SymGene Focus – NGS GYN Cancer Panel

Formalin-fixed, paraffin-embedded tissue blocks; fixed in 10% neutral-buffered formalin for at least 6 hours, and not more than 72 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.

NGS_GYN-gene panel is comprised of 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, BRAF, BRCA1, BRCA2, CTNNB1, ERBB2, FOXL2, KRAS, MAP2K1, MLH1, MLH2, MSH6, PIK3CA, PMS2, POLD1, POLE, PTEN, TP53.

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. Mutations in BRAC1/2 and MMR genes are particularly useful for treatment decision in ovarian cancers. Similarly, mutations in POLE and TP53 genes are important to determine the subtypes associated with different outcomes.

Clinical indication, copy of pathology report, and specimen source is required for the assay.

Room temperature or refrigerated. Ship in cooled container during summer months.

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.

2 years - raw data and DNA. 10 years FFPE

Only tissue that is clearly invasive carcinoma (established by histopathologic criteria) should be tested. Selection of tissue for the PCR assay should be performed by a pathologist. This test was developed and its performance characteristics determined by CellNetix Labs LLC. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. CellNetix is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.