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TEST:
Tempus xF Assay

Company:
Tempus
Type:
Laboratory Developed Test
Related tests:
Evidence

News

22d
Association of a ctDNA biomarker of treatment response with clinical outcomes in a real-world pan-cancer cohort treated with tyrosine kinase inhibitors (AACR 2024)
xF monitor can be used as a strategy to identify patients at a high risk of progression who could benefit from early switch or intensifying therapy. Results need to be prospectively validated in a larger cohort.
Clinical • Clinical data • Real-world evidence • IO biomarker • Pan tumor • Circulating tumor DNA • Real-world
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Tempus xF Assay • Tempus xF Monitor assay
22d
A circulating tumor fraction DNA biomarker response stratified by ESR1 mutation status correlates with overall survival in patients with HR+ HER2- metastatic breast cancer (AACR 2024)
Patients with ESR1m acquired on AI may retain treatment response if switched to selective estrogen receptor degraders (SERDs) like fulvestrant... xF Monitor is a ctDNA assay that tracks changes in quantitative ctDNA TF and simultaneously monitors for the emergence of ESR1m, providing a diagnostic that identifies resistance to AI therapy and enables early switch to therapies that could improve outcomes in a patient population with poor prognosis. A larger prospective clinical study is needed to validate these findings.
Clinical • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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HER-2 negative • ER mutation • ESR1 mutation
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Tempus xF Assay • Tempus xF Monitor assay
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fulvestrant
22d
A novel combination of tissue-informed, comprehensive genomic profiling (CGP) and non-bespoke blood-based profiling for quantifying circulating tumor DNA (ctDNA) (AACR 2024)
Here we introduce a novel sensitive and specific tumor-informed, non-bespoke approach for estimating ctDNA TF. Linearity improves with increased panel size and increased variant number. These results suggest that a tumor-informed ctDNA TF can be utilized to improve the sensitivity of existing methods for estimating tumor fraction to help in treatment decisions using Tempus' tissue and liquid comprehensive NGS genomic profiling platform.
Circulating tumor DNA
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Tempus xT Assay • Tempus xF Assay
5ms
ESR1 mutations drive resistance to CDK4/6 inhibitors in ER+ Breast Cancer. (SABCS 2023)
When treated with palbociclib + fulvestrant or palbociclib + estrogen-free medium (mimicking estrogen suppression in patients treated with aromatase inhibitors), cells harboring the Y537S and D538G mutations displayed an 11.2 to 46.9-fold increase in the IC50 of palbociclib. ESR1 mutations are enriched following treatment with CDK4/6i in a cohort of 3,958 patients with ER+/HER2- metastatic breast cancer. Mutations in ESR1 in ER+ breast cancer cells directly promote resistance to CDK4/6i alone or CDK4/6i + antiestrogens in vitro and in vivo.
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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HER-2 negative • HER-2 mutation • ER mutation • ER Y537S • ER D538G • ESR1 mutation • CDK4 mutation
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Tempus xT Assay • Tempus xF Assay
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Ibrance (palbociclib) • fulvestrant
5ms
Circulating Tumor DNA as a Biomarker for ADCs in Metastatic Breast Cancer (SABCS 2023)
Notably, only one patient received sequential ctDNA testing, and in that case, there was a gain of TP53 p.N239S following sacituzumab govitecan administration compared to the baseline ctDNA test, followed by a gain of PIK3CA p.P449_L455del after trastuzumab deruxtecan administration. As we observe changes in subtypes following treatment progression, researchers are actively seeking biomarkers to better characterize real-time changes in tumor biology that can predict response and resistance to treatments. Further studies are needed to identify additional genes present in ctDNA that can provide mechanistic insights into why certain patients respond favorably to ADCs while others do not. We are currently enrolling patients for a prospective study that aims to assess baseline ctDNA levels and monitor changes in variant allele frequency following treatment with ADCs and immunotherapy.
