Just a few days ago we covered Pineault et al, clinical behavior around ordering molecular testing in NSCLC. Find the blog here: https://www.discoveriesinhealthpolicy.com/2026/08/clinical-behavior-in-genomics-new-paper.html
Don't miss a similar article, but in breast cancer, by Kohle et al., August 2026 in J Molec Dx. Find it here: https://www.jmdjournal.org/article/S1525-1578(26)00086-3/fulltext
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AI Corner: Summary of Kohle
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This 2026 Journal of Molecular Diagnostics consensus statement argues that pathologists should play a substantially larger role in molecular biomarker testing for metastatic breast cancer (mBC). Although NGS can identify actionable alterations, resistance mechanisms, and molecular subtypes relevant to therapy, comprehensive genomic profiling remains underused: the authors cite an estimate that only about 7% of patients with mBC receive it.
The paper is based on semistructured interviews with 19 U.S. pathologists from academic, community, and central-laboratory settings. Current practice generally leaves treatment-related biomarker ordering to oncologists, while pathologists focus on tissue adequacy, interpretation, quality assurance, and conventional markers such as ER, PR, HER2, and Ki-67. The authors argue that pathologists’ expertise in tissue selection, assay choice, histopathologic context, NGS interpretation, and laboratory quality makes them well suited to participate earlier and more proactively.
Major barriers include fragmented education, lack of standardized institutional workflows, limited access to send-out molecular results, insufficient molecular-pathology training, administrative resistance, reimbursement and prior-authorization burdens, and institutional emphasis on surgical volume rather than molecular programs. Community practices face particular disadvantages because they more often depend on send-out testing, increasing turnaround time and reducing integration with tumor boards.
The authors recommend greater pathologist participation in molecular tumor boards, standardized reflex-testing protocols, stronger molecular education, more in-house testing where feasible, clearer reimbursement pathways, and closer pathology-oncology collaboration. The page 3 diagram organizes these proposals into four areas: education/resources, institutional leadership, multidisciplinary collaboration, and insurance/health policy. Ultimately, the paper frames pathologists not merely as test interpreters but as potential leaders of institution-wide biomarker strategies that can reduce redundant testing, conserve tissue, shorten turnaround time, improve testing equity, and better connect genomic findings to treatment decisions.
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COMPARE KOHLE, PINEAULT
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Kohle and Pineault reach essentially the same destination—greater pathologist ownership of molecular testing—but Pineault supplies much stronger evidence that this model is already functioning in practice.
Kohle et al. addresses metastatic breast cancer and is primarily a consensus/advocacy statement. Based on interviews with 19 pathologists, it argues that oncologists still usually initiate treatment-related biomarker testing, leaving pathologists in consultative roles despite their expertise in tissue selection, test choice, interpretation, quality assurance, and tumor-board integration. The authors call for standardized protocols, more molecular training, stronger institutional leadership, and reimbursement policies that permit greater pathologist involvement.
Pineault et al., studying NSCLC, is more concrete and quantitative. In a national survey, 77.5% of respondents reported standardized comprehensive biomarker-testing protocols, and 88.4% of those protocols included reflex multigene testing. Importantly, where reflex protocols existed, pathologists were the predominant ordering providers: 68.3% reported pathologist ordering, versus 12.2% using an oncologist standing order.
Thus Pineault effectively demonstrates the operational model that Kohle advocates: diagnosis can trigger guideline-driven molecular testing without waiting for a subsequent oncology order. Both identify reimbursement, institutional workflows, education, and multidisciplinary coordination as barriers. But Pineault goes further into CMS policy, explicitly supporting recognition of pathologists as valid ordering physicians and highlighting insurance authorization and the Medicare 14-day rule.
In shorthand: Kohle says “pathologists should own more of the process”; Pineault shows that in lung cancer they often already do—and argues CMS policy should catch up.
