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    TEST:
    Signatera™

    Company:
    Natera
    Type:
    CE Marked
    Related tests:
    22h
    A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy (clinicaltrials.gov)
    P2, N=20, Recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Apr 2026 --> Dec 2027
    Trial primary completion date • Minimal residual disease • Circulating tumor DNA
    |
    Signatera™
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    Tevimbra (tislelizumab-jsgr) • Fruzaqla (fruquintinib)
    1d
    Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment (clinicaltrials.gov)
    P2, N=15, Suspended, M.D. Anderson Cancer Center | Recruiting --> Suspended
    Trial suspension • Circulating tumor DNA
    |
    Signatera™
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    AMB-05X
    6d
    ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab (clinicaltrials.gov)
    P4, N=90, Not yet recruiting, NYU Langone Health
    New P4 trial • Circulating tumor DNA
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    BRAF (B-raf proto-oncogene) • IFNA1 (Interferon Alpha 1)
    |
    Signatera™
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
    23d
    Two Publications Highlight Clinical Utility of Signatera™ in Anal and Rectal Cancers (Natera Press Release)
    "Natera...today announced two peer-reviewed publications highlighting the clinical utility of Signatera, its personalized, tumor-informed circulating tumor DNA (ctDNA) assay, in anal squamous cell carcinoma (ASCC) and locally advanced rectal cancer (LARC)."
    Clinical
    |
    Signatera™
    1m
    A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy (clinicaltrials.gov)
    P2, N=20, Recruiting, M.D. Anderson Cancer Center | Active, not recruiting --> Recruiting
    Enrollment open • Minimal residual disease • Circulating tumor DNA
    |
    Signatera™
    |
    Tevimbra (tislelizumab-jsgr) • Fruzaqla (fruquintinib)
    1m
    Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma (clinicaltrials.gov)
    P2, N=44, Recruiting, Diwakar Davar | Trial completion date: Mar 2030 --> Sep 2030 | Trial primary completion date: Mar 2028 --> Sep 2028
    Trial completion date • Trial primary completion date • Circulating tumor DNA • First-in-human
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    LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Signatera™
    |
    Kimmtrak (tebentafusp-tebn)
    1m
    Utility of Circulating Tumor DNA to Assess Tumor Response in Patients with Locally Advanced Rectal Cancer Undergoing Neoadjuvant Therapy. (PubMed, Cancers (Basel))
    ctDNA was a strong predictor of recurrence in rectal cancer, including in NOM settings. In NOM patients, ctDNA detected local recurrences, highlighting its potential to guide post-NAT surveillance and treatment.
    Journal • Circulating tumor DNA
    |
    Signatera™
    1m
    Tumor-informed circulating tumor DNA stratifies recurrence risk and survival in anal squamous cell carcinoma. (PubMed, Nat Commun)
    During surveillance, ctDNA re-emergence precedes clinical or radiographic relapse in every case. These findings support the consideration of ctDNA as a dynamic, treatment-responsive biomarker warranting prospective validation for risk-adapted surveillance and adjuvant therapy in ASCC.
    Journal • Circulating tumor DNA
    |
    Signatera™
    2ms
    Regorafenib (Reg) and Lorigerlimab (Lor), RELO Regimen, in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy [ReLOAD Trial] (clinicaltrials.gov)
    P2, N=16, Suspended, M.D. Anderson Cancer Center | Not yet recruiting --> Suspended
    Trial suspension
    |
    Signatera™
    |
    Stivarga (regorafenib) • lorigerlimab (MGD019)
    2ms
    Multi-Institutional Study Evaluating the Role of Early Circulating Tumor DNA Dynamics During Treatment With Immune Checkpoint Inhibitors in Patients With Advanced-Stage Melanoma. (PubMed, JCO Precis Oncol)
    We found that early ctDNA dynamics after only 3-4 weeks of ICI initiation in patients with advanced-stage melanoma appears to be a candidate strategy to predict overall treatment response, risk of progression, and long-term survival. Larger prospective studies are warranted to validate the utility of early ctDNA changes in treatment monitoring.
    Clinical • Journal • Checkpoint inhibition • Circulating tumor DNA
    |
    Signatera™
    2ms
    The clinical utility of molecular residual disease testing in early-stage breast cancer. (PubMed, Expert Rev Anticancer Ther)
    MRD testing in early-stage breast cancer theoretically confers a significant clinical benefit with adjuvant therapy and during patient surveillance. However, there are concerns with the potential for aggressive or prolonged treatment, not to mention the specific approach to managing patients who are ctDNA positive but remain asymptomatic.
    Journal
    |
    Signatera™
    2ms
    Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment (clinicaltrials.gov)
    P2, N=15, Recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Feb 2026 --> Feb 2028
    Trial primary completion date • Circulating tumor DNA
    |
    Signatera™
    |
    AMB-05X