Split Scan EGFR Lung cancer in Indonesia​

Lung is an organ in the human body that has a very important role. Various types of diseases attack human lung organs, one of which is lung cancer. Lung cancer is cancer that occurs in the cells of the airway wall of the lung organs. These abnormal cells divide uncontrollably and form a solid mass or what we know as tumours. The number of lung cancer incidents in Indonesia has increased over time and occurs at a younger age compared to other countries. In 2022, the GLOBOCAN reported 30,023 new cases of lung cancer in Indonesia and 26,095 deaths, making up around 2.6% of Indonesia’s total deaths.​

There are two types of lung cancer, namely small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). Non–small-cell lung cancer (NSCLC) accounts for approximately 85% of lung cancer. Recent advances in lung cancer research have resulted in the identification of several mutations that contribute to the carcinogenesis of NSCLC. The epidermal growth factor receptor (EGFR) is encoded by one of the most commonly mutated genes in NSCLC. EGFR mutations are now well recognized as the most potent predictive biomarkers of treatment outcome to first-line EGFR-tyrosine kinase inhibitors, confirming the need for accurate, timely EGFR mutation testing worldwide.​

About the Kit​

The need for mutation testing in the EGFR gene, the IVD team conducted research to develop an EGFR mutation detection kit in two exons, namely exons 19 and 21. Collaborating with PT. KalGen DNA, IVD-SCI team produced the kit under the name Split Scan EGFR 2 Exons. Split Scan EGFR 2 Exons kit is a high resolution melting (HRM) real-time polymerase chain reaction (PCR)-based in vitro diagnostic assay intended for the qualitative screening of mutation in exons 19 and 21 of Epidermal Growth Factor Receptor (EGFR) gene in the specimen of non-small cell lung cancer (NSCLC) patients. ​

Split Scan EGFR 2 Exons kit is high resolution melting (HRM) real-time PCR-based kit. The first step in our method is amplification of the target DNA and the second step is the HRM step, which will generate a unique pattern that can be observed in the melt curve produced in the HRM step. Firstly, the real-time PCR machine captures fluorescence emitted by the dye added into the PCR mixture. This dye intercalates into double-strand DNA produced during the amplification process. Then, in the high-resolution melting stage, double-strand DNA “melts” into single-strand DNA, which will change the fluorescence level. The changes in fluorescence are captured by the detector in the real-time PCR machine and plot of fluorescence changes against temperature is displayed as melt curve. Samples with wildtype genotype status will show a single peak, meanwhile samples with mutant genotypes in exon 19 or 21 will show split peaks. Wildtype and mutant genotypes can be differentiated based on this unique pattern observed in the melt curve. Only a portion of the samples need to be further tested, using sequencing or another genotyping method. ​

Split scan EGFR 2 exons is an open system kit that can be used on various types of validated real-time PCR. This is an advantage, considering that after the COVID-19 pandemic, almost all regions in Indonesia have real-time PCR tools. Therefore, we hope that the development of the kit can make it easier for lung cancer patients to get access to affordable and quality examinations.​