Next Generation Sequencing

Precision medicine and treatment decisions based on the gene mutations driving each patient’s individual cancer journey has increasingly focused on comprehensive molecular profiling through next generation sequencing (NGS). CorePath offers both DNA and RNA expression in solid and hematopoietic malignancies with reliable sampling, exceptional sensitivity, and clinically relevant turnaround time.  

In addition to offering comprehensive NGS panels as noted below, we can further provide a non-invasive alternative for monitoring therapy and detection of patient relapse with cell-free DNA/RNA (cfDNA/cfRNA) liquid biopsy. CorePath NGS testing has been validated to provide: 

  • Over 400 DNA for solid tumor, over 300 genes for hematology, and over 1600 RNA NCCN Guideline supported genes
  • Results in less than 10 days in most instances
  • QNS/TNP rate of less than 0.5%
  • Hematology and Solid Tumor sensitivity of >1%*; read depth of 2,000-3,000x
  • Pan-Tumor Liquid Biopsy sensitivity of >0.1%**; read depth of 25,000-30,000x

*Hotspot sensitivity = >0.01%, Prior history available = .001%. **Tumor informed = .001%. 

Next Generation Sequencing Tests – Hematology Panels

  • Over 300 cfDNA and over 1600 cfRNA genes
  • TAT: 8–10 Days
  • Indications: All hematologic neoplasms including lymphoma multiple myeloma, acute lymphoblastic leukemia, acute myeloid leukemia, MDS, TTV, CMML, MPN, VEXAS syndrome, and EBV, HTLV1, chromosomal abnormalities, and gene amplifications, T- & B-cell clonality analysis, monitor therapeutic response and minimal residual disease (MRD).
  • Diagnostic | Therapeutic | Prognostic | Heterogeneity | Clinical Trial Matching
  • Sample Type: Peripheral blood, Plasma, CSF
  • Sample Requirements:
    • Peripheral Blood: 10 mL minimum EDTA or 30-50 ng/μl DNA in microfuge tube.
    • CSF: 7-10 mL, clear tubes.
  • Results Reported: DNA and RNA
  • Storage/Transport: Specimens should be received at CorePath within 72 hours from collection to ensure sample integrity and acceptable cell viability. Ship same day as drawn whenever possible. Peripheral blood and bone marrow should be shipped at room temperature. In hot weather, use cold pack for transport, making sure cold pack is not in direct contact with specimen. Body fluids and tissue should be shipped at 4°C.
  • Type of Service: Global

  • Over 300 cfDNA and over 1600 cfRNA genes
  • TAT: 8–10 Days
  • Indications: All hematologic neoplasms including lymphoma, classification and diagnosis of lymphoma, multiple myeloma, acute lymphoblastic leukemia, and acute myeloid leukemia, includes IgHv mutation status, chromosomal abnormalities, and gene amplifications, EBV, HTLV1, TTV, T- & B-cell clonality analysis
  • Diagnostic | Therapeutic | Prognostic | Heterogeneity | Clinical Trial Matching
  • Sample Type: Bone marrow, Peripheral blood, Fresh tissue
  • Sample Requirements:
    • Peripheral Blood: 5 mL EDTA Preferred. 5 mL Sodium Heparin Acceptable.
    • Bone Marrow Aspirate: 2 mL EDTA or 2 mL Sodium Heparin.
    • FFPE: Paraffin Block or Unstained Slides (1 H&E slide and 6-10 unstained slides, 5-7 microns of tissue fixed with 10% NBF fixative).
  • Results Reported: DNA and RNA
  • Storage/Transport: Specimens should be received at CorePath within 72 hours from collection to ensure sample integrity and acceptable cell viability. Ship same day as drawn whenever possible. Peripheral blood and bone marrow should be shipped at room temperature. In hot weather, use cold pack for transport, making sure cold pack is not in direct contact with specimen. Body fluids and tissue should be shipped at 4°C.
  • Type of Service: Global

  • Over 300 cfDNA and over 1600 cfRNA genes
  • TAT: 8–10 Days
  • Indications: All hematologic neoplasms including lymphoma, classification and diagnosis of lymphoma, multiple myeloma, acute lymphoblastic leukemia, and acute myeloid leukemia, includes IgHv mutation status, chromosomal abnormalities, and gene amplifications, BCMA expression, GPCR5D, SLAMF7, EBV, HTLV1, TTV, T- & B-cell clonality analysis.
  • Diagnostic | Therapeutic | Prognostic | Heterogeneity | Clinical Trial Matching
  • Sample Type: Bone marrow, Peripheral blood, Fresh tissue
  • Sample Requirements:
    • Peripheral Blood: 5 mL EDTA Preferred. 5 mL Sodium Heparin Acceptable.
    • Bone Marrow Aspirate: 2 mL EDTA or 2 mL Sodium Heparin.
    • FFPE: Paraffin Block or Unstained Slides (1 H&E slide and 6-10 unstained slides, 5-7 microns of tissue fixed with 10% NBF fixative)
  • Results Reported: DNA and RNA
  • Storage/Transport: Specimens should be received at CorePath within 72 hours from collection to ensure sample integrity and acceptable cell viability. Ship same day as drawn whenever possible. Peripheral blood and bone marrow should be shipped at room temperature. In hot weather, use cold pack for transport, making sure cold pack is not in direct contact with specimen. Body fluids and tissue should be shipped at 4°C.
  • Type of Service: Global

