Sign in →

Test Code EGFRFF (FFPE), EGFRCS (Cytology Smear) EGFR Mutation Assay

Specimen Type

FFPE or
Cytology Smear

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
EGFR (Epidermal
Growth Factor Receptor)
gene, exons 3, 7, 15, 18, 19, 20, and 21.EGFR is a proto-oncogene
located on chromosome 7p12.
Mutations in the EGFR occur in 10-40% of
non-small cell lung cancers (NSCLC).

Preferred Volume

n/a

UCMC Collection Instructions

Formalin fixed tissue (paraffin block, unstained
slides). 
Sections should be at least 1cm2, and contain at least 40%
tumor
cells.

STAT Turnaround Time

n/a

Test Usage

Testing for EGFR mutations can aid in
treatment decisions for patients who are candidates for
TKI therapies.
EGFR mutations
have also been described in malignant
mesothelioma

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

79809

Synonyms

EGFR

DAY(S) AND TIME(S) PERFORMED

Monday -Friday, 9AM – 5PM

STAT DAY(S) AND TIME(S) PERFORMED

Not Available

CPT

81235

Method Name

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

Interpretive report will be
provided.