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TEST:
PredicineCARE™

Company:
Predicine
Type:
CE Marked
Related tests:
Evidence

News

23d
Genomic profiling of colorectal cancer - insights from liquid biopsy comparisons between U.S. and China cohorts (AACR 2024)
This study reveals the extensive mutational landscape in advanced colorectal cancer patients through liquid biopsy. Distinct prevalence patterns in certain genes between the U.S. and China cohorts offer novel biomarkers for clinical diagnosis and provide insights for targeted therapy mechanism studies.
Liquid biopsy • Biopsy
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • GNAS (GNAS Complex Locus)
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PredicineCARE™
23d
Comprehensive genomic profiling of advanced breast cancer subtypes: Insights from liquid biopsy analysis and implications for personalized therapies (AACR 2024)
This study offers insights into the genomic landscape of advanced breast cancer subtypes through liquid biopsy. The observed prevalence of PIK3CA mutations supports the potential efficacy of PI3K inhibitors across these diverse types of breast cancer, laying the groundwork for personalized therapeutic strategies and biomarker identification for prognosis and targeted therapies.
Liquid biopsy • BRCA Biomarker • Metastases • Biopsy
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HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA2 (Breast cancer 2, early onset) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • FGFR1 (Fibroblast growth factor receptor 1) • RAD50 (RAD50 Double Strand Break Repair Protein)
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HER-2 positive • TP53 mutation • HR positive • PIK3CA mutation • PIK3CA E545 • PIK3CA H1047 • PIK3CA E542
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PredicineCARE™
23d
Comparative genomic profiling of unresectable NSCLC patients in the U.S. and China using a globally harmonized liquid biopsy assay platform (AACR 2024)
This study unveils the mutational landscape of advanced NSCLC through liquid biopsy. Unique prevalence patterns between U.S. and China cohorts suggest novel biomarkers for clinical diagnosis and provide insights for targeted therapy mechanism studies.
Clinical • Liquid biopsy • Biopsy
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • RB1 (RB Transcriptional Corepressor 1)
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PredicineCARE™
23d
Monitoring glioma treatment response through longitudinal analysis of cell-free DNA in cerebrospinal fluid: Insights from a comprehensive study using next-generation sequencing (AACR 2024)
Subsequently, CSF cfDNA decreased during chemoradiation and adjuvant treatment and increased at recurrence, even in patients co-enrolled in immunotherapy trials for IL-7 agonists and pembrolizumab... Analysis of cfDNA throughout a patient's disease course, encompassing resection and treatment with standard-of-care and experimental therapies, may aid in disease monitoring and treatment response. Further evaluation in a larger patient cohort is needed to determine the sensitivity of changes in mutations, CNB, and cfDNA quantity for glioma disease burden.
Next-generation sequencing • PD(L)-1 Biomarker • IO biomarker • Cell-free DNA
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EGFR (Epidermal growth factor receptor) • MAP2K1 (Mitogen-activated protein kinase kinase 1) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • IL7 (Interleukin 7)
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EGFR amplification
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PredicineCARE™
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Keytruda (pembrolizumab)
3ms
Predicine Announces Collaboration with Janssen to Develop PredicineCARE as a Companion Diagnostic Assay in Localized Bladder Cancer (GlobeNewswire)
"Predicine...announced a collaboration with Janssen Pharmaceutica NV (Janssen), a Johnson & Johnson company. This collaboration focuses on the development of the PredicineCARE™ urine cell-free DNA (cfDNA) next-generation sequencing (NGS) assay as a companion diagnostic to identify patients who may benefit from targeted therapy....PredicineCARE™ is a comprehensive, state-of-the-art NGS assay that interrogates point mutations/indels, fusions, amplifications, and gene deletions in key cancer-associated genes using cfDNA in urine."