  • DNA Genes: > 300
  • TAT: 8–10 Days
  • Indications: All hematologic neoplasms including lymphoma MDS, CMML, AML, MPN (JAK2, CALR, MPL), MRD, multiple myeloma, and other hematologic diseases
  • Diagnostic | Therapeutic | Prognostic | Heterogeneity | Clinical Trial Matching
  • Sample Type: Bone marrow, Peripheral blood, Fresh tissue
  • Sample Requirements:
    • Peripheral Blood: 5 mL in EDTA Preferred. 5 mL Sodium Heparin Acceptable.
    • Bone Marrow Aspirate: 2 mL EDTA or 2 mL Sodium Heparin.
    • FFPE: Paraffin Block or Unstained Slides (1 H&E slide and 6-10 unstained slides, 5-7 microns of tissue fixed with 10% NBF fixative)
  • Results Reported: DNA
  • Storage/Transport: Specimens should be received at CorePath within 72 hours from collection to ensure sample integrity and acceptable cell viability. Ship same day as drawn whenever possible. Peripheral blood and bone marrow should be shipped at room temperature. In hot weather, use cold pack for transport, making sure cold pack is not in direct contact with specimen. Body fluids and tissue should be shipped at 4°C.
  • Type of Service: Global

Next Generation Sequencing Tests – Solid Tumor Panels

  • Over 300 cfDNA and over 1600 cfRNA genes
  • TAT: 8–10 Days
  • Indications: All solid tumors. Chromosomal abnormalities, gene amplifications, HRR Fusions: ALK, ROS1, RET, NTRK1/2/3, and more. BRAF, CIC, EWSR1, PD-L1, MET exon 14 skipping and various alternative splicing, MET, HER2, PIK3CA, PTEN, Gene amplifications, AKT1, RAS, HER2, MYC, EGFR, HPV, EBV, TTV, T- & B-cell clonality analysis, monitor therapeutic response
  • Monitoring | Therapeutic | Prognostic | Heterogeneity | Clinical Trial Matching
  • Sample Type: Peripheral blood, Plasma, CSF
  • Sample Requirements:
    • Peripheral Blood: 10 mL minimum EDTA or 30-50 ng/μl DNA in microfuge tube.
    • CSF: 7-10 mL, clear tubes.
  • Results Reported: DNA and RNA
  • Storage/Transport: Specimens should be received at CorePath within 72 hours from collection to ensure sample integrity and acceptable cell viability. Ship same day as drawn whenever possible. Peripheral blood and bone marrow should be shipped at room temperature. In hot weather, use cold pack for transport, making sure cold pack is not in direct contact with specimen. Body fluids and tissue should be shipped at 4°C.
  • Type of Service: Global

  • DNA/RNA Genes: 434 / >1600
  • TAT: 7 –10 Days
  • Indications: All solid tumors. Fusions: ALK, ROS1, RET, NTRK1/2/3, and more. BRAF, CIC, EWSR1, PD-L1, MET exon 14 skipping and various alternative splicing, MET, HER2, EGFR, Gene amplifications, PIK3CA, PTEN, AKT1, RAS, TMB, MSI, and HRD. Cancer of unknown primary (CUP). TTV, HPV, EBV, T- & B-cell clonality analysis.
  • Diagnostic | Therapeutic | Prognostic | Heterogeneity | Clinical Trial Matching
  • Sample Type: FFPE
  • Sample Requirements: 1 H&E slide and 6-8 unstained slides, 5-7 microns of tissue fixed with 10% NBF fixative.
  • Results Reported: DNA and RNA
  • Storage/Transport: Specimens should be received at CorePath within 72 hours from collection to ensure sample integrity and acceptable cell viability. Ship same day as drawn whenever possible. Peripheral blood and bone marrow should be shipped at room temperature. In hot weather, use cold pack for transport, making sure cold pack is not in direct contact with specimen. Body fluids and tissue should be shipped at 4°C.
  • Type of Service: Global

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