NSCLC Panel (CE-IVD)

NSCLC Panel (CE-IVD)

Oncology

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

DESCRIPTION

Lung cancer is the most frequently diagnosed cancer and the leading cause of cancer death, comprising 13% of the total new cancer cases and 19% of the total cancer deaths worldwide (1). In females, lung cancer is preceded by breast and colorectal cancers (1). However, survival rates remain low, where over half of people with lung cancer die within one year of being diagnosed (2). Lung cancer is comprised of two main histologic subtypes: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). Over the past decade, it has become evident that NSCLC is associated with specific ‘driver’ mutations in several oncogenes, including BRAF, EGFR, KRAS, NRAS, PIK3CA, and RET3. Currently, EGFR mutation testing is indicated for several approved drugs, Tarceva® (erlotinib), Iressa® (gefitinib) and Gilotrif® (afatinib), used in the treatment of NSCLC. Many targeted small molecule inhibitors are currently being developed for specific molecularly defined subsets of lung cancer patients (3). These mutations can also provide prognostic information in patients with NSCLC.

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, 113 mutations
BRAF
CTNNB1
EGFR
cKIT
KRAS
NRAS
PIK3CA
PTEN
RET
TP53

 

REFERENCES

  1. Ferlay, et al., (2012). GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11. Lyon, France: International Agency for Research on Cancer; 2013. Available at http://globocan.iarc.fr. Accessed on December 19, 2014.
  2.  S. National Institutes of Health. National Cancer Institute. SEER Cancer Statistics Review, 1975 – 2010.
  3.  Lovly, C. et al., (2014). Molecular Profiling of Lung Cancer. Available at My Cancer Genome website: http://www.mycancergenome.org/content/disease/lung-cancer/ (Updated March 31, 2014). Accessed on October 21, 2014.