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
 |
