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    TEST:
    Signatera™

    Company:
    Natera
    Type:
    CE Marked
    Related tests:
    6d
    Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Who Achieved Durable Response by Anti-HER2 Treatment (HER2 CR) (clinicaltrials.gov)
    P=N/A, N=50, Active, not recruiting, Nagoya City University | Enrolling by invitation --> Active, not recruiting
    Enrollment closed • Circulating tumor DNA
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    Signatera™
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    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki)
    16d
    Circulating tumor DNA monitoring in ovarian cancer patients receiving PARPi maintenance therapy: Can we further personalize treatment? (PubMed, Gynecol Oncol)
    ctDNA status on-PARPi was a stronger predictor of disease progression compared to CA-125 or BRCA/HR status. While additional analyses are warranted, our data suggest that ctDNA is a promising biomarker for therapeutic decision-making.
    Journal • BRCA Biomarker • PARP Biomarker • Circulating tumor DNA
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    BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
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    Signatera™
    24d
    Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer (clinicaltrials.gov)
    P1, N=25, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Oct 2026 --> Oct 2027 | Trial primary completion date: Oct 2025 --> Oct 2026
    Trial completion date • Trial primary completion date
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    Signatera™
    |
    capecitabine • oxaliplatin • leucovorin calcium • fluorouracil topical
    2ms
    Successful IMvigor011 Trial Achieves 41% Improvement in Overall Survival for Bladder Cancer Patients (Natera Press Release)
    "Natera, Inc...today announced results from the randomized, double-blind, phase 3 IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC). The findings demonstrate that Signatera can expand the adjuvant treatment window and guide the use of adjuvant atezolizumab (Tecentriq®) in MIBC, resulting in improved disease-free survival (DFS) and overall survival (OS). Results will be presented today during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress."
    New P3 trial
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    Signatera™
    1m
    MRD GATE RCC: Molecular Residual Disease (MRD) Guided Adjuvant ThErapy in Renal Cell Carcinoma (RCC) (clinicaltrials.gov)
    P2, N=100, Recruiting, University of Alabama at Birmingham | Trial completion date: Sep 2025 --> Sep 2028 | Trial primary completion date: Jul 2025 --> Jul 2027
    Trial completion date • Trial primary completion date
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    Signatera™
    |
    Keytruda (pembrolizumab)
    2ms
    Adjuvant nivolumab versus placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. (PubMed, Ann Oncol)
    Five-year results confirm durable DFS benefit and consistent safety profile for adjuvant nivolumab in high-risk MIUC. Post-hoc exploratory ctDNA assessment identified patients at highest risk of recurrence and may inform tailored adjuvant therapy strategies, pending further validation.
    Clinical • Journal • PD(L)-1 Biomarker • Circulating tumor DNA
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression
    |
    Signatera™
    |
    Opdivo (nivolumab) • cisplatin
    2ms
    RAIDEN: Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
    P1, N=18, Recruiting, Mayo Clinic | Trial completion date: Nov 2025 --> Nov 2028 | Trial primary completion date: Nov 2025 --> Nov 2026
    Trial completion date • Trial primary completion date • Tumor mutational burden
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    Signatera™
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    2ms
    SIGNAL-ER 101: Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer (clinicaltrials.gov)
    P2, N=725, Not yet recruiting, Natera, Inc.
    New P2 trial
    |
    Signatera™
    2ms
    Clinical utility of tumour-informed circulating tumour DNA in patients with testicular cancer. (PubMed, BJU Int)
    ctDNA status in the MRD window predicted survival outcomes after orchiectomy and RPLND. Undetectable MRD window ctDNA demonstrated high NPV relative to imaging studies in CS I disease. Further investigation is warranted.
    Journal • Circulating tumor DNA
    |
    Signatera™
    2ms
    ULTIMATE: ctDNA-Informed Management of Early-Stage Rectal Cancer (clinicaltrials.gov)
    P2, N=200, Not yet recruiting, University of California, Davis
    New P2 trial • Circulating tumor DNA
    |
    Signatera™
    2ms
    Signatera™ Surveillance Testing Identified 100% of Uterine Cancer Recurrences in Advance of Imaging, New Study Shows (Natera Press Release)
    "Natera, Inc...today announced the publication of a new study in the Journal of Clinical Oncology Precision Oncology (JCO PO), validating Signatera for recurrence monitoring and treatment response assessment in patients with early-stage uterine cancer."
    Clinical
    |
    Signatera™
    2ms
    Natera Announces Publication of Signatera™ Validation Study in Testicular Cancer (Natera Press Release)
    ''Natera, Inc...today announced the publication of a peer-reviewed manuscript in the Journal of Clinical Oncology – Precision Oncology (JCO PO). The paper features results from a multi-institutional study evaluating circulating tumor DNA (ctDNA) as a prognostic biomarker for patients with germ cell tumors (GCT), including testicular cancer.''
    Clinical
    |
    Signatera™