Licensing / partnership
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PredicineCARE™
4ms
A prospective study of comprehensive genomic testing to identify actionable variants in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2024)
Of the 42 pts with a treatment recommendation, 23 pts (56%) have received an on-label treatment, 19 with a PARP inhibitor and 4 with pembrolizumab... In this prospective study, 38% of pts with mCRPC were identified to have variants with an on-label treatment recommendation, highlighting the value of comprehensive testing to identify a relatively high number of these pts. In pts with both cfDNA and tissue testing, cfDNA alone detected 68% of these pts, emphasizing the value of cfDNA as a complement or alternative to tissue testing. Repeat cfDNA testing in a cohort of pts detected a new on-label variant in almost half of the pts tested, emphasizing the potential value of serial testing with tumor progression.
Clinical • PD(L)-1 Biomarker • PARP Biomarker • MSi-H Biomarker • BRCA Biomarker • BRCA Companion diagnostic • MSi-H Companion diagnostic • PARP Companion diagnostic • PD(L)-1 companion diagnostic • Metastases
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2)
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MSI-H/dMMR • BRCA2 deletion • BRCA1 deletion
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PredicineCARE™
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Keytruda (pembrolizumab)
4ms
Pharmacodynamics and gene expression analysis of patients with renal cell carcinoma treated with combination nivolumab and TPST-1120 in a phase I clinical trial (NCT03829436). (ASCO-GU 2024)
There is a paucity of treatment options for patients with stage IV RCC post anti-PD1 and anti-VEGF therapies. Novel therapies on this clinical scenario are needed. On this abstract we showed radiographic and pharmacodynamic data on patients with RCC who achieved a clinical partial response by RECIST on the phase I clinical trial TPST1120-001.
PK/PD data • Clinical • PD(L)-1 Biomarker • IO biomarker
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ACSL3 (Acyl-CoA Synthetase Long Chain Family Member 3) • FABP1 (Fatty Acid Binding Protein 1)
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PredicineCARE™
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Opdivo (nivolumab) • TPST-1120
4ms
Urine-based testing for patient selection and genomic characterization of patients with FGFR alteration-positive non–muscle-invasive bladder cancer (NMIBC) treated with TAR-210. (ASCO-GU 2024)
Implementing a urine-based assay expands the molecular testing methods to identify additional patients that may respond to erdafitinib. Results justify further study. Clinical trial information: NCT05316155.
Clinical
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FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor)
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FGFR3 S249C
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therascreen® FGFR RGQ RT-PCR Kit • PredicineCARE™
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erdafitinib intravesical delivery system (TAR-210)
4ms
Development and application of an ultra-sensitive ctDNA mutation profiling assay in monitoring therapy response and drug resistance. (ASCO-GI 2024)
This assay was then adopted for longitudinal sequencing of 57 serial plasmas from 6 patients with HER2+ gastroesophageal adenocarcinomas (GEC) who underwent combined treatments (capecitabine, oxaliplatin, bevacizumab and trastuzumab) at different time points (baseline, response, and progression). This study demonstrated the promise and clinical utility of the ultra-sensitive cfDNA molecular profiling at 100,000X sequencing depth in treatment selection, therapy monitoring, and drug resistance studies.
Circulating tumor DNA
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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)
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TP53 mutation • KRAS mutation • PIK3CA mutation • HER-2 mutation
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PredicineCARE™
|
Avastin (bevacizumab) • Herceptin (trastuzumab) • capecitabine • oxaliplatin
4ms
Liquid biopsy-based comprehensive genomic profiling to reveal mutational landscape in real-world patients with gastrointestinal cancer. (ASCO-GI 2024)
This study elucidated the comprehensive mutational landscape of advanced gastrointestinal cancer through liquid biopsy, thereby contributing novel biomarkers for clinical diagnosis and facilitating targeted therapy mechanism investigations.
