^
    8ms
    CodeBreak 300: Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation (clinicaltrials.gov)
    P3, N=160, Active, not recruiting, Amgen | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Mar 2025 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    therascreen® KRAS RGQ PCR Kit
    |
    Vectibix (panitumumab) • Lumakras (sotorasib) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)
    11ms
    CodeBreak 300: Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation (clinicaltrials.gov)
    P3, N=160, Active, not recruiting, Amgen | Trial completion date: Mar 2025 --> Jun 2025
    Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    therascreen® KRAS RGQ PCR Kit
    |
    Vectibix (panitumumab) • Lumakras (sotorasib) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)
    1year
    Clinical Study Testing DNA Extracted From Tumour Tissue Biopsy Samples, Using the Therascreen® KRAS RGQ PCR Kit (clinicaltrials.gov)
    P=N/A; Active, not recruiting --> Completed
    Trial completion • Biopsy
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation
    |
    therascreen® KRAS RGQ PCR Kit
    1year
    Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit (clinicaltrials.gov)
    P=N/A; Active, not recruiting --> Completed
    Trial completion • Biopsy
    |
    therascreen® KRAS RGQ PCR Kit
    almost2years
    KRAS and BRAF Mutation Rates and Survival Outcomes in Colorectal Cancer in an Ethnically Diverse Patient Cohort. (PubMed)
    The similarity in KRAS mutation rates across races raises the possibility that the differences in KRAS mutation rates reported from various countries may either not be statistically significant or may be due to environmental and/or laboratory factors rather than underlying racial genetic differences. In contrast, we verified that BRAF mutation rates differ significantly between races, suggesting racial genetic differences may be responsible for the discrepant BRAF mutation rates reported from different countries.
    Journal
    |
    therascreen® KRAS RGQ PCR Kit
    2years
    Characteristics and prognostic analysis of patients with detected KRAS mutations in resected lung adenocarcinomas by peptide nucleic acid-locked nucleic acid polymerase chain reaction (PNA-LNA PCR) clamp method. (PubMed, Transl Lung Cancer Res)
    "Recently, sotorasib was developed as a molecular targeted drug for KRAS mutations...By the PNA-LNA PCR clamp method, G12C mutation of surgical specimens was detected successfully. The PNA-LNA PCR clamp method is expected to be applied to the detection of druggable G12C mutations."
    Journal
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • KRAS mutation • KRAS G12D • KRAS G12V • ALK mutation • KRAS G12A • KRAS G12 • KRAS G12S
    |
    therascreen® KRAS RGQ PCR Kit
    |
    Lumakras (sotorasib)
    over2years
    CodeBreak 300: Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation (clinicaltrials.gov)
    P3; Trial primary completion date: Jun 2023 --> Mar 2025
    Trial primary completion date • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    therascreen® KRAS RGQ PCR Kit
    |
    Vectibix (panitumumab) • Lumakras (sotorasib) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)
    over2years
    CodeBreak 300: Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation (clinicaltrials.gov)
    P3, N=160, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    therascreen® KRAS RGQ PCR Kit
    |
    Vectibix (panitumumab) • Lumakras (sotorasib) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)
    over2years
    CodeBreak 300: Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation (clinicaltrials.gov)
    P3, N=153, Recruiting, Amgen | Trial completion date: Mar 2024 --> Feb 2025
    Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    therascreen® KRAS RGQ PCR Kit
    |
    Vectibix (panitumumab) • Lumakras (sotorasib) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)
    almost3years
    QIAGEN receives FDA approval for companion diagnostic to Mirati Therapeutics’ KRAZATI in non-small cell lung cancer (Qiagen)
    "QIAGEN...has announced the U.S. Food and Drug Administration (FDA) approval of its therascreen® KRAS RGQ PCR kit (therascreen KRAS kit) as a companion diagnostic test to Mirati Therapeutic’s drug KRAZATI® (adagrasib) for non-small cell lung cancer (NSCLC)...The tissue based KRAS companion diagnostic assay, which QIAGEN developed specifically to identify patients with NSCLC that have a KRAS G12C mutation, is instrumental in determining who may benefit from treatment with KRAZATI....With the new approval of therascreen KRAS for NSCLC, QIAGEN has eleven PCR based companion diagnostic indications that are FDA approved – the broadest portfolio of IVD approved PCR based companion diagnostics on the market."
    FDA event
    |
    therascreen® KRAS RGQ PCR Kit
    |
    Krazati (adagrasib)
    over3years
    Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit (clinicaltrials.gov)
    P=N/A; N=309; Active, not recruiting; Sponsor:QIAGEN Gaithersburg, Inc
    New trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    therascreen® KRAS RGQ PCR Kit
    over3years
    Clinical Study Testing DNA Extracted From Tumour Tissue Biopsy Samples, Using the Therascreen® KRAS RGQ PCR Kit (clinicaltrials.gov)
    P=N/A; N=495; Active, not recruiting; Sponsor:QIAGEN Gaithersburg, Inc
    New trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    therascreen® KRAS RGQ PCR Kit