Symgene Focus – NGS Breast Cancer Panel
NGS; Breast cancer NGS; Next Generation Sequencing for breast carcinoma; Breast tumor profiling; Invasive ductal breast cancer; Invasive lobular breast cancer
- Tech Only CPT
- Tech Pro CPT 81445, 88381, G0452
- PowerPath Code NGS001
- Schedule Monday, Thursday (Variable)
- Turn Around Time 7-10 days
- Disease State Breast Cancer, Metastatic Cancers
- Methodology Next Generation Sequencing
Organs
Specimen Requirements
Formalin-fixed, paraffin-embedded tissue blocks; fixed in 10% neutral-buffered formalin for at least 6 hours, and not more than 48 hours. Tissue should be prepared in sections between 4 and 6 microns thick.Cell blocks and cytospins made from FNA (fine needle aspirates). Cytopathology ThinPrep slides with morphologic correlation. EDTA decal specimens are accepted.
Diagnostic Utility
NGS_Breast-gene panel is comprised oncogenes and tumor suppressor genes with compelling clinical and biological evidences as biomarkers to predict responses to targeted therapies. In addition, genetic profiling of these genes is useful for accessing prognosis and guiding treatment of individuals with advanced cancer who have exhausted standard treatment options. This NGS panel is designed to detect small mutations, splicing mutations in/flanking all coding exons, and genomic amplification and homozygous loss for each gene in the panel. The genes in this panel include: AKT1, BRCA1, BRCA2, CDKN2A, ERBB2, ESR1, PIK3CA, PTEN.
Clinical Significance
Somatic mutations have been identified in cancer-related genes for both solid tumors and hematologic disorders. These mutations are biomarkers with diagnostic, therapeutic, and prognostic values. Next Generation Sequencing (NGS) technology is creating new paradigms for cancer patient management. Multiple genes and regions could be screened and evaluated simultaneously to determine the personalized tumor profile. This mutation profile is useful to predict the prognosis and to determine the treatment strategy for cancer patients, either at initial diagnosis or with refractory diseases.
Required Patient Info
Clinical indication, copy of pathology report, and specimen source is required for the assay.
Storage and Transportation
Room temperature or refrigerated. Ship in cooled container during summer months.
Cause for Rejection
Tissue not verified for the presence of tumor and specimens fixed in fixatives other than formalin are not acceptable. Samples <10% tumor burden will not be tested, as false negative results cannot be ruled out. Surgical pathology report should be included. Only specimens decalcified in EDTA will be accepted.
Retention
2 years - raw data and DNA. 10 years FFPE
Comments
Clinical indication, copy of pathology report, and specimen source is required for the assay.