Real-world evidence • Clinical • Tumor mutational burden • BRCA Biomarker • Liquid biopsy • Real-world • Biopsy
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • ARID1A (AT-rich interaction domain 1A) • MLH1 (MutL homolog 1) • FGFR4 (Fibroblast growth factor receptor 4) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • PMS2 (PMS1 protein homolog 2) • FAT1 (FAT atypical cadherin 1) • EPCAM (Epithelial cell adhesion molecule) • ERCC5 (ERCC Excision Repair 5 Endonuclease 2)
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EGFR mutation • HRD • MSH6 mutation • MSH2 mutation • MLH1 mutation • PMS2 mutation
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PredicineCARE™
5ms
Enrollment open
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MET (MET proto-oncogene, receptor tyrosine kinase)
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MET amplification
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PredicineCARE™
|
Tabrecta (capmatinib)
5ms
Predicine announces six studies showcasing MRD and liquid biopsy innovations at ESMO 2023 (GlobeNewswire)
"Predicine...announce its participation in the European Society for Medical Oncology (ESMO) 2023 Congress in Madrid, Spain. The company will present six compelling poster studies, unveiling the future of liquid biopsy solutions...These poster presentations will shine a spotlight on Predicine’s groundbreaking liquid biopsy innovations, including PredicineBEACON™, a revolutionary solution for personalized and actionable minimal residual disease (MRD) analysis."
Real-world evidence • Clinical data
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PredicineBEACON™ • PredicineCARE™ • PredicineWES+™
8ms
Central Nervous System Efficacy of Capmatinib in NSCLC With Brain Metastases With cfDNA Positive MET Alterations (clinicaltrials.gov)
P2; Trial completion date: May 2028 --> Sep 2028 | Initiation date: May 2023 --> Sep 2023 | Trial primary completion date: May 2026 --> Sep 2026
Trial completion date • Trial primary completion date • Trial initiation date
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MET (MET proto-oncogene, receptor tyrosine kinase)
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MET amplification
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PredicineCARE™
|
Tabrecta (capmatinib)
8ms
BRCA-deficient metastatic prostate cancer has an adverse prognosis and distinct genomic phenotype. (PubMed, EBioMedicine)
These data emphasise that the BRCA genes, in particular BRCA2, are key prognostic biomarkers in mCRPC. The clinical utility of BRCA2 as a marker of poor outcomes may, at least in cfDNA assays, be independent of the zygosity state detected. Enrichment of actionable genomic alterations in cfDNA from BRCA-deficient mCRPC may support rational co-targeting strategies in future clinical trials.
Journal • BRCA Biomarker • Metastases
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset) • CHEK2 (Checkpoint kinase 2) • FANCA (FA Complementation Group A)
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BRCA2 mutation
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PredicineCARE™
8ms
Urine-based comprehensive genomic profiling reveals mutational landscape in real-world patients with bladder cancer (ESMO 2023)
Conclusions The present study unveils a comprehensive mutational landscape of non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) utilizing urine samples from real-world patients. These results demonstrate the promising potential of urine-based next-generation sequencing (NGS) assays to identify tumor-derived variants for clinical diagnosis and targeted treatment.
Real-world evidence • Clinical • BRCA Biomarker • Real-world
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HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA2 (Breast cancer 2, early onset) • FGFR2 (Fibroblast growth factor receptor 2) • ARID1A (AT-rich interaction domain 1A) • TERT (Telomerase Reverse Transcriptase)
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TP53 mutation • PIK3CA mutation • HER-2 mutation • ARID1A mutation • FGFR2 mutation
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PredicineCARE™
8ms
Detection of molecular recurrence in early-stage bladder cancer patients using a urinary tumor DNA assay after transurethral resection of bladder tumor (TURBT) (ESMO 2023)
Conclusions The results of this study confirm the validity of utilizing a utDNA assay to detect molecular recurrence in early-stage bladder cancer patients who have undergone TURBT treatment, which can be instrumental in facilitating early detection of tumor recurrence and guiding treatment decisions. These findings underscore the enormous potential of urine-based NGS assays for urothelial cancer detection and disease surveillance.
