KRAS

ADDENDUM (K-RAS MOLECULAR DIAGNOSTIC FINDINGS):
KRAS MUTATION ANALYSIS:

INTERPRETATION:
MUTATION DETECTED ON CODON 12
MUTATION DETECTED ON CODON 13
NO MUTATION DETECTED IN CODON 12 AND 13 OF KRAS GENE.
QNS, INADEQUATE SPECIMEN OR LESS THAN 50% TUMOR CELLS PRESENT IN THE TISSUE

SUMMARY OF RESULTS:

GENE     VALUE                  INTERPRETATION


KRAS     NONE                   NO MUTATION IN CODON 12 AND 13

KRAS     QNS                    NO MUTATION

KRAS     GLY12SER (C.34 G>A)    MUTATION

KRAS     GLY12CYS (C.34 G>T)    MUTATION

KRAS     GLY12ARG (C.34 G>C)    MUTATION

KRAS     GLY12ASP (C.35 G>A)    MUTATION

KRAS     GLY12VAL (C.35 G>T)    MUTATION

KRAS     GLY12ALA (C.35 G>C)    MUTATION

KRAS     GLY13ASP (C.38 G>A)    MUTATION

THIS TEST WAS PERFORMED ON USS--, BLOCK BY THE UNIVERSITY OF FLORIDA DIAGNOSTIC REFERENCE LABORATORIES. ADENOCARCINOMA IDENTIFIED ON H&E SLIDE.

TEST DESCRIPTION:
THE TEST DETECTS 7 KRAS GENE MUTATIONS AT CODON 12 AND 13, THE MUTATIONS AT THESE TWO CODONS ARE LINKED TO RESISTANCE TO CANCER THERAPIES THAT TARGET TO THE EGFR PATHWAY IN COLORECTAL AND OTHER CANCERS. TO DETECT THE GENE MUTATION, TISSUE CONTAINS HIGH PERCENTAGE OF TUMOR ARE MANUALLY DISSECTED FROM A FORMALIN-FIXED, PARAFFIN-EMBEDDED SPECIMEN. DNA IS ISOLATED FROM THE DISSECTED TISSUE, KRAS CODON 12 AND 13 REGION IS PCR AMPLIFIED, AND PYROSEQUENCE IS USED FOR THE MUTATION DETECTION.
MUTATIONS THAT CAN BE DETECTED IN THIS TEST: GLY12SER (C.34 G>A), GLY12CYS (C.34 G>T), GLY12ARG (C.34 G>C), GLY12ASP (C.35 G>A), GLY12VAL (C.35 G>T), GLY12ALA (C.35 G>C), GLY13ASP (C.38 G>A).

THE PERFORMANCE CHARACTERISTICS OF THIS TEST WERE VALIDATED BY UNIVERSITY OF FLORIDA-PATHOLOGY LABORATORIES. THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS NOT APPROVED OR CLEARED THIS TEST. HOWEVER, FDA APPROVAL OR CLEARANCE IS CURRENTLY NOT REQUIRED FOR CLINICAL USE OF THIS TEST. THE RESULTS ARE NOT INTENDED TO BE USED AS THE SOLE MEANS FOR CLINICAL DIAGNOSIS OR PATIENT MANAGEMENT DECISIONS. UF PATHOLOGY LABORATORIES IS AUTHORIZED UNDER CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) AND BY ALL STATES TO PERFORM HIGH-COMPLEXITY TESTING.

THE ABOVE TESTING WAS PERFORMED AT UNIVERSITY OF FLORIDA PATHOLOGY LABORATORIES, 4800 SW 35TH DR., GAINESVILLE, FL 32608. PHONE: 352-265-9900.