Multicenter Evaluation of the Idylla GeneFusion in Non-Small-Cell Lung Cancer.

Targeted therapy in lung cancer requires the assessment of multiple oncogenic driver alterations, including fusion genes. This retrospective study evaluated the Idylla GeneFusion prototype, an automated and ease-of-use (<2 minutes) test, with a short turnaround time (3 hours) to detect fusions involving ALK, ROS1, RET, and NTRK1/2/3 genes and MET exon 14 skipping. This multicenter study (18 centers) included 313 tissue samples from lung cancer patients with 97 ALK, 44 ROS1, 20 RET, and 5 NTRKs fusions, 32 MET exon 14 skipping, and 115 wild-type samples, previously identified with reference methods (RNA-based next-generation sequencing/fluorescence in situ hybridization/quantitative PCR). Valid results were obtained for 306 cases (98%), overall concordance between Idylla and the reference methods was 89% (273/306); overall sensitivity and specificity were 85% (165/193) and 96% (108/113), respectively. Discordances were observed in 28 samples, where Idylla did not detect the alteration identified by the reference methods; and 5 samples where Idylla identified an alteration not detected by the reference methods. All of the ALK-, ROS1-, and RET-specific fusions and MET exon 14 skipping identified by Idylla GeneFusion were confirmed by reference method. To conclude, Idylla GeneFusion is a clinically valuable test that does not require a specific infrastructure, allowing a rapid result. The absence of alteration or the detection of expression imbalance only requires additional testing by orthogonal methods.

The role and functioning of environmental assessment: theoretical reflections upon an empirical investigation of causation.

Environmental assessment is an intriguing policy phenomenon: it is employed in an ever-increasing range of contexts the world-over, yet research indicates it rarely efficiently or effectively achieves its principal purpose of promoting sustainable development. Increasingly, practical limitations in the effectiveness of environmental assessment are attributed to its theoretical shortcomings, particularly in relation to the conception of causation. This research advanced debate on environmental assessment by examining the theoretical implications of an empirical analysis of its causal operation in purposefully selected cases. The causal models derived from the research data illustrate the diversity of mechanisms through which environmental assessment can contribute to sustainability, and provide an insight into the complexity and contextuality of causation in the empirical realm. The research findings also highlight a multiplicity of societal expectations concerning environmental assessment's contribution to sustainable development. It is concluded that the interplay of non-rational variables (such as power, agency, experiences and expectations) necessitates the pursuit of a reflexive accommodation of purposes, methods and context in environmental assessment practices.

The contribution of environmental assessment to sustainable development: toward a richer empirical understanding.

It has long been suggested that environmental assessment has the potential to contribute to sustainable development through mechanisms above and beyond informing design and consent decisions, and while theories have been proposed to explain how this might occur, few have been subjected to rigorous empirical validation. This research advances the theoretical debate by building a rich empirical understanding of environmental assessment's practical outcomes, from which its potential to contribute to sustainable development can be gauged. Three case study environmental assessment processes in England were investigated using a combination of data generated from content analysis, in-depth interviews, and a questionnaire survey. Four categories of outcomes are delineated based on the research data: learning outcomes; governance outcomes; attitudinal and value changes; and developmental outcomes. The data provide a robust critique of mainstream theory, with its focus on design and consent decisions. The article concludes with an examination of the consequences of the context-specific nature of environmental assessment practices in terms of developing theory and focusing future research.