This page contains archived content from Clinical Value of Biomarker Testing in NSCLC.
Advancing Patient Care Through Biomarker Testing in NSCLC
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Real-World Impact of Comprehensive Genomic Profiling on Biomarker Detection, Receipt of Therapy, and Clinical Outcomes in Advanced Non–Small Cell Lung Cancer
Law JW, et al. JCO Precision Oncol. 2024
This retrospective study included 3,884 patients with advanced NSCLC diagnosed between 2011 and 2023. Of these, 20% received comprehensive genomic profiling (CGP) and 80% received only single-gene testing. CGP identified one or more actionable biomarkers in 32% of patients, compared to 14% with single-gene testing. Patients who received CGP were also more likely to receive matched targeted therapy and had improved overall survival; among treated patients with actionable results, matched therapy was associated with longer median real-world overall survival (rwOS): 34 months vs 14 months for CGP, and 27 months vs 10 months for single-gene testing.
Comprehensive genomic profiling doubled the detection of actionable biomarkers compared to single-gene testing and was associated with higher matched therapy use and significantly longer survival, supporting its clinical value in managing advanced NSCLC.
Association between availability of molecular genotyping results and overall survival in patients with advanced nonsquamous non-small-cell lung cancer
Aggarwal C, et al. JCO Precis Oncol. 2023
In this real-world cohort study, the authors examined electronic health records of 326 patients with newly diagnosed metastatic nonsquamous NSCLC to determine the association between the availability of biomarker testing before initiating therapy and overall survival.
At a 14.2-month median follow-up, patients with biomarker testing results available prior to first-line therapy had significantly longer overall survival rates than patients who did not have results available.
Clinical impact for advanced non-small-cell lung cancer patients tested using comprehensive genomic profiling at a large USA health care system.
Meng et al., ESMO Journal. 2024
Comprehensive genomic profiling identifies more treatable mutations than smaller gene panels, leading to increased targeted therapy use, longer median survival, reduced trial-and-error treatments, and streamlined testing.
In this study sponsored by Illumina (an American biotechnology company), a research team compared two groups of patients, those tested with comprehensive genomic profiling (CGP) and those tested with a smaller 50-gene panel. Their goal was to evaluate how using CGP on patients with advanced non-small-cell lung cancer (NSCLC) could improve treatment decisions and survival outcomes through precision therapies. Despite NSCLC remaining “one of the leading causes of cancer-related deaths worldwide,” access to CGP testing and precision therapies remains untapped due to “the cost of testing, physician unfamiliarity with testing strategies, patient lack of insurance, or insurance denials for testing.” They described the benefits of CGP and precision testing, including:
- Improved treatment decisions (CGP treatment is tailored to patient’s specific cancer type.)
- Longer survival (Patients tested with CGP had a median overall survival of 15.7 months versus 7 months.)
- Reduced trial-and-error treatment (CGP includes markers like TMB (tumor mutational burden) and PD-L1, which help decide if immunotherapy is a good option.)
- Streamlined testing (Instead of running multiple separate tests, CGP combines everything into one, saving time and tissue samples.)
To combat the lack of access to precision treatments, the research team recommended a system-wide molecular tumor board to (i) provide a panel of precision medicine experts to assist with treatment decisions, and (ii) provide physician education through real-world examples of precision therapy treatments and associated outcomes.
Biomarker testing, treatment, and outcomes in patients with advanced / metastatic non-small cell lung cancer using a real-world database
Bhandari NR, et al. J Natl Compr Canc Netw. 2023
In this study, the authors compared overall survival rates by biomarker testing status and by receipt of guideline-recommended therapy in a large cohort of US patients with advanced or metastatic NSCLC. Despite recommendations from nationally recognized clinical guidelines, the overall rate of testing for actionable biomarkers was low. Of 21,572 patients studied, only 69% received testing for at least 1 actionable biomarker prior to or on initiation of first-line treatment, demonstrating opportunity for improvement.
Patients who received front-line biomarker testing and appropriate guideline-recommended therapy experienced significant improvements in overall survival rates compared with those who never received biomarker testing.
A global analysis of the value of precision medicine in oncology: the case of non-small cell lung cancer
Hofmarcher T, et al. Front Med (Lausanne). 2023
In this study, the authors assessed the value of biomarker testing and use of precision medicine for advanced NSCLC in multiple countries by comparing 1-year and 5-year survival model results of different testing scenarios:
- No biomarker testing (chemotherapy for all)
- Sequential testing (EGFR and ALK, followed by targeted therapy or chemotherapy)
- Next-generation sequencing (NGS) “multigene testing” (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET, and PD-L1, followed by targeted or immunotherapy)
Use of upfront biomarker testing led to an increase in patient survival rates when compared to no testing, with a near doubling of the progression-free disease phase with NGS, and a decrease in the number of treatment-related adverse events.