Clinical
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TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ARID1A (AT-rich interaction domain 1A) • ERCC2 (Excision repair cross-complementation group 2) • KDM6A (Lysine Demethylase 6A)
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PredicineCARE™
8ms
Comprehensive genomic profiling of advanced HR+/HER2- breast cancer patients using liquid biopsy (ESMO 2023)
Conclusions This study presents a comprehensive analysis of the mutational landscape of advanced HR+/HER2- breast cancer patients using liquid biopsy. Additionally, it compares the molecular profiles of patients with different clinical features receiving diverse treatments, thus identifying potential biomarkers for prognosis and targeted therapies.
Clinical • BRCA Biomarker • Liquid biopsy • Metastases • Biopsy
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA2 (Breast cancer 2, early onset) • FAT1 (FAT atypical cadherin 1) • RAD50 (RAD50 Double Strand Break Repair Protein) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin))
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HER-2 negative • HER-2 mutation • RAD50 mutation
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PredicineCARE™
11ms
Detection of bladder cancer relapse after TURBT through urinary tumor DNA analysis: A prospective real-world evidence study. (ASCO 2023)
This study demonstrates the feasibility of using urine ctDNA assay to detect molecular recurrence in early-stage bladder cancer patients treated by TURBT. This information can be used to improve patient outcomes by enabling early detection of tumor recurrence and guiding treatment decisions. The findings of this study highlight the promising potential of urine-based NGS assays for cancer detection and disease surveillance.
Real-world evidence • HEOR • Clinical • Real-world
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HER-2 (Human epidermal growth factor receptor 2) • 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) • KMT2D (Lysine Methyltransferase 2D)
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TP53 mutation • FGFR3 fusion
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PredicineCARE™
11ms
Exploratory biomarker analysis of acelERA breast cancer (BC): Phase II study of giredestrant vs. physician’s choice of endocrine therapy (PCET) for previously treated, estrogen receptor-positive, HER2-negative advanced BC (ER+, HER2– aBC). (ASCO 2023)
Randomization was 1:1 to giredestrant (30 mg PO daily) or PCET (fulvestrant/aromatase inhibitor). These data show that tumor response to single-agent ET is correlated with baseline ctDNA features and with tumor ER pathway activity. Interestingly, ER pathway activity was significantly lower in late-line tumors, except in ESR1m tumors. Overall, these results support the continued investigation of improved and personalized treatment options for pts with ER+, HER2– aBC.
P2 data • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CHEK2 (Checkpoint kinase 2) • GATA3 (GATA binding protein 3)
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ER positive • HER-2 negative • ER mutation • CHEK2 mutation • ESR1 mutation • ER expression • ER positive + HER-2 negative
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FoundationOne® Liquid CDx • Prosigna™ Breast Cancer Prognostic Gene Signature Assay • PredicineCARE™
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fulvestrant • giredestrant (GDC-9545)
12ms
Central Nervous System Efficacy of Capmatinib in NSCLC With Brain Metastases With cfDNA Positive MET Alterations (clinicaltrials.gov)
P2; Trial completion date: Dec 2027 --> May 2028 | Trial primary completion date: Dec 2025 --> May 2026
Trial completion date • Trial primary completion date
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MET (MET proto-oncogene, receptor tyrosine kinase)
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MET amplification
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PredicineCARE™
|
Tabrecta (capmatinib)
12ms
Utility of Urinary Tumor DNA Detection in Treatment-Naïve UTUC (AUA 2023)
UTUC tumor variants are detectable in the urine of treatment-naïve patients undergoing RNU for UTUC using both a panel-based approach and WGS. utDNA detection and dynamics may present an opportunity for personalized monitoring of UTUC.
HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • FGFR3 (Fibroblast growth factor receptor 3)
|
PredicineCARE™
1year
Liquid biopsy-based comprehensive genomic profiling reveal mutational landscape in real-world patients with unresectable NSCLC (AACR 2023)
"This study revealed the comprehensive mutational landscape of advanced NSCLC through liquid biopsy, providing novel biomarkers for clinical diagnosis and targeted therapy mechanism studies."
