Tempus xF/xF+ liquid biopsy

Overview

Tempus xF is a 105 gene liquid biopsy circulating tumor DNA (ctDNA) seq panel that detects oncogenic drivers and resistance mutations, and identifies single nucleotide variants (SNVs), insertions and deletions (INDELs), copy number gains (CNGs) and gene rearrangements, all of which help inform precision medicine decisions.

 

Tempus xF+ is a 523 gene liquid biopsy panel, covering SNVs, INDELs, CNGs and gene rearrangements. Additionally, xF+ identifies variants that are potentially associated with clonal hematopoiesis of indeterminate potential (CH).

Key Features

Complementary testing with tissue and liquid
Data suggests that non-overlapping actionable gene alterations and resistance mechanisms may be detected using complementary tissue and liquid biopsy testing approaches.1,2,3 9% of patients with actionable variants in a metastatic pan-cancer analysis had unique actionable alterations found in liquid biopsy that were not detected in solid tumor alone.4

Monitor resistance
xF / xF+ can monitor common resistance mechanisms arising from frontline targeted therapies in several cancer types, including lung, breast, ovarian, and colorectal cancers, including but not limited to:

  • Lung cancer: EGFR & ALK resistance mutations5,6

  • Breast cancer: ESR1 mutations7

  • Ovarian and breast cancer: BRCA1/2 reversion mutations8

  • Colorectal cancer: Anti-EGFR resistance alterations9

Turnaround time
xF results are typically expected within 7 days of specimen retrieval.
xF+ results are typically expected within 7-9 days of specimen retrieval.

How to order

Ordering flexibility

 

Tempus offers a variety of options to customize molecular profiling for patients.

  • xF/xF+ may be ordered as a standalone test or in combination with xT CDx†

  • Longitudinal testing using xF / xF+ Liquid Biopsy

  • Automatic conversion option from xT CDx to xF/xF+ in the event of insufficient tumor tissue

  • Streamlined ordering process through Tempus Hub, paper requisition, or directly from your EHR

Access Tempus Hub ↗︎
Two modern smartphones displaying minimalist app interfaces on a clean white background.Two modern smartphones displaying minimalist app interfaces on a clean white background.

Financial assistance

We help provide access to our tests for all patients in financial need

 

Approval of the financial assistance application is based on your household income and takes into account all life circumstances. Once a financial assistance application is submitted either online or over the phone, you will receive a decision at the time of submission.

Apply for financial assistance online at access.tempus.com ↗︎

  • If approved, you will know immediately about the maximum out of pocket cost of your testing.

  • Please contact billing@tempus.com if you are concerned about out-of-pocket costs and would like to discuss your options.

All U.S.-based patients are eligible to apply for financial assistance regardless of insurance status. For international patients, we offer a self-pay option. If you have any questions, please email patients@tempus.com. Authorization for Medical Records: Through access.tempus.com, applicants are directed to our Notice and Authorization for Medical Records authorization form. This optional form allows us to request outcomes and other medical records from your health care providers. Please see the form for more information.

Test design

xF Performance Specifications

 

CHICAGO LAB

 

Variant ClassVAFSensitivitySpecificityLOD
Single Nucleotide Variants (SNVs)
≥0.25%
98.5%
>99.9%
0.25%
0.10%
66.7%
Insertions and Deletions (INDELs)
≥0.5%
98.5%
>99.9%
0.50%
0.25%
75.0%
Copy Number Gains (CNGs)
≥0.5%
>99.9%
96.2%
0.50%
0.50%
>99.9%
Rearrangements
≥1%
94.40%
>99.9%
1%
0.50%
75.00%
Microsatellite Instability High (MSI-H) Status
N/A
31.30%
>99.9%
N/A
Blood Tumor Mutational Burden (bTMB)
N/A
39.00%
95.30%
N/A

DURHAM LAB

 

Variant ClassVAFSensitivitySpecificityLimit of Detection
Single Nucleotide Variants (SNVs)
≥0.25%
99.6%
>99.9%
0.25%
0.10%
75.6%
Insertions and Deletions (INDELs)
≥0.5%
99.5%
>99.9%
0.50%
0.25%
91.1%
Copy Number Gains (CNGs)
≥2.5%
>99.9%
>99.9%
2.50%
1%
66.70%
Rearrangements
≥1%
>99.9%
99.20%
1%
0.50%
98.20%
Microsatellite Instability High (MSI-H) Status
N/A
85.70%
>99.9%
N/A
bTMB will only be reported for samples being run in the Tempus Chicago, Illinois laboratory.

