Colorectal Cancer Panel (CE-IVD)

Colorectal Cancer Panel (CE-IVD)

Oncology

Regulatory Status: CE-IVD, AUSTRALIA-IVD, HSA (Singapore)

DESCRIPTION

Colorectal cancer (CRC) is the most common cancer affecting males and 2nd most common after breast cancer for females in Singapore (1). Globally, CRC is the third most common type of cancer making up about 10% of all cases (2). In 2012, it resulted in 1.4 million new cases and caused 694,000 deaths (2).  Screening for the mutation status of key genes such as KRAS, NRAS and BRAF can predict patient response to therapies.  Professional bodies such as American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) both recommend KRAS mutation testing prior to prescribing EGFR antagonist therapy for patients with metastatic cancer, and also highlight that alternative therapy be used when mutations are detected (3, 4).

This test is intended to aid the oncologist in making therapeutic decisions. Results should be used in conjunction with other available laboratory and clinical information and are not intended for use as a stand-alone diagnostic test or disease monitoring.

SAMPLE REQUIREMENT

10 μm section of FFPE biopsy tissue

TURNAROUND TIME

Please contact us for more information.

TARGET GENES

28 amplicons, 112 mutations
NRAS
CTNNB1
PIK3CA
FGFR3
KIT
EGFR
BRAF
RET
PTEN
KRAS
TP53

 

REFERENCES

  1. Singapore Cancer Registry Annual Report 2015.
  2. World Cancer Report 2014. World Health Organization. 2014. Chapter 1.1. ISBN 9283204298.
  3. Allegra CJ, Jessup JM, Somerfield MR, et al. American Society of Clinical Oncology 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. J Clin Oncol.2009;27:2091-2096.
  4. NCCN Clinical Practice Guidelines in Oncology.  J Natl Compr Canc Netw 2017;15:370-398.