Real-world evidence • Clinical • Liquid biopsy
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • RET (Ret Proto-Oncogene) • PTEN (Phosphatase and tensin homolog) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • EML4 (EMAP Like 4) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • RB1 (RB Transcriptional Corepressor 1) • NRG1 (Neuregulin 1) • KIF5B (Kinesin Family Member 5B) • CD74 (CD74 Molecule) • ETV6 (ETS Variant Transcription Factor 6) • NCOA4 (Nuclear Receptor Coactivator 4) • NTRK (Neurotrophic receptor tyrosine kinase)
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NTRK1 fusion • RET fusion • EML4-ALK fusion • ALK fusion • KIF5B-RET fusion • ETV6-NTRK3 fusion • NRG1 fusion • NCOA4-RET fusion • CD74-NRG1 fusion • NRG1 fusion • NTRK fusion
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PredicineCARE™
1year
Long term results and ctDNA correlatives for CAPOX BETR: A multi-center phase II trial of capecitabine, oxaliplatin, bevacizumab and trastuzumab for previously untreated HER2 positive metastatic gastroesophageal adenocarcinoma (AACR 2023)
"The combination of CAPOX, trastuzumab and bevacizumab shows striking clinical activity comparable to novel triplet regimens that include PD1 blockade for HER2+ GEAs . Further evaluation of VEGF mAb in combination with chemoimmunotherapy and anti-PD1 regimens is warranted. Diagnostic ctDNA profiling identifies cases with high TF and alternative MAPK drivers who have worse outcomes."
P2 data • Clinical • Circulating tumor DNA
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MET (MET proto-oncogene, receptor tyrosine kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • PTEN (Phosphatase and tensin homolog) • FGFR1 (Fibroblast growth factor receptor 1)
|
HER-2 positive • KRAS mutation • BRAF mutation • HER-2 amplification • NRAS mutation • MET amplification • PTEN mutation • FGFR1 amplification
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PredicineCARE™
|
Avastin (bevacizumab) • Herceptin (trastuzumab) • capecitabine • oxaliplatin
1year
Liquid biopsy-based comprehensive genomic profiling reveal mutational landscape in advanced breast cancer (AACR 2023)
"This study revealed the comprehensive mutational landscape of advanced breast cancer patients through liquid biopsy, providing novel biomarkers for clinical diagnosis and targeted therapy mechanism studies."
Liquid biopsy
|
TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • FGFR1 (Fibroblast growth factor receptor 1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • RB1 (RB Transcriptional Corepressor 1)
|
PTEN mutation
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PredicineCARE™
1year
Targeted liquid biopsy mutation profiling and genome-wide cfDNA copy-number landscape in 3000 samples from six major cancer indications (AACR 2023)
PredicineCARE has been CE-marked and received breakthrough device designation from FDA. A harmonized PredicineCARE assay is available in the US and China to support patient testing in the clinic, global clinical trials and CDx development.
IO biomarker • Liquid biopsy • Biopsy
|
PredicineCARE™
1year
Lipid and immune-based biomarkers associated with clinical response to TPST-1120: A small molecule antagonist of peroxisome-proliferator activated receptor-alpha (AACR 2023)
TPST-1120 was well tolerated and showed signs of activity in a phase I trial as monotherapy and in combination with nivolumab (NCT03829436). TPST-1120 treated patients with PR demonstrated fatty acid oxidation perturbations and immune gene expression changes as potential biomarkers of clinical benefit. Increased frequencies of responding patients bearing PI3K pathway or IDH mutations may reveal populations likely to benefit from treatment with TPST-1120. 1.
Clinical • PD(L)-1 Biomarker • IO biomarker
|
PTEN (Phosphatase and tensin homolog) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule) • APOE (Apolipoprotein E) • PPARA (Peroxisome Proliferator Activated Receptor Alpha)
|
PTEN mutation
|
PredicineCARE™ • nCounter® PanCancer Immune Profiling Panel
|
Opdivo (nivolumab) • TPST-1120
1year
Adverse clinical outcomes and distinct genomic phenotype of BRCA-deficient metastatic castration-resistant prostate cancer (mCRPC) (AACR 2023)
Additionally, on top of a high proportion of AR alterations, BRCA-defective cancers were also enriched in a number of potentially actionable targets and neuroendocrine markers. Clinical trials that leverage rational co-targeting strategies will provide an opportunity to enhance the efficacy of PARPi in mCRPC.
