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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