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KRAS Mutation Analysis by Next Generation Sequencing

Test Code

M KRAS

Associations

EGFR inhibitor, Colorectal cancer, NSCLC;

Tyrosine kinase inhibitors (TKI):  Erbitux® (cetuximab), Vectibix™ (panitumumab)

Methodology

Next Generation Sequencing Targeted HotSpots
QIAGEN® Human Tumor Actionable Mutations Panel (GeneRead™ DNAseq Targeted Panels V2) for targeted enrichment

Turnaround Time

7-10 days

Specimen Requirements

Formalin Fixed Paraffin Embedded tissue block or slides (3-5 slides at 5 micron minimum) NOTE: Include a surgical pathology report with the sample
5.0 mL (min. 3.0 mL) whole blood EDTA, Sodium Heparin or ACD
3.0 mL (min. 1.0 mL) bone marrow EDTA, Sodium Heparin or ACD

Specimen Stability
Indefinite at ambient temperature (18-25°C) Whole blood and Bone Marrow stable at 18-25°C for 72 hours or 4°C for up to 7 days
Storage & Handling

Ship at ambient temperature, cool in summer. (Do not allow cool/refrigerated pack to directly contact sample)

Causes for Rejection

Improper specimen labeling; Insufficient sample volume; Clotted specimen; Specimen older than 7 days

Description

Utilized as an independent predictor of colorectal cancer (CRC) and patient responsiveness to EGFR (TKI) inhibitor therapy.

References
  1. Sepulveda et al.  (2017)  Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and the American Society of Clinical Oncology.  J Clin Oncol. 2017 Feb 6:JCO2016719807
  2. Neumann J et al. Epub 2009 Frequency and type of KRAS mutations in routine diagnostic analysis of metastatic colorectal cancer. Pathol. Res.Pract. 205(12), 858.
  3. Siena S et al (2009). Biomarkers Predicting Clinical Outcome of Epidermal Growth Factor Receptor - Targeted Therapy in Metastatic Colorectal Cancer. JNCI. 101: 1308-1324
  4. Allegra C J et al. (2009). ASCO Provisional Clinical Opinion: Testing for KRAS Gene Mutations in Patients with Metastatic Colorectal Carcinoma to Predict Response to Anti-Epidermal Growth Factor Receptor Monoclonal Antibody Therapy. JCO. 27: 2091-2096
  5. V. Shankaran et al. (2009). Economic implications of Kras testing in metastatic colorectal cancer (mCRC). Gastrointestinal Cancers Symposium. Abstratct No. 298.
  6. Tol J. (2009). Chemotherapy, bevacizumab and cetuximab in metastatic colorectal cancer. N Engl J Med. 360:563-72.
  7. De Roock W et al. (2008). KRAS wild-type state predicts survival and is associated to early radiological response in metastatic colorectal cancer treated with cetuximab. Ann Oncol. 19:508-515.
  8. Karapetis CS et al. (2008). K-ras Mutations and benefit from cetuximab in advanced colorectal cancer. NEJM. 359:1757-1765.
  9. Lievre A et al (2008). KRAS mutations as an independent prognostic factor in patients with advanced colorectal cancer treated with cetuximab. J Clin Oncol. 26:374-379.
  10. NCCN Practice Guidelines v.3.2008. http://www.nccn.org .
  11. Di Fiore F et al. (2007). Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by Cetuximab plus chemotherapy. Br J Cancer. 96:1166-1169.
  12. Lievre A et al. (2007). KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res. 66:3992-3995.
Trademarks

Qiagen and GeneRead are trademarks of Qiagen