Related Experiment Video
Updated: Jan 16, 2026
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Implementation of a next-generation sequencing and PD-L1 immunohistochemistry reflex testing protocol for non-small
C Kendall Major1,2, Chiara J Cocelli2, Polina Khrizman1,2
1MD Anderson Cancer Center at Cooper, Camden, NJ, United States.
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.
Insights
Implementing reflex biomarker testing significantly reduced turnaround times for non-small cell lung cancer (NSCLC) patients. This optimization ensures faster biomarker status determination, crucial for timely targeted therapy in NSCLC.
Area of Science:
- Oncology
- Molecular Diagnostics
- Clinical Pathology
Background:
- Targeted therapy is increasingly used in early-stage non-small cell lung cancer (NSCLC).
- Timely biomarker testing is essential for treatment optimization.
- Delays in biomarker results can negatively impact patient outcomes.
Purpose of the Study:
- To assess the impact of a new reflex biomarker testing protocol on turnaround time (TAT).
- To evaluate the efficiency of next-generation sequencing (NGS) and PD-L1 testing in NSCLC.
Main Methods:
- A reflex protocol for NGS and PD-L1 immunohistochemistry was implemented for NSCLC (stage 1B+).
- Turnaround time intervals were measured before and after protocol implementation.
- Statistical comparison using the Mann-Whitney U test was performed.
Main Results:
- A total of 492 NSCLC cases were analyzed (351 pre-protocol, 141 post-protocol).
- Median TAT from procedure to NGS sign-out decreased from 22 days to 20 days post-implementation.
- This reduction in TAT was statistically significant (P < .000103).
Conclusions:
- Implementing reflex biomarker testing significantly reduced median TAT for NSCLC.
- This optimization streamlines the process of obtaining critical biomarker information for treatment decisions.
