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TEST:
PredicineATLAS™

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

News

10ms
Integrated longitudinal circulating tumor DNA profiling predicts immunotherapy response of metastatic urothelial carcinoma in the POLARIS-03 trial. (PubMed, J Pathol)
POLARIS-03 is a multicenter phase II trial to evaluate the safety and efficacy of toripalimab (anti-programmed cell death 1) in refractory metastatic urothelial carcinoma (mUC)...This study demonstrates the feasibility and effectiveness of integrated longitudinal ctDNA profiling as a potential biomarker in mUC patients undergoing immunotherapy and supports further clinical evaluation of minimally invasive liquid biopsy assays for treatment stratification and therapy monitoring.
Journal • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA • Metastases
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MSI (Microsatellite instability) • FGFR3 (Fibroblast growth factor receptor 3) • TACC3 (Transforming acidic coiled-coil containing protein 3)
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FGFR3 fusion
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PredicineATLAS™
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Loqtorzi (toripalimab-tpzi)
over1year
Comparative genomic profiling and disease monitoring in unresectable gastric and colon cancer (AACR 2023)
"This study compared the variation landscape between gastric and colon cancer patients, and demonstrated the technical feasibility of genome-wide copy number variations through liquid biopsy, revealing its potential clinical utility of longitudinal disease monitoring."
KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden)
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KRAS mutation • PIK3CA mutation • PIK3CA mutation + KRAS mutation
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PredicineATLAS™ • PredicineCNB™
over1year
Development and validation of blood tumor mutational burden reference standards. (PubMed, Genes Chromosomes Cancer)
A bioinformatic filtration step was required to account for low VAF artefact variants. We demonstrate the feasibility and challenges of producing and using bTMB reference standards across a range of bTMB levels, and how such standards could support the calibration and validation of bTMB platforms and help harmonization between panels and laboratories.
Journal • Tumor Mutational Burden • IO biomarker
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TMB (Tumor Mutational Burden)
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GuardantOMNI • PredicineATLAS™
almost2years
Predicine to present new data at ESMO 2022 demonstrating the utility of its portfolio of liquid biopsy tests for cancer patients (Predicine Press Release)
"Predicine, Inc.,.announced...that it will present four posters at the ESMO conference being held September 9-13, 2022, in Paris, France...Predicine is delighted to present at the ESMO conference and to introduce the full suite of liquid biopsy solutions, highlighting the PredicineATLAS 600 gene assay, PredicineBEACON personalized MRD assay, PredicineCNB assay for longitudinal Copy Number Burden assessment, and PredicineEPIC methylation assay."
Clinical data
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PredicineATLAS™ • PredicineBEACON™
almost2years
Comparative analysis of urinary and tissue tumor DNA in muscle-invasive bladder cancer by boosted whole-exome sequencing (ESMO 2022)
Conclusions This study demonstrates the effectiveness of urinary tumor DNA as a tissue surrogate for mutation profiling in MIBC at the whole-exome scale, supporting urine-based noninvasive molecular profiling in precision medicine for patients with bladder cancer. PredicineWES+ assay enables accurate detection of subclonal mutations from urine samples and enables the detection of urine-based personalized minimal residual diseases (MRD) in MIBC.
TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR3 (Fibroblast growth factor receptor 3) • ARID1A (AT-rich interaction domain 1A) • TERT (Telomerase Reverse Transcriptase) • KMT2D (Lysine Methyltransferase 2D)
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TP53 mutation • PIK3CA mutation • ARID1A mutation • TERT mutation
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PredicineATLAS™ • PredicineWES+™
2years
Predicine liquid biopsy outperforms four other leading ctDNA NGS tests in a study by Bristol Myers Squibb (PRNewswire)
"Predicine...announced the results of a new research study that demonstrated superior performance of the PredicineATLAS™ liquid biopsy next-generation sequencing (NGS) assay compared to four other leading liquid biopsy assays for key metrics. The manuscript, 'Direct comparison of circulating tumor DNA sequencing assays with targeted large gene panels,' was released online ahead of publication in PLOS ONE."
