GEM Cancer Panel™
Introducing the GEM Cancer Panel™, Ashion Analytics™ flagship clinical assay.
The GEM (Genomic-Enabled Medicine) Cancer Panel™ test provides treating physicians with vital interpreted information they need to understand changes to their patient’s genomic profile, and outline a therapeutic treatment plan best-suited for them. Conditions that may benefit from this approach include treatment of refractory, rare or aggressive cancers.
Ashion Analytics' laboratory, data analysis and interpretation approaches compare the sequence of genes in both tumor (somatic) and normal (germline) DNA.
Concomitant analysis of germline DNA allows for quick identification of true somatic alterations and maximizes the likelihood of identifying tumor-specific variations with an accuracy of >99%. This allows drug relationships to be based solely on tumor-specific DNA alterations, thus increasing treatment safety.
Our team has pioneered this approach since 2010. Recent studies of importance from TGen and others support analysis of both tumor and normal specimens.
The data from this research suggests that matched tumor-normal sequencing analyses are essential for precise identification and interpretation of somatic and germline alterations, having important implications for the diagnostic and therapeutic management of cancer patients.
Test Details
- Panel-based next-generation sequencing of both normal and tumor patient samples along with therapeutic interpretation.
- Deep capture of coding mutations across the annotated exome from 562 genes.
- Genes include: (i) known cancer drug targets, (ii) newly identified drug targets being developed against genes and molecular pathways known to play critical roles in cancer, (iii) genes known to be directly mutated in cancer and (iv) genes known to undergo structural variation in cancer.
- High sensitivity for detecting point mutations (single nucleotide variants, frameshifting insertions, frameshifting deletions, non- frameshifting insertions, non-frameshifting deletions).
- GEM Cancer Panel™ measures genome-wide copy number content (30kb resolution).
- GEM Cancer Panel™ can distinguish focal copy number changes from other structural variations (e.g., gains of entire chromosome arms).
- Compatible with Formalin-fixed paraffin embedded (FFPE), fresh frozen tissue and peripheral blood.
Key Technical Highlights
- Regions Analyzed: The 562 gene panel includes coding regions for 540 genes, and non-coding regions for an additional 22 genes that are known to be structurally rearranged or altered in cancer. Additional regions for the identification of specific structural variants are also included.
- Sequencing Method: Targeted enrichment followed by sequencing on a HiSeq 2500 (Illumina, Inc.).
- Analytics: Methods include analysis of single nucleotide variants, insertions/deletions, structural variants, focal and whole genome copy number.
- Assay Specificity: >99%
- Assay Reproducibility: >99%
- Coverage: 500x
- Turn-around Time: 10-14 days.
- Test Requirements: FFPE solid tumor and peripheral blood.
- Sample Types:
- Tumor:
- At least 25mm² solid tumor or;
- 3-5 core needle biopsies in one or more FFPE blocks or;
- Unstained slides: 10 from a single tumor, ≥ 40 microns total or;
- Fresh Frozen Tissue (contact for details)
- Blood
- 5ml in EDTA, less than 7 days old.
- Tumor:
- DNA Input Required: ≥ 150 ng.