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TEST:
OncoScreen Plus®

Type:
CE Marked
Related tests:
Evidence

News

over1year
Somatic mutations in four novel genes contribute to homologous recombination deficiency in breast cancer: a real-world clinical tumor sequencing study. (PubMed, J Pathol Clin Res)
Furthermore, functional experiments demonstrated that silencing CARD11 and GATA2 impairs HR repair efficiency and enhances the sensitivity of tumor cells to olaparib treatment. In summary, in the absence of mutations in the HR genes, the sensitivity of tumor cells to PARP inhibitors and platinum-based chemotherapy may be enhanced in a subset of breast cancer patients with LNGC somatic mutations.
Real-world evidence • Journal • PARP Biomarker • BRCA Biomarker • Real-world
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • LRP1B (LDL Receptor Related Protein 1B) • CARD11 (Caspase Recruitment Domain Family Member 11) • NOTCH3 (Notch Receptor 3) • GATA2 (GATA Binding Protein 2)
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BRCA2 mutation • BRCA1 mutation • HRD • High HRD score
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OncoScreen Plus®
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Lynparza (olaparib)
2years
Capivasertib (C) + fulvestrant (F) for patients (pts) with aromatase inhibitor (AI)-resistant HR+/HER2– advanced breast cancer (ABC): Phase III CAPItello-291 trial Chinese cohort (ESMO Asia 2023)
The most frequent AEs with C + F were diarrhoea (60.6% vs 11.3% P + F) and hyperglycaemia (57.7% vs 17.7%); the most frequent grade ≥3 AEs were rash maculopapular (8.5% vs 0%), rash and diarrhoea (both 7.0% vs 0%); grade ≥3 hyperglycaemia was 1.4% vs 0%. AEs leading to C/F discontinuation were reported in 11.3% for C + F vs 3.2% for P + F. Conclusions Similar to the Global population, the benefit–risk profile of C + F in the Chinese cohort appears favourable; no new safety concerns with C + F were identified.
Late-breaking abstract • P3 data • Clinical • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
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OncoScreen Plus®
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fulvestrant • Truqap (capivasertib)
over2years
Targetable gene fusions and other alterations in central nervous system tumors assessed by RNA and DNA-based next-generation sequencing (ESMO 2023)
Conclusions The combination of RNA- and DNA-based NGS provides information about molecular alterations for the management of patients with CNS tumors. Those with actionable gene fusions or other alterations may benefit from target therapy, especially in the setting of limited choice of treatments.
Next-generation sequencing
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BRAF (B-raf proto-oncogene) • FGFR1 (Fibroblast growth factor receptor 1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • KIAA1549 • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase) • TACC1 (Transforming Acidic Coiled-Coil Containing Protein 1) • PTPRZ1 (Protein Tyrosine Phosphatase Receptor Type Z1) • RELA (RELA Proto-Oncogene) • ZFTA (Zinc Finger Translocation Associated)
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CDKN2A deletion • CDKN2A mutation • KIAA1549-BRAF fusion • FGFR1 fusion • MET fusion • SETD2 mutation
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OncoScreen Plus®
over2years
Burning Rock's precision oncology diagnostics product supports advancement in late-stage breast cancer treatment, with results published in the New England Journal of Medicine (Burning Rock Dx Press Release)
"Burning Rock Biotech Limited...is pleased to announce that our flagship comprehensive genomic profiling (CGP) product, OncoScreen Plus, was featured in a phase 3 multi-regional clinical trial (MRCT), along with FoundationOneCDx, in support of advancement in breast cancer treatment...In the study, Burning Rock's flagship comprehensive genomic profiling (CGP) product, OncoScreen Plus, was used to determine activating mutations in PIK3CA and AKT1 and inactivating alterations in PTEN genes for patients enrolled in China."
