Standardized protocols for reflexing to a multigene panel for patients with non-small cell lung cancer: prevalence and perceived barriers to comprehensive, pathologist-ordered biomarker reflex testing.

Authors

Lynnette Savaloja Pineault, Nikki Martin, Melissa A Kelly, Robyn L Temple-Smolkin, Alexandra S Brown

Published in

American journal of clinical pathology. Volume 166. Issue 1. Jul 06, 2026.

Abstract

To evaluate the use of standardized protocols for reflexing to broad, multigene panels in non-small cell lung cancer (NSCLC) and identify barriers that limit timely pathologist‑ordered biomarker reflex testing.
A cross-sectional survey was administered to a national sample of health care professionals involved in NSCLC biomarker testing.
Of 111 respondents in the dataset, 77.5% reported using an institutional standardized protocol for comprehensive biomarker testing (CBT), and 88.4% of these protocols included reflexing to a multigene panel. Most respondents with reflex protocols indicated that 80% or more of newly diagnosed patients with NSCLC received CBT; however, fewer respondents reported that results were available before the oncology visit to select first‑line treatment. Pathologists were the primary ordering providers in institutions with standardized protocols. Respondents agreed that pathologist‑ordered reflex biomarker testing improves cancer care and supported Centers for Medicare & Medicaid Services (CMS) recognition of pathologists as ordering physicians for broad biomarker panels. Despite protocol adoption, respondents cited persistent barriers-including reimbursement, insurance authorization delays, and the Medicare 14-day rule.
Locally standardized protocols incorporating reflex multigene panel testing have been reported and are associated with high rates of CBT. Institutional and operational barriers delay the availability of results and limit the impact of these protocols on first‑line treatment decisions. Clarifying CMS guidance on pathologists as valid ordering physicians for broad biomarker panels, strengthening coordination with multidisciplinary teams, addressing workflow constraints, and educating the laboratories and payers on pathologists having ordering authority may enhance the effectiveness and adoption of reflex biomarker testing models.

PMID:
42467547
Bibliographic data and abstract were imported from PubMed on 18 Jul 2026.

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