Caris MI Tumor Seek™

• Whole Exome Sequencing (DNA) – 22,000 genes
• Whole Transcriptome Sequencing (RNA) – 22,000 genes

Clinicians will receive a detailed and easy to interpret report that details the following:

• The biomarker tested for, the result with therapy associations ranked 1-3 by level of evidence⁽¹⁾.
• Important biomarker and associated therapy results with strength of evidence as defined by the FDA tiered biomarker reporting classification and/or biomarker association to the treatment (i.e., companion dx).
• Therapies with potential benefit.
• Therapies with potential lack of benefit.
• Clinical trial information, including Right-In-Time Clinical
• Trials relevant for the patient based on gender, age, tumour type and biomarker profile.

(1) Therapy associations are constantly updated based on industry guidelines and emerging clinical literature.

NOTE: Report information must be considered in conjunction with all other relevant information with respect to a given patient before determining the appropriate course of treatment.

Who can order this test from Everything Genetic? Healthcare providers

Turnaround time: 10-14 calendar days from receipt of sample in the US (13 days is the most frequent turnaround time reported).

Preferred specimen collection:

• Formalin Fixed Paraffin Embedded (FFPE) block (Preferred): One tumour-containing formalin fixed paraffin embedded block (FFPE) with a minimum of 20% tumour nuclei from most recent surgery or biopsy. Successive four (4) micron sections will be created from the block until sufficient material for the testing orders is obtained. For the molecular analysis, tumour cells will be excised by microdissection until a total area of at least 60 mm2 is obtained.
• Fixed tissue: FFPE block or 10 unstained slides with a minimum of 20% malignant origin for DNA and 10% malignant origin for RNA. Needle biopsy is also acceptable (4-6 cores).
• Unstained slides: 10 unstained, positively charged, unbaked slides from one single tumour containing formalin fixed paraffin embedded block; 4 micron sections – Tumour content: >20% tumour nuclei

Notes: Specimens with a smaller tumour area may require additional specimen to be submitted. If the tumour area per slide exceeds 25mm², fewer slides are needed for testing.

• Core Needle Biopsy: 4-6 biopsies with 18 guage needle preferred. 6-10 biopsies with 22 gauge needle accepted. (Preparation in 10% neutral buffered formalin.)
• Fine Needle Aspirate (FNA): 1 formalin fixed paraffin embedded block containing sufficient tumour (20% or more tumour nuclei). Please do NOT use non-formalin-based fixatives, including alcohol-based fixatives.
• Malignant Fluid Cell Block: 1 formalin fixed paraffin embedded block containing sufficient tumour (20% or more tumour nuclei). Please do NOT use non-formalin-based fixatives, including alcohol-based fixatives.
• Bone/Bone Metastasis: 1 formalin fixed paraffin embedded block of tumour (primary bone malignancy or metastasis to the bone) decalcified using EDTA based method(s) or non-decalcified specimen.

Please note: sufficient tumour (>20% tumour nuclei) must be present to be complete all analysis.

Delivery information: Test kits will be sent out to the pathology laboratory where the patient sample is held, by using a Royal Mail Tracked service, unless otherwise arranged.

Caris MI Tumor Seek™ is a Next-Generation Sequencing (NGS)-based tumour profiling service that includes Whole Exome Sequencing (WES) analysis of DNA for mutations, copy number alterations, insertions/deletions, genomic signatures (MSI, TMB, LOH), and Whole Transcriptome Sequencing analysis for RNA fusions and variant transcripts.

Using comprehensive tumour profiling of DNA and RNA with multiple technologies, Caris MI Tumor Seek™ reveals a more complete molecular blueprint to decode cancer and guide more precise and individualised treatment decisions.

Assay and technical information

All molecular profiling orders include next generation sequencing of all 22,000 genes.

Whole Exome Sequencing (WES) DNA

• 22,000 genes
• 800 x for clinical genes
• SNVs, indels, copy number alterations and karyotyping
• 250,000 evenly spaced genomic SNP
• Viruses
• Genomic signatures:
  • Loss of Heterozygosity (gLOH)
  • Microsatellite Instability (MSI)
  • Tumour Mutational Burden (TMB)
• Other:
  • HLA Genotype

Whole Transcriptome Sequencing (WTS) RNA

• 22,000 genes
• 60 million read count
• Gene fusions, variant transcripts and gene expression
• Novel translocation detection independent of intronic breakpoint

Testing methodologies are consistent with FDA Companion Dx and industry guidelines.

Validations and papers

View all validation documents and papers for this genetic test here >>