Predictive molecular pathology in non–small cell lung cancer in France: The past, the present and the perspectives

Abstract

The advent of molecular targets for novel therapeutics in oncology, notably for non–small cell lung carcinoma (NSCLC), led the French National Cancer Institute (INCa) to establish a national network of 28 hospital Molecular Genetics Centers for Cancer (MGCC) in 2007. In each University in France, laboratories were established to develop molecular biology testing to evaluate a few genomic alterations, initially a selection of genes, by using specific targeted polymerase chain reaction (PCR) assays. In a second phase, the number of studied genes was increased. In 2015, the MGCC benefited from an additional dedicated budget from the INCa to develop next‐generation sequencing (NGS) technology. In the meantime, a new financial regulation for innovative testing has been established for the acts out of nomenclature. Consequently, all private and public laboratories in France have access to funding for molecular biology testing in oncology. The gene‐based PCR assays or NGS tests have benefitted from reimbursement of cost testing by the INCa. Today, the laboratories consider this reimbursement to be only partial, and its use to be complex. In 2018, a strategic plan for medical genomic analyses (France Médecine Génomique 2025) was implemented to introduce more systematic sequencing into the health care pathway and oncology practice. The large panel of molecular tests should be centralized to a limited number of molecular genetic centers. This review describes the evolution of the different stages of implementation of molecular pathology testing for NSCLC patients over the last few years in France.

Lung Cancer in France

“…The first period of the implementation of routine molecular profiling was led by the National Cancer Institute in 2007. 7 A total of 28 hospital molecular genetics centers for cancer were labeled to carry out molecular profiling (at least one genetic center in each administrative region). Different analytical approaches were used, including Sanger sequencing and more sensitive approaches, such as pyrosequencing or allele-specific polymerase chain reaction.…”

EGFR Status Assessment for Better Care of Early Stage Non-Small Cell Lung Carcinoma: What Is Changing in the Daily Practice of Pathologists?

“…Reliance on the sequencing strategy as a reflex test has a strong impact on the associated cost of molecular biological tests and can be discussed according to the mode of reimbursement of these tests by institutions, local organizations, and/or countries [83][84][85]. Thus, a strategy of reflex testing by NGS can be influenced by the capacity to finance these tests [67,68,86].…”

“…Thus, a strategy of reflex testing by NGS can be influenced by the capacity to finance these tests [67,68,86]. As an example, in France, the invoice associated with these tests is sent to the physicians (oncologists in the majority of cases) who ask for the molecular biology prescription [83]. As a matter of fact, the NGS tests are partially reimbursed in France,…”

“…Thus, a strategy of reflex testing by NGS can be influenced by the capacity to finance these tests [67,68,86]. As an example, in France, the invoice associated with these tests is sent to the physicians (oncologists in the majority of cases) who ask for the molecular biology prescription [83]. As a matter of fact, the NGS tests are partially reimbursed in France, which incites many oncologists, notably those working in private health care systems, to prescribe RT-PCR tests for the detection of genomic alterations only associated with therapeutic molecules that have received EMA authorization and which are reimbursed [83].…”

The roles and mechanisms of the circular RNA circ_104640 in early-stage lung adenocarcinoma: a potential diagnostic and therapeutic target

“…In recent years, the use of LDCT to detect early-stage LC has increased by 74.1% (8). Additionally, circulating tumor cells (CTCs), circulating tumor DNAs (ctDNAs), and exosomes have gradually become more vital in the early diagnosis of LUAC (9)(10)(11). Continuous progress is being made to develop novel early-stage LUAC diagnostic methods.…”