Optimization of Turnaround Time and Insufficient Quantity Frequency for Molecular Testing on FFPE Material

Abstract Introduction/Objective With clinical decisions relying progressively more on molecular data extracted from formalin- fixed, paraffin-embedded (FFPE) tissue, it is pivotal to optimize the use of tissue for diagnostic and prognostic purposes. This optimization can be reached by identifying actionable instances that can decrease the turnaround time (TAT) and the rate of “quantity not sufficient” (QNS) results Methods/Case Report From January 2023 to December 2023, the total TAT from the time a molecular study is ordered to its delivery to the molecular lab at LL200A (Tomsich Laboratories), as well as the TAT from the time between the ordering pathologist circling the region of interest to its delivery to LL200A were broken down by subspecialty and site. In addition, the QNS results of Caris genomic profiling were evaluated considering subspecialty and site, amount of material present in the initial sample, and number of levels cut for other ancillary testing from the same material. Results (if a Case Study enter NA) 83% of subspecialties took longer than 48 hours to have material ordered for molecular studies delivered to LL200A. The median TAT for all specialties was 58 hours (average: 71.6 hours). When examining TAT from circling to LL200A, the median time was 19 hours (average: 28.4 hours). Regarding the QNS rate of the Caris assay, most QNS cases were gastrointestinal tract specimens (27%) or specimens obtained from either CT-guided core needle biopsies (30%) or endoscopic biopsies (32%). The longest dimension of QNS cases ranged from 7.5 cm to 0.1 cm (median: 1.3cm)—the average number of slides ordered before Caris ranged from 1 to 52 (median: 12). Conclusion The initial results pointed towards the time from circling to LL200A as one actionable item that could improve the TAT of molecular tests. Possible solutions include enacting a dedicated tumor circling service. In addition, to decrease the rate of Caris QNS results, we propose working together with proceduralists to increase biopsy material yield and to work with pathologists to preserve limited specimens for molecular studies.