Clinical data
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PredicineATLAS™
over2years
Blood tumor mutational burden (bTMB) and blood copy number burden (bCNB) by genome-wide circulating tumor DNA (ctDNA) assessment predict outcome and resistance in hormone-receptor positive (HR+), HER2 negative (HER2-) metastatic breast cancer (MBC) patients (pts) treated with CDK4/6 inhibitor (CDK4/6 i ) (SABCS 2021)
P2 | " We collected serial blood for ctDNA testing from the 51 pts with HR+, HER2- MBC enrolled in the Alt Dose Palbo trial (NCT03007979), a single-arm phase II study of palbociclib plus letrozole or fulvestrant at 5 days on/2 days off weekly schedule as the first- or second-line ET. Our study also discovered novel candidate genes involved in cell cycle and DNA damage repair pathways in association with poor outcome. Results from this study highlight the genomic heterogeneity of HR+, HER2- MBC and provide important insights in the understanding of CDK4/6 i and ET resistance mechanisms to guide therapeutic development in pts with resistant disease."
Clinical • Circulating tumor DNA
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TMB (Tumor Mutational Burden) • BRCA2 (Breast cancer 2, early onset) • RB1 (RB Transcriptional Corepressor 1) • CCND1 (Cyclin D1) • FGFR4 (Fibroblast growth factor receptor 4) • CDK4 (Cyclin-dependent kinase 4) • RUNX1T1 (RUNX1 Partner Transcriptional Co-Repressor 1) • FAT1 (FAT atypical cadherin 1) • AURKA (Aurora kinase A) • ABCC2 (ATP Binding Cassette Subfamily C Member 2) • FOXP1 (Forkhead Box P1) • DDR2 (Discoidin domain receptor 2)
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HR positive • HER-2 negative
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PredicineATLAS™
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Ibrance (palbociclib) • fulvestrant • letrozole
almost3years
[VIRTUAL] Longitudinal circulating tumor DNA profiling of metastatic urothelial carcinoma in the POLARIS-03 trial (ESMO 2021)
POLARIS-03 is a multicenter phase II trial to evaluate the safety and efficacy of toripalimab (anti-PD-1) in refractory metastatic urothelial carcinoma (mUC)... This study demonstrates the feasibility and effectiveness of bTMB as a potential biomarker for mUC patients undergoing immunotherapy, and supports clinical application of PredicineATLAS liquid biopsy assay as a minimally invasive tool for treatment stratification and therapy monitoring in mUC.
Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • FGFR3 (Fibroblast growth factor receptor 3) • TACC3 (Transforming acidic coiled-coil containing protein 3) • ZFHX3 (Zinc Finger Homeobox 3)
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TMB-H • FGFR3 fusion
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PredicineATLAS™
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Loqtorzi (toripalimab-tpzi)
over3years
[VIRTUAL] Blood-based genome-wide copy number analysis of 500 cancer patients (AACR 2021)
Our study demonstrates a cancer type-specific pattern of copy number variation across chromosome arms. The CNV abnormality score we developed in this study can be used to distinguish healthy person from cancer patient, and monitor disease progression for longitudinal patient samples.
Clinical
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PredicineATLAS™
over3years
[VIRTUAL] Circulating tumor DNA analysis of genomic alterations in metastatic urothelial carcinoma from NCT03113266 study. (ASCO-GU 2021)
Prospective ctDNA analysis using the PredicineATLAS liquid biopsy assay is feasible and represents a minimally invasive approach to detecting cancer-specific genetic landscape and potentially guiding personalized therapeutic decisions in mUC patients.
