Progress and Gaps in Lung Cancer Biomarker Testing at Community Centers

A critical implementation gap remains in cancer care. While we know targeted therapies save lives, the challenge lies in ensuring that every patient, regardless of whether they are at a major academic hub or a regional community site, gets the comprehensive testing needed to access them.

A recent study published in JCO Oncology Practice evaluates how effectively Dana-Farber Cancer Institute (DFCI) regional sites are following clinical guidelines for biomarker testing in patients with advanced non–small cell lung cancer (NSCLC) between 2018 and 2021. Our primary rationale was to address a specific gap in the current literature regarding practice models. While we know that biomarker testing is critical for guiding treatment in advanced NSCLC, there has long been a concern that testing rates in community settings lag behind those in academic centers. However, there is very little data specifically describing testing rates in community practices that are closely affiliated with academic centers. As this "hybrid" model becomes more common, we felt it was important to determine if these affiliations successfully bridge the gap in guideline-concordant testing.

Based on our experience and the broader landscape, the barriers are often logistical and financial rather than educational. Key challenges include the lack of standardized reimbursement policies, which can vary significantly by payer and region, and the operational complexity of tissue handling. Without close collaborative workflows between oncologists, pathologists, and testing vendors, issues like insufficient tissue quantity, long turnaround times, or simply the lack of a reflex testing protocol can significantly hinder the incorporation of routine testing.

The successes of the research showed that testing for "established" biomarkers like EGFR, ALK, and PD-L1 was impressively high, exceeding 85% in nonsquamous cases. However, there was a lag in testing for newer or rarer targets (such as BRAF and MET) trailed behind, ranging from 55% to 71%. Perhaps most notably, 45% of patients did not receive next-generation sequencing, often considered the gold standard for catching a broad spectrum of mutations at once. While NGS testing started low in squamous cases (14% in 2018), it surged to 61% by 2021, showing a rapid evolution in clinical practice.

I was most struck by the significant increase in the use of large NGS panels for patients with squamous NSCLC. Historically, we have associated targetable genomic alterations primarily with nonsquamous histology. To see such a rapid rise in broad panel testing for squamous disease, where targetable mutations are far less common, was surprising. It likely reflects a shift toward broader, more inclusive testing protocols rather than histology-specific selection.

I believe this rise in testing in squamous disease is driven by a combination of evolving reimbursement policies and the operational simplification of testing workflows. As coverage for NGS has expanded to advanced cancer in general, it has become easier for clinicians to order broad panels for all NSCLC patients rather than segregating by histology. Furthermore, the increasing availability and ease of use of liquid biopsy likely contributed to this rise, allowing for broad genomic profiling even when tissue samples were limited or difficult to obtain in squamous cases.

While our study focused on testing rates, clinically there are several reasons why a patient with an actionable driver might not receive targeted therapy. Common reasons include a rapid decline in performance status that makes systemic therapy unfeasible, or the patient choosing to pursue hospice care. In some cases, there is a timing mismatch; if testing results are delayed, a patient might start chemotherapy urgently before the driver mutation is identified. Additionally, during the study period, some therapies may have been newly approved, leading to a lag in access or insurance coverage for specific agents. Finally, there may be an indication mismatch; not all patients whose tumors harbor actionable biomarkers meet clinical criteria to require targeted therapy.

The main takeaway is a reassuring one: high rates of guideline-concordant biomarker testing are achievable in the community setting. The findings suggest that with the right support, and especially with close collaboration with pathologists and testing vendors, community oncologists can provide care that mirrors the quality of academic centers. It emphasizes the importance of establishing these workflows to ensure that patients have access to the latest targeted therapies immediately following regulatory approval.

We need to investigate how effectively testing is diffusing for "newer" novel biomarkers that may not be included on all standard panels, such as MET amplification. Additionally, a critical next step is to examine biomarker testing in early-stage NSCLC. With the increasing importance of adjuvant and neoadjuvant targeted therapies (for example, in EGFR- and ALK-positive disease), understanding the accessibility and implementation of testing in the curative-intent setting is a vital unanswered question.

REFERENCE

Farhat K, Paul MA, Roby L, et al. Biomarker Testing for Non-Small Cell Lung Cancer in Community Practices Operated by an Academic Cancer Center. JCO Oncol Pract. 2025 Nov 10:OP2500280. doi: 10.1200/OP-25-00280. Epub ahead of print. PMID: 41213102.