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TEST:
Caris Assure™

Type:
Laboratory Developed Test
Related tests:
Evidence

News

23d
Caris life sciences showcases data demonstrating the clinical value of clonal hematopoiesis identification and subtraction in liquid biopsy to improve the accuracy of treatment recommendations (Caris Life Sciences Press Release)
"Caris Life Sciences®...today announced the presentation of data highlighting the clinical value of subtracting clonal hematopoiesis (CH) mutations from liquid biopsy profiling results to avoid incorrect treatment recommendations. Caris generated the findings, in collaboration with leading cancer centers, including those within the Caris Precision Oncology Alliance™ (Caris POA), and presented the data on November 23, 2024, at the International Society for Liquid Biopsy (ISLB) 6th Annual Congress. The study’s results demonstrate the power of the Caris Assure™ assay to identify somatic tumor, incidental CH and incidental germline variants by sequencing both the plasma and buffy coat in a single whole exome and whole transcriptome next-generation sequencing assay."
Clinical data
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Caris Assure™
1m
Whole exome tumor molecular profiling from cerebrospinal fluid (CSF): preliminary results of a pilot study (SNO 2024)
These preliminary results suggest that CSF liquid biopsy may be useful for identifying mutations in primary and metastatic brain tumors. Serial sampling is feasible, and may disclose changes in diagnostic and/or driver mutations over time, with important therapeutic and diagnostic implications. Many mutations were found in CSF alone.
Clinical • BRCA Biomarker • IO biomarker
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PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • BCL2 (B-cell CLL/lymphoma 2) • NF1 (Neurofibromin 1) • MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • ATRX (ATRX Chromatin Remodeler) • BRCA (Breast cancer early onset) • PIM1 (Pim-1 Proto-Oncogene)
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PIK3CA mutation • IDH1 mutation • PTEN mutation • NF1 mutation • BRCA mutation
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Caris Assure™
1m
Whole exome tumor molecular profiling from cerebrospinal fluid (CSF): preliminary results of a pilot study (SNO 2024)
These preliminary results suggest that CSF liquid biopsy may be useful for identifying mutations in primary and metastatic brain tumors. Serial sampling is feasible, and may disclose changes in diagnostic and/or driver mutations over time, with important therapeutic and diagnostic implications. Many mutations were found in CSF alone.
Clinical • BRCA Biomarker • IO biomarker
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PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • BCL2 (B-cell CLL/lymphoma 2) • NF1 (Neurofibromin 1) • MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • ATRX (ATRX Chromatin Remodeler) • BRCA (Breast cancer early onset) • PIM1 (Pim-1 Proto-Oncogene)
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PIK3CA mutation • IDH1 mutation • PTEN mutation • NF1 mutation • BRCA mutation
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Caris Assure™
3ms
Treating the Tumor, Not the False Positives: Simultaneous Blood-based Molecular Profiling and Assessment of Clonal Hematopoiesis with Caris Assure (AMP 2024)
Jaclyn Hechtman will explore the utility of whole blood biopsy for profiling solid tumors, with a focus on the critical distinction between clonal hematopoiesis (CH) and tumor-derived mutations. By analyzing both plasma and Buffy coat, Caris Assure enables clinicians to more accurately identify tumor alterations, ensuring precise diagnosis and targeted treatment to improve patient outcomes.
Caris Assure™
9ms
Caris Life Sciences to showcase research highlighting the clinical value of comprehensive molecular profiling at the American Association for Cancer Research Annual Meeting (Caris Life Sciences Press Release)
"Caris Life Sciences® (Caris)...announced that the company and collaborators within the Caris Precision Oncology Alliance™ (POA) will collectively present 10 studies across eight tumor types at the 2024 American Association for Cancer Research (AACR) Annual Meeting on April 5-10, 2024, in San Diego, CA, at Booth Number 1105."
Clinical data
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Caris Assure™
10ms
AI enabled whole exome & transcriptome liquid biopsy addressing MCED, MRD, and therapy selection on a single platform (AACR 2024)
"Lastly, for therapy selection, detection of driver mutations where blood was collected within 30 days of matched tissue demonstrated high concordance with a PPA of 93.8% and PPV of 96.8%. CHIP correction proved to be essential as ~35% percent of patients had CHIP mutations, including KRAS, BRAF, ATM, BRCA1/2, findings that could lead to improper therapy selection.Herein, we demonstrate for the first time a single liquid biopsy assay that addresses the entire continuum of care in clinical oncology with optimal diagnostic, prognostic, and predictive utility for patients and physicians."
Liquid biopsy
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability)
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Caris Assure™
over1year
Validation of a whole exome/whole transcriptome liquid biopsy assay with correction for clonal hematopoiesis. (ASCO 2023)
The novel Caris Assure liquid biopsy platform demonstrates high sensitivity and specificity for somatic variants, while mitigating against FPs from CH, and identifying incidental germline pathogenic alterations.
Liquid biopsy • Biopsy
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Caris Assure™
2years
IMAGENE trial: multicenter, proof-of-concept, phase II study evaluating the efficacy and safety of combination therapy of niraparib with PD-1 inhibitor in solid cancer patients with homologous recombination repair genes mutation. (PubMed, BMC Cancer)
Furthermore, through translational research, our trial will shed light on which patients would benefit from the targeted combination therapy for patients with HRR gene-mutated tumor even after the failure of ICIs. The IMAGENE trial: jRCT, Clinical trial no.: jRCT2051210120, Registered date: November 9, 2021.
Combination therapy • Journal • P2 data • Tumor mutational burden • PD(L)-1 Biomarker • PARP Biomarker • IO biomarker
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TMB (Tumor Mutational Burden) • HRD (Homologous Recombination Deficiency)
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Caris Assure™
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Zejula (niraparib)
over2years
Caris Life Sciences introduces the Caris Assure™ liquid biopsy assay at ASCO 2022 (Caris Life Sciences Press Release)
"Caris Life Sciences®...introduced its Caris Assure™ liquid biopsy assay at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Booth #22081)...In an initial performance validation study of this first-of-its-kind whole exome, whole transcriptome (22,000 gene) blood assay, Caris Assure demonstrated more than 95 percent sensitivity for variant frequencies greater than 0.5 percent, while maintaining greater than 99.99 percent specificity."
Clinical
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Caris Assure™