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Test Code KRASO K-RAS Mutation Assay

Specimen Type

Block, paraffin embedded tissue or frozen sections

Container/Tube

Block or slides

Offsite Collection Instructions

Slides/blocks labeled with two patient identifiers and a
surgical pathology ID.

Turnaround Time

8-10 business days

Test Includes

This is no longer a Molecular Diagnostics standalone test!
 

This is a next-generation sequencing assay for detection of
somatic mutations located within mutational hotspot regions of
the
KRAS gene,
exons 2, 3 and
4.

Preferred Volume

n/a

UCMC Collection Instructions

Formalin fixed tissue (paraffin block, unstained slides).

Test Usage

KRAS
mutations frequently found in
neoplasms include those at exon 2 (codons 12 and 13) and exon 3
(codon 61). Mutations in KRAS codons 12
and 13 have been associated with lack of response to EGFR-targeted therapies in
both CRC
(colorectal cancer) and NSCLC (non-small-cell lung cancer)
patients.

Critical Results

None

Test Limitations

  • This test will not detect mutations in areas outside the
    targeted genomic regions.
  • Copy number alterations and translocations will not be
    detected.
  • This test is not intended to detect minimal residual
    disease.
  • Assay sensitivity is 5% mutant allele frequency, thus
    false-negative results may occur when there is a lower mutant
    allele burden.
  • Variants present at oligonucleotide binding sites may
    negatively interfere with hybridization (as with any PCR-based assay),
    potentially resulting in allelic
    under-sampling or drop-out.

Additional Information

Reporting: Mutations with known or possible pathogenic or
clinical significance are reported. Variants of unknown
significance are reported as such.

Fee Code

79812

Synonyms

KRAS;
K-RAS;
k-RAS

DAY(S) AND TIME(S) PERFORMED

Monday -Friday, 9AM – 5PM

STAT DAY(S) AND TIME(S) PERFORMED

Not Available

CPT

81275

Method Name

KRAS gene is
part of the OncoScreen
ST2.0 NGS
panel. The OncoScreen procedure
is performed and data for KRAS gene only
is analyzed.
 

The OncoScreen test is based on the Ion AmpliSeq Cancer
Hotspot
Panel (IACHP)
v2 (Life Technologies).
After DNA is
isolated and its quality and
quantity determined, a single multiplexed PCR is performed using a
single reaction containing
the 207 Ion AmpliSeq Cancer Hotspot primer pairs. It is then
cleaned up using Ampure XP beads and a library is constructed
using
KAPA
HTP
Library Preparation Kit and Illumina compatible adapters.
Through
the library construction, adapter oligonucleotides containing
unique patient-specific “barcode” indexes and P5/P7
sequences are ligated onto the amplicon PCR products to make an
Illumina compatible
sequencing library.All DNA samples for a
given run are processed in duplicate and in parallel, and then
following a library quantitation, samples with different
bar-code
sequences are pooled and sequenced in a 2 × 152 bp MiSeq
run.

Reference Values

Interpretative report will be provided.