xF+ Performance Specifications

 

CHICAGO LAB

 

Variant ClassVAFSensitivitySpecificityLOD
SNVs (Enhanced)
≥0.2%
98.3%
>99.9%
0.2%
SNVs (Non Enhanced)
≥1%
>99.9%
>99.9%
1%
INDELs (Enhanced)
≥0.25%
95.5%
>99.9%
0.25%
INDELs (Non Enhanced)
≥2%
87.5%
>99.9%
2%
CNGs
≥1%
>99.9%
93.0%
1%
Rearrangements
≥1%
96.8%
>99.9%
1%
MSI-H Status
-
90.0%
>99.9%
-
bTMB
-
63.6%
98.3%
-

Resources

White paper sheet with a grey clip attached at the top.Requisition Form
Scientific document displaying research findings, methods, and a table with genomic data.

xF Validation

White paper sheet with a grey clip attached at the top.Requisition Form
Screenshot displaying 'FIBPLUS APL: Liquid Biopsy Tests' API documentation with text and partial table.

xF+ Validation

Three white rectangles stacked vertically with soft grey shadows, forming layers.Specimen Guideline
A clinic guide document showing a table for ordering Tempus genetic tests with specimen details.

Clinical Kit Guide

Three white rectangles stacked vertically with soft grey shadows, forming layers.Specimen Guideline
Tempus document titled "Specimen Guidelines for Providers" for medical professionals.

Specimen Guidelines

White speech bubble icon with a diagonal fold, symbolizing communication or messages.Certification
Digital interface showing the Tempus Sequencing Laboratories web page with test information.

Lab Overview

Learn more

Clinical Trials →
Companion Diagnostics →

References

  1. Chae YK, Davis AA, Carneiro BA, et al. Concordance between genomic alterations assessed by next-generation sequencing in tumor tissue or circulating cell-free DNA. Oncotarget. 2016;7(40):65364-65373.
  2. Aggarwal C, Thompson JC, Black TA, et al. Clinical implications of plasma-based genotyping with the delivery of personalized therapy in metastatic non-small cell lung cancer. JAMA Oncol. 2019;5(2):173-180.
  3. Parikh AR, Leshchiner I, Elagina L, et al. Liquid versus tissue biopsy for detecting acquired resistance and tumor heterogeneity in gastrointestinal cancers. Nat Med. 2019;25(9):1415-1421.
  4. Based on a retrospective study involving a cohort of randomly selected patients with breast, colorectal, lung, and prostate cancer. Iams, WT, MacKay M, Ben-Shachar R, et al. Concurrent tissue and circulating tumor DNA molecular profiling to detect guideline-based targeted mutations in a multicancer cohort. JAMA Netw Open. 2024;7(1):e2351700. Clinically actionable variants were identified using indication-matched recommendations from NCCN guidelines
  5. Jenkins S, Yang JCH, Ramalingam SS, et al. Plasma ctDNA analysis for detection of the EGFR T790M mutation in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2017;12(7):1061-1070.
  6. Horn L, Whisenant JG, Wakelee H, et al. Monitoring therapeutic response and resistance: analysis of circulating tumor DNA in patients With ALK+ lung cancer. J Thorac Oncol. 2019 Nov;14(11):1901-1911.
  7. Bidard FC, Hardy-Bessard AC, Dalenc F, et al. Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising ESR1 mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomized, open-label, multicentre, phase 3 trial. Lancet Oncol. 2022;23(11):1367-1377.
  8. Lin KK, Harrell MI, Oza AM, et al. BRCA reversion mutations in circulating tumor DNA predict primary and acquired resistance to the PARP inhibitor rucaparib in high-grade ovarian carcinoma. Cancer Discov. 2019 Feb;9(2):210-219.
  9. Sartore-Bianchi A, Pietrantonio F, Lonardi S, et al. Circulating tumor DNA to guide rechallenge with panitumumab in metastatic colorectal cancer: the phase 2 CHRONOS trial. Nat Med. 2022;28(8):1612-1618.

 

† 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 Labs, Inc., Chicago, IL. For the complete xT CDx label, including companion diagnostic indications and important risk information, please visit tempus.com/xt-cdx-label/

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