Abstract

Discovery of oncogenic genetic alterations in certain NSCLC subgroups, and their use as biomarkers and molecular targets for cancer therapy has been paradigm shifting. This has made early identification of these genetic (EGFR, KRAS, ALK, c-MET, ROS1,PI3K, HER2) mutations pivotal for achieving better clinical outcomes. Various testing guidelines which are reviewed periodically have been unable to keep pace with the rapid technological and scientific advances in the diagnostic field. Lack of awareness and in-depth understanding of the testing guidelines may result in patients potentially missing out on the eligible targeted therapies. A literature search was conducted for molecular testing guidelines in NSCLC, that may have been published in major peer reviewed journal, presented at a major conference or recommended by a local regulatory body. Comparisons were made to identify key commonalities and differences in terms of patient flow, tests recommended, timing of tests and type of tests. A local algorithm was derived to be pressure tested at key testing centres. Digital platforms such as ALK-Testing website (www.alktesting.asia) and virtual reality (VR) simulations were created and utilized to educate and increase awareness on molecular testing amongst all the stakeholders. Review of the major NSCLC molecular testing guidelines and algorithms revealed several potential gaps. Consequently, an updated, a simpler and a potentially cost-efficient molecular testing algorithm for NSCLC patients has been formulated. The algorithm recommends single stage upfront reflex testing for major genetic aberrations (IHC or targeted sequencing) concurrent to histological diagnosis to facilitate tissue preservation and decrease turn-around-time (TAT). Further, to improve the efficiency and TATs for testing, and broaden awareness beyond centres of excellence, an ALK-testing website with information on the various testing facilities, current guidelines and testing protocols was created. Currently, use of liquid biopsies is advocated mainly in NSCLC patients who maybe too fragile, unable to provide a tumor specimen or an apt case for delineating resistant mechanisms. To quantify the impact of the new algorithm, an expansion study involving 4-5 key health centres is planned. Furthermore using VR platform, simulations on tumor heterogeneity and various ALK-testing scenarios have been created for educating the respective stakeholders and driving testing protocols. The modified diagnostic algorithm and education through digital and virtual media has the potential to bring consistency and uniformity in diagnosing patients with NSCLC, who are likely to benefit from targeted therapies. Finally, improvements in efficiency and TAT will inform physicians on management decisions without any unwarranted delays.

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