Implementation of a multidisciplinary biomarker care pathway to reduce somatic sequencing failure rates in a community cancer center.

Abstract

e23325 Background: Next-Generation Sequencing (NGS) of tumor DNA is critical for guiding targeted cancer therapies, but high rates of specimen failure limit its utility. We sought to evaluate the impact of a quality improvement initiative aimed at reducing these pre-analytic failures. Methods: A Biomarker Care Pathway was developed by the Precision Health team in collaboration with all clinical departments involved in tissue acquisition for NGS at our organization. This Biomarker Care Pathway served as a standardized protocol to maximize tissue quality and quantity for specimens that were known to be sent to NGS, including but not limited to preferred needle gauge, attempting additional needle passes to maximize tissue quantity, suggested incubation times for formalin fixation, and others. We then conducted a pre-post implementation study. The pre-implementation period included all somatic tumor sequencing cases in 2023 (n = 340). Following the implementation of a multidisciplinary Biomarker Care Pathway in January 2024, the post-implementation period included all cases in 2024 (n = 350). The primary outcome was the total sequencing failure rate (Quantity Not Sufficient, QNS). Results: Implementation of the Biomarker Care Pathway resulted in a two-fold reduction in the QNS rate, from 6.2% in 2023 to 2.3% in 2024 (p = 0.01). Additional result types analyzed included Partial QNS (decreased from 4.4% to 2.9%) and Limited Tissue (decreased from 16.8% to 9.4%). Decreases in Limited Tissue, Partial QNS, and QNS rates suggests that implementation of the Biomarker Care Pathway may have contributed to improvements in specimen quality. Complete Profile results increased 72.6% to 85.4% from 2023 to 2024 (p < 0.0001). When tissue is insufficient for a Complete Profile, Limited Tissue results are provided to include the most clinically relevant biomarkers based on histology. Therefore, these Limited Tissue results were combined with Complete Profile results to estimate the number of patients who received a clinically actionable report (89% in 2023 versus 95% in 2024). When Limited Tissue results were instead combined with QNS results and analyzed by organ site of biopsy, decreases were observed for biopsies of the pancreas, liver, colon, and lung among others. Conclusions: A standardized, multidisciplinary Biomarker Care Pathway is a highly effective implementation strategy for reducing NGS failure rates in a community oncology setting. This optimization of pre-analytic workflows significantly increases the number of patients who can potentially benefit from biomarker-driven therapy. N (%) 2023 2024 p-value (two proportion Z-Test)p<0.05 were considered significant. Complete Profile 247 (72.6%) 299 (85.4%) p< 0.0001 Limited Tissue 57 (16.8%) 33 (9.4%) p=0.003 Partial QNS 15 (4.4%) 10 (2.9%) p=0.28 QNS 21 (6.2%) 8 (2.3%) p=0.01 Total Cases 340 (100%) 350 (100%)