Implementation of a next-generation sequencing and PD-L1 immunohistochemistry reflex testing protocol for non-small cell lung cancers improves turnaround time

Abstract

Objective: Targeted therapy in non-small cell lung cancer (NSCLC) is now often included as first-line treatment in the neoadjuvant and adjuvant settings. Delays in optimizing treatments based on biomarker status can affect outcomes. Therefore, we assessed the turnaround time (TAT) of reflex biomarker testing for all NSCLCs clinical stage 1B and greater.

Methods: A next-generation sequencing (NGS) and PD-L1 immunohistochemistry reflex protocol for NSCLC clinical stage 1B and greater was implemented. Turnaround time intervals between procedure date, pathology sign-out, date received in the molecular laboratory, and date of NGS sign-out were calculated. Median and IQR of each interval before and after implementation of the reflex protocol were calculated and compared using the Mann-Whitney U test.

Results: In total, 492 lung cancer NGS cases were identified, 351 before and 141 after implementation of the reflex protocol. The prereflex cases, after exclusion of biomarker testing ordered on older blocks and outside consults (n = 165), demonstrated a 22-day median time from procedure to NGS sign-out (range, 11-70 days; IQR, 9; mean, 24 days), compared to a 20-day median time (range, 13-54 days; IQR, 4.5; mean, 21 days) postimplementation (n = 120) (P < .000103).

Conclusions: Reduction in median TAT from procedure to NGS sign-out was statistically significant after implementation of reflex biomarker testing in NSCLC samples.

Keywords: NGS testing; PD-L1 testing; immunohistochemistry; non–small cell lung cancer; operations; targeted therapy; turnaround time.