Clinical Utility Validation of an Automated Ultrarapid Gene Fusion Assay for NSCLC

ABSTRACT:

Introduction

Gene rearrangements are frequent oncologic drivers in NSCLC, and many are suitable for treatment with Food and Drug Administration–approved or experimental targeted therapies. We evaluated the accuracy, specimen acceptance profile, and limits of detection of a rapid fusion assay (Idylla GeneFusion Assay), a commercially available ultrarapid molecular assay, for its clinical utility.

Methods

A collection of 97 specimens which had previously undergone next-generation sequencing testing were analyzed using the rapid fusion assay. Accuracy was evaluated by sensitivity and specificity compared with the next-generation sequencing results. The performance characteristics were tested by using a variety of different clinically relevant specimen types. Limits of detect

SUBMITTER: Buglioni A 

PROVIDER: S-EPMC9758522 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature