Category

Molecular Genetic Pathology & Cytogenetics

Sub Category

Oncology (Solid Tumors)

Synonym/Aliases

Kras Mutation Analysis; Kras Mutation Detection; Kras Codons 12, 13

Abbreviations

N/A

Type

Individual Test

Results

RESULTS READY WITHIN 10 DAYS

Method

PCR / SEQUENCING

Temp

KEPT AT ROOM TEMPERATURE

Setup

BATCHED

Components Parameters

- N/A

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY. CLINICAL HISTORY, HISTOLOGY (H&E) REPORT ARE MANDATORY.

Patient preparation

- N/A

Sample type

TUMOR POSITIVE FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BLOCK.

Container/ preservative

FORMALIN FIXED, PARAFFIN EMBEDDED BLOCKS [PREFERRED]. ALTERNATIVELY, 5 MICRONS UNSTAINED SECTIONS ON POSITIVELY-CHARGED SLIDES (≥FOUR SLIDES) & 1 MATCHING H&E SLIDE.

Sample volume

SUFFICIENT RESIDUAL TISSUE/ TUMOR MUST BE AVAILABLE ON THE BLOCK

Rejection criteria

LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE; INSUFFICIENT SAMPLE; DECALCIFIED SAMPLES.

Other Instructions

- N/A

Reference intervals

INTERPRETIVE DATA IS PROVIDED ON THE REPORT.

Clinical Utility

DETECTS PRESENCE OR ABSENCE OF KRAS CODON 12/13 (EXON 2) MUTATIONS. A PREDICTIVE/ THERANOSTIC MARKER FOR COLORECTAL & NON-SMALL CELL LUNG CANCER. PATIENTS WITH POSITIVE RESULTS INDICATE RESISTANCE TO ANTI-EGFR THERAPY E.G. CETUXIMAB (ERBITUX), PANITUMUMAB (VECTIBIX).

Test Limitations / Confounders

RESISTANCE TO ANTI-EGFR THERAPY MAY OCCUR DUE TO KRAS CODON 61, BRAF MUTATIONS