Specimen Preparation Instructions

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Collect Sufficient Specimen

All samples should be formalin-fixed
Sufficient tissue must be available to complete all analysis
Total surface area needed >50mm², 4μm thick
Tissue from the most recent tumour biopsy or recurrence is recommended (6-12 months old)

Fixed Specimen

Paraffin Block (Preferred)

Specimen Options:

One (5mm x 5mm) block
Four to six core needle biopsies (18- gauge preferred)
One block (> 20% tumour nuclei) of Fine Needle Aspirate or Malignant Fluid

Unstained Slides

Specimen Requirements:

44 slides
5mm x 5mm x 4μm tissue/slide. (For small biopsies (tissue area < 5 mm x 5 mm) please cut two sections per slide for at least one half of the slides to ensure sufficient material for molecular assays.)

Verify Tumour Content

Cancer Cell Density needed for NGS

Minimum 50ng DNA ( ≥ 20% tumour origin)

Tissue Inspection and Cell Enrichment

When possible, Caris Life Sciences^® will microdissect specimen with < 50% cancer cells to increase the Cancer Cell Density for higher quality testing. If the tissue on the slide has a large percent of tumour, the DNA can be obtained from a fewer number of slides.

Formalin Fixed Paraffin Embedded (FFPE) Samples

SPECIMEN TYPE	SPECIMEN REQUIREMENTS
Fixed Tissue	One (1) tumour-containing formalin fixed paraffin embedded block (FFPE) 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 50mm² is obtained.
Unstained Slides	Unstained, positively charged, unbaked slides from one single, tumour-containing formalin fixed paraffin embedded block; 4 micron sections MI Profile™ – 44 slides Note: At least a 5mm x 5mm section of tissue per slide is required. For small biopsies (tissue area < 5 mm x 5 mm) please cut two sections per slide for at least one half of the slides to ensure sufficient material for molecular assays.
Core Needle Biopsy	Four to six (4-6) biopsies formalin fixed paraffin embedded 18 gauge needle preferred
Fine Needle Aspirate (FNA)	One (1) formalin fixed paraffin embedded block containing sufficient tumour

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Created: February 28, 2017 - Modified: June 28, 2019