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    Clinical Panels

    NovoFocus™ PARPi CDx 1.0

    Provide the method to identify patients who may benefit from PARPi therapy

    NovoFocus™ PARPi CDx 1.0 is a next-generation sequencing (NGS)-based companion diagnostic (CDx) assay for poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi) therapy in ovarian and breast cancers. BRCA1/2 mutations are highly relevant to ovarian and breast cancers. Mutations in homologous recombinant repair (HRR) genes cause homologous recombination deficiency (HRD).

    Mechanism of PARP Inhibition

    HRR Gene Mutation and PARPi Therapy

    PARP inhibitors approved by the U.S. Food and Drug Administration (FDA):

    Lynparza® (olaparib), Talzenna™ (talazoparib), Rubraca® (rucaparib) and Zejula® (niraparib) for deleterious or suspected deleterious BRCA1/2-mutated ovarian cancer and BRCA1/2 mutated, HER2-nagetive metastatic breast cancer patients.

    Zejula® (niraparib) for advanced ovarian cancer which is associated with homologous recombination deficiency, including loss of heterozygosity (LOH).

    Parameters

    NovoFocus™ PARPi CDx 1.0
    Cancer Type
    Breast Cancer Ovarian Cancer
    Sample Type
    FFPE Blood Plasma (Extracted DNA)
    Turnaround Time
    14 Calendar Days
    Novogene Quality Assurance
    Comprehensive Report

    NovoFocus™ PARPi CDx 1.0 interrogates 45 genes. It can detect genomic abnormalities (SNV, InDel, CNV and Fusion) and homologous recombination deficiency (HRD). Besides, it provides targeted therapy options and related hereditary cancer risk assessment.

    Reliable Performance

    Comprehensive analytical validation has been completed and the test includes rigorous quality control measures.

    Competitive Price

    With leading-edge sequencing solutions and superior process efficiency, Novogene offers highly competitive prices for all our service.

    Who Benefit from NovoFocus™ PARPi CDx 1.0?

    All breast cancer patients and ovarian cancer patients are highly recommended to have the test, especially for the following patients:

  • Breast cancer patients with HER2-negative tumors.
  • Breast cancer patients with triple-negative tumors.
  • Patients with platinum-sensitive or platinum-resistant ovarian cancer who have been treated with two or more lines of chemotherapy.
  •  

    Note: Prostate cancer or other cancer patients can be tested according to the physicians’ suggestion.

    Workflow

    Technical Specifications

    Sample Types
    Paired FFPE/Whole blood (gDNA) or FFPE alone
    Whole blood (cfDNA and gDNA)
    Detect Content
    45 genes (including BRCA1/2)
    45 genes (including BRCA1/2)
    Genetic Variation
    Somatic and germline mutations, HRD
    Somatic and germline mutations, HRD
    Sequencing Mean Depth
    ≥ 1400X
    ≥ 1600X
    Turnaround Time
    14 calendar days from sample receival to test report delivery
    14 calendar days from sample receival to test report delivery

    Data Interpretation

    Gene List

    Evidence Level NovoFocusTM PARPi CDx 1.0 (45 genes)
    NCCN guideline
    BRCA1, BRCA2
    From clinical trials of PARP inhibitors
    ATM, ATR, BARD1, BRIP1, CDK12, CHEK1, CHEK2, ERCC3, ABRAXAS1(FAM175A), FANCA, FANCL, FANCM, GEN1, HDAC2, MRE11, MLH3, MSH2, MSH6, NBN, PALB2, PMS2, PPM1D, PPP2R2A, PTEN, RAD50, RAD51B, RAD51C, RAD51D, RAD54L
    DNA damage repair pathway
    TP53
    NCCN guideline for genetic/Familial High-risk assessment: breast and ovarian cancer
    CDH1, EPCAM, MLH1, NF1, STK11
    NCCN guideline for genetic/Familiar High-risk assessment: colon cancer
    APC, MUTYH
    Other gene targets in breast cancer or ovarian cancer
    AR, ERBB2, ESR1, PIK3CA, TSC1, TSC2