P3 data
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FoundationOne® CDx • OncoScreen Plus®
over2years
Association of tumor mutational burden (TMB) and clinical outcomes with tislelizumab versus chemotherapy in esophageal cell carcinoma (ESCC) from RATIONALE-302 (AACR 2023)
P3 | "TMB status may play a role in predicting clinical outcomes in pts with advanced ESCC treated with TIS versus ICC, especially when a higher TMB cutoff is chosen. These findings need further prospective validation.Table. Clinical outcomes by TMB status (cutoff 10 mut/Mb)TMB statusTMB-HTMB-LTreatmentTISICCTISICCn (% in TMB BEP, N=209)27 (12.9)31 (14.8)78 (37.3)73 (34.9)ORR, % (95% CI)33.3 (16.5, 54.0)6.5 (0.8, 21.4)16.7 (9.2, 26.8)17.8 (9.8, 28.5)Median PFS, months (95% CI)2.4 (1.4, 5.5)2.3 (1.3, 2.9)1.4 (1.3, 2.7)2.7 (1.5, 3.3)PFS HR (95% CI)0.52 (0.28, 0.97)1.06 (0.73, 1.53)Interaction p-value0.0537Median OS, months (95% CI)6.1 (4.2, 18.6)4.7 (3.4, 7.0)8.6 (4.6, 11.8)7.0 (4.6, 8.6)OS HR (95% CI)0.58 (0.32, 1.04)0.72 (0.50, 1.03)Interaction p-value0.5374TMB-adjusted OS HR (95% CI)0.68 (0.5, 0.92)BEP, biomarker evaluable population; CI, confidence interval; HR, hazard ratio; ICC, investigator chosen chemotherapy; OS, overall survival; PFS, progression-free survival;..."
Clinical data • Clinical
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TMB (Tumor Mutational Burden)
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TMB-H • TMB-L
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OncoScreen Plus®
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Tevimbra (tislelizumab-jsgr)
over2years
Longitudinal ctDNA levels and clinical outcomes of first-line (1L) tislelizumab (TIS) + chemotherapy (chemo) treatment for advanced non-small cell lung cancer (NSCLC) in the RATIONALE-304 and 307 studies (AACR 2023)
FR ctDNA level is decreased from BL, and seems to correlate with clinical outcomes of 1L TIS in combination with chemotherapy in NSCLC; ctDNA has potential to be a surrogate biomarker for efficacy. This requires further prospective validation.Table.Analysis summary of ctDNA and PFS/OS by visitBaseline (BL)First response (FR)Study RATIONALE-304RATIONALE-307RATIONALE-304RATIONALE-307ctDNA UDDUDDUDDUDDn19578723284322mPFS, mo (95% CI)a9.23(5.75, 9.89)9.69(7.33, 14.52)NR(4.93, NR)9.76(7.52, 14.55)17.31(9.89, NR)9.20(3.71, 11.99)20.01(9.82, NR)9.56(7.39, 13.9)PFS HR (95% CI), UD/D1.14 (0.61, 2.21)0.40 (0.09, 1.73)0.16 (0.05, 0.5)0.54 (0.24, 1.21)PFS P-valueb 0.64210.22050.00190.1322mOS, mo (95% CI)NR(9.72, NR)NR(14,23, NR)NR(NR, NR)NR(16.89, NR)NR(NR, NR)18.78(9.92, NR)NR(NR, NR)NR(12.85, NR)OS HR (95% CI), UD/D1.04 (0.48, 2.25)NE0.16 (0.04, 0.69)0.48 (0.15, 1.51)OS P-valueb0.9254NE0.01470.2079aPrimary endpoint assessed by IRC; bP-values are reported for descriptive purposes only in this exploratory study.
Late-breaking abstract • Clinical data • Clinical • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA • Metastases
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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OncoScreen Plus®
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Tevimbra (tislelizumab-jsgr)
over2years
Integrative immune-genomic comparison of canonical Ewing sarcoma with Ewing-like mimics identifies potential targets for personalized therapies (AACR 2023)
Our study shows that NGS could efficiently facilitate the definitive diagnosis of ES and its mimics. We also revealed a diverse immune-genomic landscape of these SRCS, indicative of potential therapeutic opportunities targeting HRD and immune check-point in specific subtypes of these sarcoma entities.
PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • HRD (Homologous Recombination Deficiency) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • JAK2 (Janus kinase 2) • PD-1 (Programmed cell death 1) • MTAP (Methylthioadenosine Phosphorylase) • PTCH1 (Patched 1) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • EWSR1 (EWS RNA Binding Protein 1) • FLI1 (Fli-1 Proto-Oncogene ETS Transcription Factor)
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PD-L1 expression • TP53 mutation • HRD • ALK fusion • EWSR1-FLI1 fusion
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OncoScreen Plus®
over2years
Targetable oncogenic fusions and other alterations in bone and soft-tissue tumors assessed by RNA and DNA-based next-generation sequencing in real-world experience (AACR 2023)
The combination of RNA and DNA-based NGS techniques brings relevant information about tumor molecular alterations into the precision management of patients with bone and soft-tissue tumors. Those with tumors harboring targetable gene fusions and other alterations may benefit from target therapy, especially in the case of limited or exhausted standard therapy.
Real-world evidence • Clinical • Next-generation sequencing • Real-world
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NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • FGFR1 (Fibroblast growth factor receptor 1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MDM2 (E3 ubiquitin protein ligase) • ETV6 (ETS Variant Transcription Factor 6) • CDK4 (Cyclin-dependent kinase 4) • EWSR1 (EWS RNA Binding Protein 1) • FLI1 (Fli-1 Proto-Oncogene ETS Transcription Factor) • NTRK (Neurotrophic receptor tyrosine kinase) • DDIT3 (DNA-damage-inducible transcript 3) • PLAG1 (PLAG1 Zinc Finger)
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NTRK3 fusion • ALK fusion • MDM2 amplification • CDKN2A deletion • FGFR fusion • CDK4 amplification • FGFR1 fusion
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OncoScreen Plus®
almost3years
Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects (clinicaltrials.gov)
P2; Trial completion date: Apr 2023 --> Apr 2025 | Trial primary completion date: Oct 2022 --> Oct 2023
Combination therapy • Trial completion date • Trial primary completion date • Metastases
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PD-L1 expression
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OncoScreen Plus®
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cisplatin • gemcitabine • Loqtorzi (toripalimab-tpzi)
over3years
Genome instability index used for the optimization of molecular classification of endometrial carcinoma (ESMO 2022)
Further analysis showed that patients in GI-high group had higher tumor grade, aneuploidy and lower T cell infiltrations. Conclusions The one-stop method of GI index combined with POLE mutation offers more accurate and stable disease risk stratification and demonstrates the potential for guiding therapy for EC patients.
MSi-H Biomarker
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TP53 (Tumor protein P53) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon)
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TP53 mutation • MSI-H/dMMR • TP53 wild-type • POLE mutation
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OncoScreen Plus®
over3years
The Increase of Blood Intratumor Heterogeneity Is Associated with Unfavorable Outcomes of ICIs Plus Chemotherapy in NSCLC (IASLC-WCLC 2022)
The present study is the first to report that the increase of bITH is associated with unfavorable outcomes of ICIs plus chemotherapy in advanced NSCLC patients.
Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • LRP1B (LDL Receptor Related Protein 1B)
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PD-L1 expression • LRP1B mutation
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OncoScreen Plus®
over3years
The Increase of Blood Intratumor Heterogeneity is Associated with Unfavorable Outcomes of ICIs Plus Chemotherapy in NSCLC (IASLC-WCLC 2022)
The present study is the first to report that the increase of bITH is associated with unfavorable outcomes of ICIs plus chemotherapy in advanced NSCLC patients.
Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • LRP1B (LDL Receptor Related Protein 1B)
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PD-L1 expression • LRP1B mutation
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OncoScreen Plus®