Table 4.

Timeline of Milestones in Molecular Testing of NSCLC in Mainland People’s Republic of China

Year	Key Milestones in Release of Guidelines or Expert Consensus, NMPA Approval of IVD and CDx Devices in Molecular Testing of Lung Cancer in Mainland People’s Republic of China
2010	First EGFR mutation testing in vitro diagnostics device approval by CFDA
2011	Consensus on epidermal growth factor receptor gene mutation detection in NSCLC
2013	The diagnosis and treatment guideline of Chinese patients with EGFR mutation and ALK fusion gene-positive NSCLC (2013 version)
2014	The diagnosis and treatment guideline of Chinese patients with EGFR gene active mutation and ALK fusion gene-positive NSCLC (2014 version)
2015	The guideline for diagnosis and treatment of Chinese patients with sensitizing EGFR mutation or ALK fusion gene-positive NSCLC (2015 version)
2015	Guideline of construction of molecular pathological laboratory
2015	Screen of ALK-positive NSCLC by routine immunohistochemistry: an expert consensus
2015	Consensus on epidermal growth factor receptor cell-free DNA mutation detection in NSCLC
2016	Updated consensus on epidermal growth factor receptor gene mutation detection in NSCLC
2017	Expert consensus on next-generation gene sequencing detection in clinical molecular pathological laboratory
2018	Expert consensus on diagnosis of ROS1 gene fusion-positive NSCLC
2018	Four NGS in vitro diagnostics devices for lung cancer mutation detection approval by NMPA
2019	Expert consensus on clinical practice of ALK fusion detection in NSCLC in China

CDx, companion diagnostic; CFDA, China Food and Drug Administration; IVD, in vitro diagnostic; NGS, next-generation sequencing; NMPA, National Medical Products Administration.