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    TEST:
    AVENIO ctDNA Surveillance Kit

    Company:
    Roche
    Type:
    Laboratory Developed Test
    Related tests:
    Details
    Evidence

    News

    2ms
    Preliminary results from LuCa-MERIT-1, a first-in-human Phase I trial evaluating the fixed antigen mRNA vaccine BNT116 + docetaxel in patients with advanced non-small cell lung cancer (AACR 2024)
    BNT116 + DTX shows encouraging antitumor activity, consistent induction of immune responses, a manageable safety profile, and no signs of additive toxicity. Updated safety and clinical activity data will be presented along with additional biomarker data.
    P1 data • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
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    CLDN6 (Claudin 6) • MAGEA4 (Melanoma antigen family A, 4) • PRAME (Preferentially Expressed Antigen In Melanoma)
    |
    AVENIO ctDNA Surveillance Kit
    |
    docetaxel • BNT116
    2ms
    Mutated TP53 prevalence in EGFR-mutated advanced non-small cell lung cancer patients with brain metastases (AACR 2024)
    Prevalence of TP53 mutations in plasma collected before osimertinib treatment initiation in advanced EGFR-mutated NSCLC was similar between patients with and without BM at baseline. Furthermore, there was no difference in the ctDNA profile between these two cohorts. Future experiments will clarify the impact of TP53 mutations in patients with or without BM.
    Clinical • Metastases
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    EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53)
    |
    TP53 mutation • EGFR mutation
    |
    AVENIO ctDNA Surveillance Kit
    |
    Tagrisso (osimertinib)
    over1year
    Biomarker Analysis from a Phase II Alternating Therapy with Osimertinib and Afatinib for EGFR-Mutated NSCLC (WJOG10818L) (IASLC-ACLC 2022)
    Alternating therapy with osimertinib and afatinib for treatment-naïve patients with EGFR-mutated advanced NSCLC demonstrated encouraging efficacy. The advantages of this therapy are prevention of acquired resistance via secondary EGFR mutations, including T790M and C797S, and a broadened efficacy against various compound EGFR mutations.
    P2 data
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • MET (MET proto-oncogene, receptor tyrosine kinase) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
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    EGFR mutation • HER-2 amplification • EGFR L858R • EGFR exon 19 deletion • MET amplification • EGFR T790M • EGFR C797S • ERBB3 mutation • ERBB3 amplification • EGFR E709G
    |
    AVENIO ctDNA Surveillance Kit
    |
    Tagrisso (osimertinib) • Gilotrif (afatinib)
    2years
    Longitudinal cell-free DNA analysis in phase I study evaluating afatinib in combination with osimertinib in patients who failed prior osimertinib treatment (AACR 2022)
    This signal seeking biomarker study using cfDNA to better understand the association of mutational status and the treatment efficacy of the combined treatment was feasible and informative despite the small-scale study, supporting the advantage of further implementation.
    Combination therapy • P1 data • Clinical
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    TP53 mutation • KRAS mutation • EGFR mutation • HER-2 amplification • EGFR L858R • MET amplification • EGFR T790M • EGFR C797S • EGFR L858R + EGFR T790M • EGFR G796S
    |
    AVENIO ctDNA Surveillance Kit
    |
    Tagrisso (osimertinib) • Gilotrif (afatinib)
    over2years
    Detection of minimal residual disease (MRD) in colorectal cancer (CRC) patients UICC stage II/III by ultra-deep sequencing of cfDNA from post-surgery plasma. (ASCO-GI 2022)
    Even in this small cohort of CRC UICC stage II/III patients, MRD detection in post-surgery plasma is the strongest predictor of shorter time to progression. Ultra-deep sequencing of cfDNA samples did not influence MRD detection on a patient-level. *for Research Use Only; not for use in diagnostic procedures.
    Clinical • Minimal residual disease
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    AVENIO Tumor Tissue Surveillance Kit • AVENIO ctDNA Surveillance Kit
    over2years
    [VIRTUAL] NAVIFY Mutation Profiler Applied to Annotation of Somatic Cancer Variants: Automated Identification of Actionable Targets and Variant Interactions in Cell-Free DNA from Colorectal Cancer (AMP 2021)
    Using NAVIFY Mutation Profiler for automated annotation, we found 17.6% of somatic variants in CRC ctDNA were of strong or potential clinical significance (Tier I or II). Using manual curation, we found only 7.9% of variants with any level of evidence in OncoKB. Furthermore, 19.6% of cases had at least 1 potentially actionable variant combination according to NAVIFY Mutation Profiler.
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
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    BRAF mutation
    |
    AVENIO ctDNA Surveillance Kit
    almost4years
    [VIRTUAL] Concordance between treatment-naive tissue and circulating tumour DNA (ctDNA) in late stage non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) (ESMO 2020)
    "Legal entity responsible for the study: Roche Sequencing Solutions, Inc. Funding: Roche Sequencing Solutions, Inc."
    KIT mutation
    |
    AVENIO Tumor Tissue Surveillance Kit • AVENIO ctDNA Surveillance Kit