Abstract 6474: Real-world assessment of turn-around time for actionable variant testing in NSCLC in the community setting
Authors: D'Alessio Brittany , Stephen Adam , Cochran Colin , Hager Cole , Velasco Zachariah , Weaver Amanda , Jackson Leisa , Riley Janice , Tubbs Alisa , Pestano Gary A. 
Published: March 2024

Introduction: Rapid turnaround times (TAT) is a key parameter when evaluating the performance of cell free (cf) nucleic acid testing in clinical oncology practice. The purpose of this study was to evaluate the impact of the real-world factors on TAT for actionable variants in NSCLC, detected using commercially available molecular diagnostic tests. These test services are run in a single, centralized laboratory site and utilized primarily by practices in the community across the United States.

Methods: In this study, de-identified reference data was reviewed for a ddPCR test that evaluates hotspot mutations including Single Nucleotide Variants (SNV), Insertions and Deletions (INDEL), and gene fusions. The NGS panel additionally tests for Copy Number Amplification (CNA) mutations. Specimen processing was initiated when the specimen was entered into the Laboratory Information System (LIS) and ended when the test result was ready for release. The turnaround time evaluation excluded holidays, and weekends unless the start or end-point occurred on a non-business day.

Results: In total, 35,441 specimen results were analyzed. Specimens were typically received in the laboratory within 24 hours of being shipped (88% in 24 hours). Tests by ddPCR included 30,490 (86%) results, while NGS testing accounted for 4,951 (14%) of results. The average analytic lab processing TAT for the ddPCR and NGS test ranged between 2 and 3 days (ddPCR median = 24.5 hours; NGS panel median = 69.7 hours). When no information was missing on the specimen test request form, the turn-around time for the ddPCR tests averaged 30.2 hours and NGS panel averaged 66.2 hours. The percentage of missing or inaccurate information was similar when test requests were initially received. The largest impact factor impacting initiation of specimen processing was information related annotation of the stage of cancer, followed by demographic information related to patient and specimen identifiers.

Conclusion: The focus on rapid turnaround times from specimen collection to results released is critical in oncology. Site and patient information, shipping methods, technologies and workflows used in the laboratory are all part of the test process and impact the release of potentially actionable results. Our study has highlighted that rapid turnaround of results is highly feasible for molecular tests being sent out from community practices across the US to a centralized reference laboratory. Specifically, actionable variant results related to NSCLC were successfully detected in the laboratory and were ready for delivery in 2 to 3 days. Automated methods for parsing the information necessary for test requests and delivery will continue to be important in maintaining rapid test result turnaround times.

Citation Format: Brittany D'Alessio, Adam Stephen, Colin Cochran, Cole Hager, Zachariah Velasco, Amanda Weaver, Leisa Jackson, Janice Riley, Alisa Tubbs, Gary A. Pestano. Real-world assessment of turn-around time for actionable variant testing in NSCLC in the community setting [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 6474.