IO biomarker • Circulating tumor DNA • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • NF1 (Neurofibromin 1) • FGFR4 (Fibroblast growth factor receptor 4) • PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1) • RHOA (Ras homolog family member A) • GATA3 (GATA binding protein 3) • HNF1A (HNF1 Homeobox A)
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HER-2 positive • TP53 mutation • KRAS mutation • HR positive • BRAF mutation • PIK3CA mutation • HER-2 expression • PTEN mutation • NF1 mutation • PIK3R1 mutation
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Tempus xF Assay
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Enhertu (fam-trastuzumab deruxtecan-nxki) • Trodelvy (sacituzumab govitecan-hziy)
5ms
Tempus announces eight abstracts accepted for presentation at the 2023 Society for Immunotherapy of Cancer Annual Meeting (Tempus Press Release)
"Tempus...announced eight abstracts were accepted for presentation at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting, which convenes in San Diego, California, from November 1-5, 2023."
Clinical data
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Tempus xF Assay
6ms
Circulating Tumor DNA for Early Risk Stratification of Oligometastatic Lung Cancer. (PubMed, Int J Radiat Oncol Biol Phys)
These data suggest that liquid biopsy ctDNA detection represents a powerful pre-RT biomarker to risk-stratify oligometastatic NSCLC patients and potentially enable personalized decision-making for local consolidative RT.
Journal • Tumor mutational burden • Circulating tumor DNA • Metastases
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TMB (Tumor Mutational Burden)
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Tempus xF Assay
6ms
Pre-radiotherapy ctDNA liquid biopsy for risk stratification of oligometastatic non-small cell lung cancer. (PubMed, NPJ Precis Oncol)
Overall, these data suggest that in patients with oligometastatic NSCLC, pre-RT ctDNA can potentially identify the patients most likely to benefit from locally consolidative RT and experience prolonged PFS and OS. Similarly, ctDNA may be useful to identify undiagnosed micrometastatic disease where it may be appropriate to prioritize systemic therapies.
Journal • Tumor mutational burden • Liquid biopsy • Circulating tumor DNA • Metastases • Biopsy
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TMB (Tumor Mutational Burden)
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Tempus xF Assay
6ms
Association of a novel circulating tumor fraction DNA biomarker of treatment response monitoring and clinical outcomes in a real-world, diverse pan-cancer cohort treated with immunotherapy (SITC 2023)
Conclusions xF Monitor is a novel serial quantitative cTFE algorithm off the Tempus xF assay that has the potential to be used clinically as a predictive biomarker to stratify patients who are likely to benefit from ICI therapy, sparing ineffective therapeutic approaches. The xF Monitor biomarker needs to be prospectively validated in a larger cohort.
Real-world evidence • Clinical data • Clinical • IO biomarker • Pan tumor • Real-world
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Tempus xF Assay
7ms
Circulating Tumor DNA for Early Risk Stratification of Oligometastatic Lung Cancer (ASTRO 2023)
These data suggest that liquid biopsy ctDNA detection represents a powerful pre-RT biomarker to risk-stratify oligometastatic NSCLC patients and potentially enable personalized decision-making for local consolidative RT.
Tumor mutational burden • Circulating tumor DNA • Metastases
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TMB (Tumor Mutational Burden)
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Tempus xF Assay
9ms
Tempus Announces the GEMINI Non-Small Cell Lung Cancer Study (Businesswire)
"Tempus...announces its GEMINI Non-small Cell Lung Cancer (NSCLC) study (NCT05236114). The Tempus-sponsored study, being run in collaboration with AstraZeneca, aims to create a robust multi-omic dataset for patients with NSCLC to facilitate future novel research related to precision medicine, diagnostic development, and biomarker discovery....Patients enrolled in the trial will be studied for up to three years to assess the impact of their underlying tumor biology on disease progression and therapy efficacy. The results of this study will be used for biomarker discovery, including potential use of circulating tumor DNA (ctDNA) testing to measure MRD."
Trial status • Licensing / partnership
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Tempus xT Assay • Tempus xF Assay
11ms
Olaparib (O) in advanced triple negative breast cancer (aTNBC) patients (pts) with BRCA1/2 promoter methylation: GEICAM/2015-06 study (COMETA-Breast). (ASCO 2023)
In this proof-of-concept study, O did not show clinically nor statistically significant antitumor activity in pretreated aTNBC pts with BRCA1/2-meth. Clinical trial information: NCT03205761. >*7 pts had ≥3 CT lines.
