Inpatient and Outpatient Orderable

EGFR Mutation Analysis

Synonyms

  • EGFR MUTATION ANALYSIS
  • LAB14277

Cerner Name

HLX EGFR Mutation Analysis

Clinical Info

ASSAY
DESCRIPTION: The
epidermal growth factor receptor (EGFR) signaling pathway is frequently
activated in human cancers including non-small cell lung adenocarcinoma (NSCLC)
and colorectal carcinoma (CRC). Mutations in EGFR biomarker have
diagnostic and prognostic value and determine the choice of treatment. This qualitative
assay, performed on the Biocartis Idylla™ System using
exclusivelly FFPE samples (Slides),  detects 51 EGFR mutations: Point
mutations in Exon 18 (G719A/C/S), 36 deletions in exon 19, Point mutations in
Exon 20 (T790M, S768I), 5 insertions in exon 20 and point mutations in exon 21
(L858R, L861Q) of the EGFR oncogene.
LIMITATIONS: This assay is qualitative and is
not intended to detect minimal residual diseas. The assay detects G719A, G719C
and G719S mutations but does not distinguish between each variant. Any of the 3
mutations will be reported as G719A/C/S. The assay relies on primers designed
to detect specific deletions in Exon 19, and insertions in Exon 20. While most
are covered by the assay, some, not covered by the primers, might not be
detected. Mutations present below the limit of detection of the assay (5%)
might not be detected. 

Specimen Sources

Abdomen/Peritoneum Abscess Adenoids Adenoids Adrenal, Left Adrenal, Right Alopecia Amputation Anus Appendix Axilla, Left Axilla, Right Bile Duct Bladder Bone Show more...

Specimen Types

Tissue

Container

FFPE-Slides

Collection Instructions

Specimen Volume

4 ubstained 5- μm FFPE slides (each with an area of 50-600 mm²) are required. If the tumor content is less than 10%, Please submit an additional H&E slide for macrodissection

Transport Instructions

Room Temperature

Specimen Stability

Methodology

Qualitative Real-Time PCR performed on the Idylla™ platform

Days Performed

Monday - Friday

Performing Laboratory

Northwell Health Laboratories

CPT

81235,88381

PDM

238469

Only Orderable at Locations:

Orderable Everywhere

Results

Result Interpretation

Negative for EGFR Mutations Listed

Limitations;  This assay is qualitative and is not intended to detect minimal residual diseas. The assay detects G719A, G719C

and G719S mutations but does not distinguish between each variant. Any of the 3 mutations will be reported as G719A/C/S.

The assay relies on primers designed to detect specific deletions in Exon 19, and insertions in Exon 20. While most are

covered by the assay, some, not covered by the primers, might not be detected. Mutations present below the limit of detection

of the assay (5%) might not be detected

Forms
LAB14277 build edit