Tumor mutational burden • PD(L)-1 Biomarker • BRCA Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • PTEN (Phosphatase and tensin homolog) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • TACC3 (Transforming acidic coiled-coil containing protein 3) • KDM6A (Lysine Demethylase 6A) • PPM1D (Protein Phosphatase Mg2+/Mn2+ Dependent 1D)
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TP53 mutation • TMB-H • FGFR3-TACC3 fusion • FGFR1 fusion • FGFR3 fusion
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PredicineATLAS™
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Loqtorzi (toripalimab-tpzi)
over3years
[VIRTUAL] Predictive value of plasma tumor mutation burden (TMB) in the CCTG PA.7 trial: Gemcitabine (GEM) and nab-paclitaxel (Nab-P) vs. GEM, nab-P, durvalumab (D) and tremelimumab (T) as first line therapy in metastatic pancreatic ductal adenocarcinoma (mPDAC). (ASCO-GI 2021)
High TMB is associated with immunotherapy sensitivity, with a threshold of =10 mut/Mb receiving FDA accelerated approved for pembrolizumab in a tissue agnostic setting. Plasma TMB analysis was successful in over 99% of pts with available samples. Plasma TMB =9 mut/Mb was predictive of benefit from the addition of dual immune checkpoint inhibitors (D and T) to Gem and Nab-P, with a significant interaction p-value. While only present in a subgroup of pts (4.6%), this data defines a group beyond MSI-H PDAC that may benefit from immunotherapy.
Clinical • Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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TMB-H • MSI-H/dMMR • TMB-L
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PredicineATLAS™
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Keytruda (pembrolizumab) • Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • Imjudo (tremelimumab)
over3years
[VIRTUAL] Predictive value of plasma tumor mutation burden (TMB) in the CCTG PA.7 trial: Gemcitabine (GEM) and nab-paclitaxel (Nab-P) vs. GEM, nab-P, durvalumab (D) and tremelimumab (T) as first line therapy in metastatic pancreatic ductal adenocarcinoma (mPDAC). (ASCO-GI 2021)
High TMB is associated with immunotherapy sensitivity, with a threshold of =10 mut/Mb receiving FDA accelerated approved for pembrolizumab in a tissue agnostic setting. Plasma TMB analysis was successful in over 99% of pts with available samples. Plasma TMB =9 mut/Mb was predictive of benefit from the addition of dual immune checkpoint inhibitors (D and T) to Gem and Nab-P, with a significant interaction p-value. While only present in a subgroup of pts (4.6%), this data defines a group beyond MSI-H PDAC that may benefit from immunotherapy.
Clinical • Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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TMB-H • MSI-H/dMMR • TMB-L
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PredicineATLAS™
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Keytruda (pembrolizumab) • Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • Imjudo (tremelimumab)
over3years
[VIRTUAL] Development and validation of blood tumor mutational burden reference standards (SITC 2020)
The data highlight the importance of data filtration to account for underlying low MAFs in such cell-line derived samples and that this reference material can control for variant sensitivity though not variant specificity. bTMB reference standards reported here could support the calibration and validation of bTMB platforms and help harmonization between panels and laboratories, thus improving the accuracy of testing to aid treatment decisions in oncology.
Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
|
TMB (Tumor Mutational Burden)
|
GuardantOMNI • PredicineATLAS™
over3years
[VIRTUAL] Development and validation of blood tumor mutational burden reference standards (SITC 2020)
The data highlight the importance of data filtration to account for underlying low MAFs in such cell-line derived samples and that this reference material can control for variant sensitivity though not variant specificity. bTMB reference standards reported here could support the calibration and validation of bTMB platforms and help harmonization between panels and laboratories, thus improving the accuracy of testing to aid treatment decisions in oncology.
Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
|
TMB (Tumor Mutational Burden)
|
GuardantOMNI • PredicineATLAS™
over3years
[VIRTUAL] Germline mutation landscape in Chinese breast cancer patients (SABCS 2020)
This is a comprehensive analysis of germline mutation spectrum in a large Chinese patient cohort with breast cancer. Collectively, a substantial proportion of patients with breast cancer had hereditary risk factors. Distinct distribution of pathogenic mutations in breast cancer subtypes and differential associations between mutation status and clinical features were further observed.
Clinical • BRCA Biomarker
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TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • PMS2 (PMS1 protein homolog 2) • CHEK2 (Checkpoint kinase 2) • RAD50 (RAD50 Double Strand Break Repair Protein) • BARD1 (BRCA1 Associated RING Domain 1) • FANCM (FA Complementation Group M) • FANCD2 (FA Complementation Group D2)
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BRCA2 mutation • BRCA1 mutation • ATM mutation • CHEK2 mutation • PMS2 mutation • RAD50 mutation • BARD1 mutation • FANCM mutation
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PredicineATLAS™