Clinical • PARP Biomarker • BRCA Biomarker • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PMS2 (PMS1 protein homolog 2) • BRCA (Breast cancer early onset)
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BRCA2 mutation • BRCA1 mutation • HER-2 negative • BRCA1 promoter methylation
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Tempus xE • Tempus xF Assay
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Lynparza (olaparib)
11ms
Associations between androgen-directed treatments and AR mutational landscapes in the circulating tumor DNA of a real-world metastatic prostate cancer cohort. (ASCO 2023)
AR mutations have implications for clinical decision making and drug development in patients treated with abiraterone and/or enzalutamide. >1n (%).
Real-world evidence • Clinical • Circulating tumor DNA • Real-world • Metastases
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AR mutation • AR T878A • AR F877L • AR H875Y • AR L702H
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Tempus xF Assay
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enzalutamide capsule • abiraterone acetate
1year
Pre-radiotherapy ctDNA risk-stratifies non-small cell lung cancer patients with oligometastatic disease (AACR 2023)
These data suggest that a ctDNA-informed approach may be a powerful pre-RT biomarker to help risk-stratify oligometastatic NSCLC patients and potentially enable personalized decision-making for RT versus systemic therapy.
Clinical • Circulating tumor DNA • Metastases
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Tempus xF Assay
1year
Homologous recombination repair (HRR) mutation concordance between liquid biopsy (LB) and tumor tissue by NGS in a real-world prostate cancer (PC) database. (ASCO-GU 2023)
"In this large RW dataset, plasma ctDNA-based analysis of BRCA1, BRCA2, and ATM mut showed greater concordance between LB and MT than LB and PT, and may be used as an initial tool for HRR mut detection. When LB results are negative, further exploration with tissue-based testing may identify HRR mut to guide clinical decisions. >"
Real-world evidence • Clinical • Liquid biopsy
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
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Tempus xT Assay • Tempus xF Assay
1year
Role of adenomatous polyposis coli (APC) gene in SPOP-mutant prostate cancer and clinical outcomes. (ASCO-GU 2023)
In SPOPMT PCs, inactivation of APC is a common event and associated with more aggressive disease (higher metastatic potential and faster progression to castration resistance). This observation may help identify SPOPMT PC patients who are at higher risk for early castration resistance and could benefit from more intensive treatment.
Clinical data • Clinical
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AR (Androgen receptor) • APC (APC Regulator Of WNT Signaling Pathway) • SPOP (Speckle Type BTB/POZ Protein)
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APC mutation • SPOP mutation
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Tempus xT Assay • Tempus xF Assay
1year
Pathogenic BRAF mutations in prostate cancer: Frequency and distribution. (ASCO-GU 2023)
This study presents the first large-scale genomic characterization of BRAF mutations in patients with prostate cancer using both tissue and ctDNA NGS analysis. Among thousands of samples from prostate cancer patients, K601E was the most common BRAF mutation. This confirms findings of smaller studies and has implications for developmental therapeutics.
BRAF (B-raf proto-oncogene)
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BRAF V600E • BRAF mutation • BRAF V600 • BRAF K601E • BRAF K601
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Tempus xT Assay • Tempus xF Assay
over1year
Genomic analysis of circulating tumor DNA (ctDNA) from patients with HR+, HER2-mutant metastatic breast cancer (MBC) enrolled in SUMMIT: mechanisms of acquired resistance to neratinib + fulvestrant + trastuzumab (N+F+T) (SABCS 2022)
Similarities and differences between the mechanisms of acquired resistance to N+F+T, and those previously reported to be associated with progression on N or N+F, will be discussed.
