suite of IO biomarkers
    10+ IO biomarkers available through Tempus sequencing

  • Advanced analytical tech
    Leverage AI- and ML-based analytical tools to unlock actionable insights

  • Immune Profile Score (IPS)
    First-of-its-kind biomarker utilizing DNA and RNA to prognosticate ICI response

Learn more about Tempus IO→

Our labs

Powering clinical development with data and technology

 

We operate CAP-accredited, CLIA-certified robotic sequencing labs in Chicago, Atlanta, and Raleigh with automated bioinformatics and variant classification reporting. Sequencing is typically completed within a median of 8 days after receiving samples.

Tempus Genomics document outlining sequencing services and state-of-the-art lab equipment.

Download our lab overview

References

  1. xT CDx is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device intended for use in the detection of substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insertion and deletion alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status, using DNA isolated from Formalin-Fixed Paraffin Embedded (FFPE) tumor tissue specimens, and DNA isolated from matched normal blood or saliva specimens, from previously diagnosed cancer patients with solid malignant neoplasms. The test is intended as a companion diagnostic (CDx) to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table in accordance with the approved therapeutic product labeling. Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product. xT CDx is a single-site assay performed at Tempus AI, Inc., Chicago, IL.For the complete xT CDx label, including companion diagnostic indications and important risk information, please visit tempus.com/xt-cdx-label/.
  2. The Tempus xR IVD assay is a qualitative next generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of rearrangements in two genes using RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens from patients with solid malignant neoplasms. Information provided by xR IVD is intended to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Results from xR IVD are not intended to be prescriptive or conclusive for labeled use of any specific therapeutic product. For the complete xR IVD label, including intended use, limitations, and important risk information, please visit tempus.com/xr-ivd-label/.
  3. Must be bundled with Tempus products or services.

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.