Clinical data • Adverse events • Clinical • PARP Biomarker • BRCA Biomarker • Metastases
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TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • BRCA (Breast cancer early onset)
|
PredicineCARE™
1year
Evaluating technical feasibility of a urine cell-free DNA (cfDNA) NGS assay for identifying biomarkers in bladder cancer. (ASCO-GU 2023)
Despite significant breakthroughs in targeted medicines (i.e., Erdafitinib, FGFR2/3 kinase inhibitor) and clinical care over the past decade, non-invasive molecular testing remains an unmet clinical need for the treatment of bladder cancer patients... High concordance between FGFR alterations detected with an FDA approved tissue CDx and urine cfDNA NGS assay demonstrates that the PredicineCARE urine cfDNA NGS assay may represent a novel, accurate, and non-invasive clinical application for molecular diagnostic testing to identify biomarkers in bladder cancer.
Next-generation sequencing
|
FGFR2 (Fibroblast growth factor receptor 2)
|
FGFR mutation
|
therascreen® FGFR RGQ RT-PCR Kit • PredicineCARE™
|
Balversa (erdafitinib)
over1year
NOVEL USE OF CTDNA AND UTDNA TO IDENTIFY MUSCLE-INVASIVE AND NON-ORGAN-CONFINED UPPER TRACT UROTHELIAL CARCINOMA (SUO 2022)
Prospective ctDNA and utDNA analysis using a targeted NGS panel is a feasible nonsurgical approach to prediction of muscle-invasive and non-organ-confined UTUC and has the potential for identification of upper tract urothelial cancer patients that may derive benefit from NAC.
Circulating tumor DNA
|
HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • FGFR3 (Fibroblast growth factor receptor 3)
|
PredicineCARE™
over1year
Pharmacodynamic and predictive biomarkers associated with response in cancer patients treated with TPST-1120: a first-in-class, small molecule antagonist of Peroxisome-Proliferator Activated Receptor-Alpha (SITC 2022)
Trial Registration TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers (NCT03829436). Patients with PR demonstrated gene expression changes that implicate immune activation and alleviation of immune suppression as potential biomarkers of clinical benefit. Increased frequencies of responding patients bearing PI3K pathway or IDH mutations may reveal populations likely to benefit from treatment with TPST-1120.
Late-breaking abstract • PK/PD data • Clinical • PD(L)-1 Biomarker • IO biomarker
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PTEN (Phosphatase and tensin homolog) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • TNFRSF1A (TNF Receptor Superfamily Member 1A) • PVR (PVR Cell Adhesion Molecule) • FCGR2A (Fc fragment of IgG receptor IIa) • APOE (Apolipoprotein E) • ITGAX (Integrin Subunit Alpha X) • NCF4 (Neutrophil Cytosolic Factor 4) • PPARA (Peroxisome Proliferator Activated Receptor Alpha)
|
PTEN mutation
|
PredicineCARE™ • nCounter® PanCancer Immune Profiling Panel
|
Opdivo (nivolumab) • TPST-1120
over1year
Exploratory subgroup and biomarker analyses of acelERA Breast Cancer: Phase II study of giredestrant (GDC-9545) vs physician’s choice of endocrine therapy for previously treated, estrogen receptor+, HER2– advanced breast cancer (SABCS 2022)
METHODS Patients were post- and pre- or peri-menopausal women, or men, with ER+, HER2– aBC who had progressed after 1–2 lines of systemic therapy in the advanced setting (≤1 targeted agent; ≤1 chemotherapy regimen; prior fulvestrant allowed). Overall, these data support continued investigation of giredestrant to advance and improve treatment outcomes in hormone receptor+ BC. Exploratory subgroup analyses
P2 data
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
|
PIK3CA mutation • ER mutation • ER Y537S • ER D538G • ESR1 mutation • ER Y537N
|
FoundationOne® Liquid CDx • PredicineCARE™
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fulvestrant • giredestrant (GDC-9545)
over1year
Disease features, genomic profiles and outcomes of younger vs. older Chinese hormone receptor positive (HR+), HER2 negative (HER2-) metastatic breast cancer (MBC) patients (SABCS 2022)
In this group of real- world HR+/HER2- MBC breast cancer patients, younger age was not associated with worse outcomes. While current guidelines recommend treatment decisions based on tumor biology rather than age, young HR+ breast cancer patients are more likely to receive chemotherapy. Our findings support the development of biomarker-driven treatment strategies for these patients.