Preclinical • Clinical • Circulating tumor DNA
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 amplification • HER-2 negative • CDK4 mutation
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Tempus xF Assay
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Herceptin (trastuzumab) • Nerlynx (neratinib) • fulvestrant
over1year
DelPHI: Delivering Precision Health Insights for Timely Diagnosis and Treatment of Epithelioid Sarcoma Using Protean MAPS and NAVIFY Digital Tools (AMP 2022)
P2 | "Notably, a complete SMARCB1/INI1 deletion (targetable by tazemetostat) was identified... NGS in conjunction with OGM demonstrated improved detection of clinically actionable alterations for this patient. Thus, both tests should be routinely considered as a part of the diagnostic regimen to better characterize key mutations in rare tumors and uncover actionable targets for treatment. Combining multiple types of molecular analyses uncovered that this patient was eligible for a novel clinical trial."
PD-L1 (Programmed death ligand 1) • SMARCB1 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily B, Member 1) • MUTYH (MutY homolog)
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SMARCB1 deletion
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FoundationOne® Heme CDx • Tempus xF Assay
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Tazverik (tazemetostat)
over1year
Dual ctDNA and tissue sequencing improves detection of actionable variants in breast cancer patients (SABCS 2022)
We show that dual testing in breast cancer patients improves the identification of clinically actionable variants which may be missed by either ctDNA or solid tissue biopsy alone. Adoption of dual testing should be considered as standard practice to provide a comprehensive view of actionable molecular alterations.
Clinical • Circulating tumor DNA
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ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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Tempus xT Assay • Tempus xF Assay
over1year
Genomic landscape of ER+/HER2- metastatic breast cancer as a function of prior treatment with a CDK4/6 inhibitor (SABCS 2022)
Background: CDK4/6 inhibitors (CDK4/6i), like palbociclib, ribociclib, and abemaciclib, along with antiestrogens, have revolutionized treatment for ER+/HER2- metastatic breast cancer (MBC). CCND1, FGF3, FGF4 and FGF19 alterations were copy number amplifications, which may be consistent with 11q13 amplification. Further studies will provide insights into how these trends translate towards our understanding of CDK4/6i related resistance mechanisms.
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • CCND1 (Cyclin D1) • FGF19 (Fibroblast growth factor 19) • FGF3 (Fibroblast growth factor 3) • FGF4 (Fibroblast growth factor 4) • GATA3 (GATA binding protein 3)
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TP53 mutation • HER-2 negative • HER-2 mutation • ER mutation • ESR1 mutation
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Tempus xT Assay • Tempus xF Assay
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Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib)
almost2years
Longitudinal Shifts of Solid Tumor and Liquid Biopsy Sequencing Concordance in Metastatic Breast Cancer. (PubMed, JCO Precis Oncol)
"We observed high concordances between tissue and cfDNA results that generally decreased with longer durations between tests. Thus, cfDNA NGS reliably measures tissue genomics and is likely beneficial for longitudinal monitoring of molecular changes in mBC."
Journal • Liquid biopsy
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Tempus xT Assay • Tempus xF Assay
almost2years
Dual tissue and plasma testing to improve detection of actionable variants in patients with solid cancers. (ASCO 2022)
"In the largest study of its kind, we show that dual tumor tissue and ctDNA testing—with samples collected either concurrently or longitudinally—identified more patients with actionable alterations than single modality testing alone and therefore should be considered as part of routine NGS testing. Additional studies to explore the genetic and intra-patient tumor heterogeneity of these variants as well as the impact of time between tissue and plasma sampling assessments and implications for timing of therapeutic recommendations are underway."
Clinical
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Tempus xT Assay • Tempus xF Assay • Tempus xF+ Panel
almost2years
Circulating tumor DNA (ctDNA) determinants of improved outcomes in patients (pts) with advanced solid tumors receiving the ataxia telangiectasia and Rad3-related inhibitor (ATRi), RP-3500, in the phase 1/2a TRESR trial (NCT04497116). (ASCO 2022)
ctDNA testing is a reliable method to detect DNA damage repair LOF alterations but is limited to alterations and genes/exons covered by the ctDNA test. CH alterations are frequent, especially for ATM, thus matched normal analysis is preferred. Changes in ctDNA as early as 3 wks were associated with improved outcomes and may be useful for evaluating drug activity in heterogenous tumors outside of traditional efficacy endpoints.
