High-Resolution NGS-Based Testing for Hereditary Breast and Ovarian Cancer Risk
The IVDNGS™ Breast Cancer Panel (BRCA1/2) is a specialized Next-Generation Sequencing (NGS)-based in vitro diagnostic test designed to detect mutations in the BRCA1 and BRCA2 genes. These genes are critically associated with hereditary breast and ovarian cancer syndrome (HBOC). The test enables early risk assessment, genetic counseling, and informed decision-making for patients and their families.
This panel provides high analytical sensitivity to detect single nucleotide variants (SNVs), insertions/deletions (indels), and splice-site mutations, covering all coding exons and intron-exon boundaries of BRCA1 and BRCA2.
Comprehensive sequencing of BRCA1 and BRCA2 genes
Detects SNVs, indels, and splice-site mutations
Suitable for germline testing using blood or saliva samples
Enables identification of hereditary cancer risk in both affected and at-risk individuals
Developed under ISO 13485 and IVD-compliant quality systems
Compatible with genetic counseling workflows
Risk assessment for hereditary breast and ovarian cancer
Family screening and cascade testing
Therapeutic decisions including suitability for PARP inhibitors
Surveillance strategies for high-risk individuals
Post-diagnosis treatment planning in breast and ovarian cancer patients
| Parameter | Description |
|---|---|
| Panel Name | IVDNGS™ Breast Cancer Panel (BRCA1/2) |
| Genes Covered | BRCA1, BRCA2 |
| Targeted Variants | SNVs, Indels, Splice-site mutations |
| Sample Types | Whole blood, Saliva, Buccal swab |
| DNA Input | ≥10 ng |
| Technology | Targeted Next-Generation Sequencing (NGS) |
| Clinical Use | Hereditary breast and ovarian cancer risk assessment |
| Turnaround Time | 7–10 working days |
| Intended Use | Germline testing for unaffected and affected individuals |
| Reporting | Clinically relevant variants with pathogenicity classification (ACMG guidelines) |
| Compliance | ISO 13485, IVD use |
| Applications | Risk screening, cascade testing, therapy guidance, and genetic counseling |
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