Clinical
|
HER-2 (Human epidermal growth factor receptor 2) • FGFR1 (Fibroblast growth factor receptor 1) • CCND2 (Cyclin D2)
|
HR positive • HER-2 negative
|
PredicineCARE™
over1year
New P2 trial
|
MET (MET proto-oncogene, receptor tyrosine kinase)
|
MET amplification
|
PredicineCARE™
|
Tabrecta (capmatinib)
over1year
Predicine’s liquid biopsy Next-Generation Sequencing (NGS) assay is granted Breakthrough Device Designation by U.S. Food and Drug Administration (Predicine Press Release)
"Predicine, Inc...announced...that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation to the PredicineCARE cfDNA Assay, a Next-Generation Sequencing (NGS) assay for tumor mutation profiling in cfDNA isolated from liquid biopsy samples from cancer patients."
FDA event
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PredicineCARE™
over1year
Predicine expands to Europe with the recently launched CE-Marked cfDNA Assay PredicineCARE™ for genomic profiling in blood and urine (Predicine Press Release)
"Predicine, Inc...has launched its CE-marked PredicineCARE™ for genomic profiling in blood and urine. The PredicineCARE cell free DNA (cfDNA) assay is a targeted Next-Generation Sequencing (NGS) assay for the detection of single nucleotide variants (SNVs), insertions and deletions (Indels), DNA re-arrangements (fusions) and copy number variations (CNVs) in patients diagnosed with cancer."
Launch • European regulatory
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PredicineCARE™
almost2years
Identification of mutation patterns and circulating tumour DNA-derived prognostic markers in advanced breast cancer patients. (PubMed, J Transl Med)
P; This study revealed the molecular profiles of Chinese patients with ABC and the clinical validity of ctDNA-derived markers, including the ctDNA fraction and bTMB, for predicting treatment response, prognosis, and disease progression.
Journal • Tumor mutational burden • Circulating tumor DNA
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • FGFR1 (Fibroblast growth factor receptor 1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A)
|
HR positive • HER-2 amplification • FGFR1 amplification • CDKN2A deletion • ER mutation • CDKN2A mutation • ESR1 mutation • EGFR positive
|
PredicineCARE™
almost2years
Novel Use of ctDNA to Identify Locally Advanced and Metastatic Upper Tract Urothelial Carcinoma (AUA 2022)
The panel was 100% specific with no patients with pTis, pTa, pT1 and pN0 having detectable concordant ctDNA mutations. Conclusions : Prospective ctDNA analysis using a targeted NGS panel is a feasible nonsurgical approach to prediction of high-risk UTUC and has the potential for identification of upper tract urothelial cancer patients that may benefit from NAC.
Circulating tumor DNA
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HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • FGFR3 (Fibroblast growth factor receptor 3) • ARID1A (AT-rich interaction domain 1A)
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PredicineCARE™
2years
Novel use of ctDNA to identify locally advanced and metastatic upper tract urothelial carcinoma. (ASCO-GU 2022)
"Prospective ctDNA analysis using a targeted NGS panel is a feasible nonsurgical approach to prediction of high-risk UTUC and has the potential for identification of upper tract urothelial cancer patients that may benefit from NAC."
Circulating tumor DNA
|
HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • FGFR3 (Fibroblast growth factor receptor 3) • ARID1A (AT-rich interaction domain 1A)
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PredicineCARE™