Regulatory Status: CE-IVD, AUSTRALIA-IVD, HSA (Singapore)
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.
10 μm section of FFPE biopsy tissue
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|28 amplicons, 113 mutations|