P1/2 data • Clinical • PARP Biomarker • BRCA Biomarker • Circulating tumor DNA
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KRAS (KRAS proto-oncogene GTPase) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PALB2 (Partner and localizer of BRCA2) • CDK12 (Cyclin dependent kinase 12) • MUC16 (Mucin 16, Cell Surface Associated) • ATR (Ataxia telangiectasia and Rad3-related protein) • RAD51C (RAD51 paralog C)
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KRAS mutation • BRCA1 mutation • PALB2 mutation
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Guardant360® CDx • Tempus xF Assay • Tempus xF+ Panel
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camonsertib (RP-3500)
almost2years
Molecular profiles of gastric adenocarcinoma among Hispanic patients at a safety-net healthcare system. (ASCO 2022)
CDH1 mutations, which are associated with familial gastric cancers and more aggressive disease, were present in 33% of Hispanic patients with gastric adenocarcinoma in our study. Nearly half of these identified patients were younger than 50 years old. The high frequency of CDH1 mutations may contribute to the unique pathogenesis of gastric cancers in Hispanic patients.
Clinical
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MSI (Microsatellite instability) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ARID1A (AT-rich interaction domain 1A) • LRP1B (LDL Receptor Related Protein 1B) • SMAD4 (SMAD family member 4) • CDH1 (Cadherin 1) • RHOA (Ras homolog family member A)
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TP53 mutation • CDH1 mutation
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Tempus xT Assay • Tempus xF Assay • Tempus xF+ Panel
almost3years
[VIRTUAL] Landscape of KRASG12C, associated genomic alterations, and interrelation with immuno-oncology (IO) biomarkers. (ASCO 2021)
Background: Sotorasib has shown promising activity in cancer patients (pts) specifically harboring the KRASG12C mutation... Our data suggest that KRAS variants significantly differ by cancer type . Tumors harboring KRASG12C were significantly associated with high TMB and PD-L1 overexpression . KRASG12C mutation appeared to be associated with smoking status .
Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • STK11 (Serine/threonine kinase 11) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • KEAP1 (Kelch Like ECH Associated Protein 1) • SMAD4 (SMAD family member 4)
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BRAF V600E • KRAS mutation • TMB-H • PD-L1 overexpression • MSI-H/dMMR • KRAS G12C • KRAS G12D • KRAS G12V • KEAP1 mutation • KRAS G12 • KRAS G13 • TMB-H + PD-L1 overexpression • KRAS overexpression
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Tempus xT Assay • Tempus xF Assay
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Lumakras (sotorasib)
almost3years
[VIRTUAL] Characterization of KRAS mutation variants and prevalence of KRAS-G12C in gastrointestinal malignancies (ESMO-GI 2021)
"Background The KRAS G12C inhibitor sotorasib has shown promising anticancer activity in patients with advanced solid tumors harboring the KRAS G12C mutation, holding the potential for transforming clinical management of KRAS mutated solid tumors...G12C was most frequently observed in patients with appendiceal, colorectal, small bowel, biliary, and pancreatic cancers. G12C was not detected in SCC of the esophagus or anal canal."
KRAS (KRAS proto-oncogene GTPase)
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KRAS mutation • KRAS G12C • KRAS G12D • KRAS G12V • KRAS G12A • KRAS G12 • KRAS G12S • KRAS Q61H
|
Tempus xT Assay • Tempus xF Assay
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Lumakras (sotorasib)
3years
Longitudinal and multi-tissue molecular diagnostics track somatic BRCA2 reversion mutations that correct the open reading frame of germline alteration upon clinical relapse. (PubMed, NPJ Genom Med)
"Both alterations restored the open reading frame of the original germline alteration, likely accounting for acquired resistance. This case exemplifies the evolution of multiple subclonal BRCA reversion alterations over time and demonstrates the value of longitudinal multi-tissue genomic testing for monitoring disease progression, predicting measures of response, and evaluating treatment outcomes in oncology patients."
Journal • Clinical
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BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
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BRCA mutation • BRCA2 N255fs
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Tempus xT Assay • Tempus xF Assay