CRC NSCLC KRAS Mutations Analysis

Overview
KRAS mutations occur in 40% of colorectal cancer (CRC) and 25% of non-small cell lung cancer (NSCLC) patients, predominantly in codons 12 and 13. KRAS mutation testing is recommended before starting anti-EGFR therapies for CRC and NSCLC. The presence of KRAS mutation is a negative prognostic factor and is associated with resistance to EGFR TKIs.

Clinical Indications Clinical Utility

Colorectal Cancer and Non-Small Cell Lung Cancer. Assists as a predictive marker in the use of anti-EGFR therapies.

Methodology and Interpretation

PCR amplification and pyrosequencing are used to detect mutation(s) in the DNA isolated from the patients biopsy embedded in paraffin (FFPE).

Assay Specifications

Sensitivity The sensitivity of this assay is 12%.

Specimen Requirements 10% neutral buffered formalin-fixed paraffin-embedded (FFPE) tissue. 3-5m thick FFPE sections on positively coated slides. Stored and transported at room temperature. Licensure CAP (Laboratory #: 7191582, AU-ID: 1434060), CLIA (Certificate #: 31D1038733), New Jersey (CLIS ID #: 0002299), New York State (PFI: 8192), Pennsylvania (031978), Florida (800018142), Maryland (1395) CPT Codes 81479, 88381

Reporting Results are reported as positive or negative for mutations in Codons 12 and 13.

TAT 3-5 days

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Patient Name: Sex: q Male q Female Date of Birth: Specimen: Collected: Received: Reported: Clinical Hx:

Accession Number: CGI ID No: Ordering Physician: Client: Client Account No: Client ID No: Client Address: Telephone:

KRAS MUTATION ASSAY SAMPLE REPORT

Results: Master Mix Nucleotide Change Amino Acid Change Frequency % Interpretation: Codon 12 and 13 GGT>GCT G12A 70

Positive for a KRAS G12A mutation. Mutation in codon 12 has been associated with resistance to anti-EGFR therapies. The KRAS oncogene is located at chromosome 12p12.1, and encodes a 21-KD protein (p21ras) involved in the G-protein signal transduction pathway, modulating cellular proliferation and differentiation. Mutations of the KRAS gene are most common in the codons 12 and13, and occur in a large number of human tumors. KRAS mutations are found in 40% of colorectal cancer (CRC) and 25% of non-small-cell lung cancer (NSCLC). KRAS mutation testing is recommended before starting anti-EGFR therapies for CRC and NSCLC. KRAS mutations in codon 12 and 13 can be used as a predictive marker in anti-EGFR treatment management of CRC and NSCLC. Mutations in codons 12 and 13 have been associated with resistance to anti-EGFR therapies. These types of therapies are currently recommended for tumors lacking mutations in KRAS. This assay utilizes polymerase chain reaction (PCR) and Pyrosequencing to detect a mutation in DNA isolated from formalin-fixed paraffin embedded tumors. PCR products are sequenced by Pyrosequencing and then analyzed for a mutation in codons 12 and 13.This assay can identify 12 common mutations located in codons 12 and 13. The sensitivity of this assay is 12% of mutant in a background of wild-type genomic DNA. A negative result cannot entirely exclude the presence of KRAS mutation in the specimen. Mutation results should be interpreted in conjunction with other clinical information.

Description:

End of Report

201 Route 17 North Rutherford NJ 07070 Office 201.528.9200 Fax 201.528.9201 www.cancergenetics.com

041013 2013 Cancer Genetics, Inc. All rights reserved.