Improving biomarker testing in advanced non-small-cell lung cancer and metastatic colorectal cancer: experience from a large community oncology network in the USA
Schwartzberg L, et al. Future Oncol. 2023
In this study, the authors compared biomarker testing practices between OneOnc community oncology network and other nationwide sites. NGS testing rates were higher in the OneOnc network, reflecting the success of educational, pathway, and operational initiatives. Additionally, patients who received NGS testing had a greater likelihood of receiving targeted treatment than patients who received non-NGS testing (eg, fluorescence in situ hybridization, immunohistochemistry, or polymerase chain reaction testing) or individual biomarker testing (testing for each biomarker one at a time).
However, opportunities remain to optimize personalized healthcare by increasing NGS uptake, shortening turnaround times, and reducing the number of patients who start treatment before receiving complete biomarker test results.
Operational Improvements to Optimize Patient Care
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Programmatic Efforts Increase Adoption of Genomic Precision Medicine in Cancer Care in a Community Cancer Center
Darabi et al., JCO Precis Oncol. 2022
This research demonstrates that coordinated, programmatic initiatives in community cancer centers can significantly boost the adoption and clinical impact of genomic precision medicine, ultimately improving patient care.
A multidisciplinary team implemented a coordinated program to support the interpretation of genomic data, educate clinicians, and improve the use of somatic and germline genetic testing in cancer care to overcome barriers in adopting precision medicine, such as lack of clinician understanding, slow turnaround times, and insufficient DNA samples.
The most successful efforts included:
- Increased reflex testing protocols (from 661 in year one to 1532 in year three)
- In-house curation of genomic reports (provided deeper analysis beyond commercial lab reports and resulting in additional treatment or trial recommendations in 42.9% of cases)
- Educational seminars and tumor boards (increased physician understanding and confidence)
- Consultation services (requests for interpreting complex genomic data increased by 107.5%, indicating growing reliance and trust in precision medicine
Developing Consensus for a More Provider-Friendly Next-Generation Sequencing Molecular Biomarker Report
Gibson, et al., The Journal of Molecular Diagnostics. 2025
Currently, reports containing complex molecular biomarker results are often lengthy, inconsistent, and may be hard to interpret, which may lead to inefficiencies and underutilization of testing information and connecting it with treatment decisions. This article discusses the efforts of the Association for Molecular Pathology to examine best practices of and challenges with current reports to develop a template to optimally present biomarker results to oncologists, pathologists, and other healthcare providers, as well as patients. The developed template recommends:
- Standardizing nomenclature: Use consistent terminology, such as HGVS and HUGO standards, to describe genetic variants.
- Using tiered classification for variants: Use AMP/ASCO/CAP guidelines to categorize variants by their clinical significance.
- Clear communication of variant significance: Clearly state the relevance of each variant to diagnosis, prognosis, and therapy.
- Therapeutic implications and evidence levels: Include information about how each biomarker may impact treatment choices, supported by evidence.
- Providing essential report elements: Incorporate patient demographics, specimen details, assay description, biomarker results table, interpretation, pertinent negatives, and the therapeutic/diagnostic/prognostic significance.
- Using a provider-friendly format: Design the report to be concise, consistent, and easy for oncologists and other healthcare providers to interpret.
- Supporting evidence-based decisions: Ensure the report helps providers make accurate, evidence-based treatment decisions and reduces the risk of errors.
Adopting standardized, provider-friendly templates is critical for precision oncology, as it improves interpretation, reduces errors, and supports evidence-based treatment decisions. The next step is to ensure these templates and mock reports are widely available to all providers, ideally as free downloads, and to encourage consistent implementation across institutions.
Widespread Adoption of Precision Anticancer Therapies After Implementation of Pathologist-Directed Comprehensive Genomic Profiling Across a Large US Health System
Dowdell AK, et al. JCO Oncol Pract. 2024
In this study, the authors explored the impact of a pathologist-requested comprehensive genomic profiling (CGP) protocol on treatment selection and outcomes in 3,216 patients with advanced cancer across a large US health system. Utilizing a 523-gene panel at diagnosis, the protocol identified actionable biomarkers in 49% of patients. Compared to legacy 50-gene panels, CGP increased actionable mutation detection rates from 33% to 67%. Patients treated with biomarker-guided therapies demonstrated superior overall survival compared to those receiving chemotherapy alone (25 months vs 17 months).
The authors concluded that pathologist-directed CGP at diagnosis leads to broader adoption of precision therapies and improved patient outcomes, supporting a shift away from conventional chemotherapy as standard practice in advanced cancer care.
Total cost of testing for genomic alterations associated with next-generation sequencing versus polymerase chain reaction testing strategies among patients with metastatic non-small cell lung cancer
Vanderpoel J, et al. J Med Econ. 2022
In this study, researchers aimed to assess the total cost associated with next-generation sequencing versus polymerase chain reaction (PCR) testing strategies, which often involve analyzing single or pre-selected biomarkers that may not align with clinical guideline recommendations, among patients with metastatic NSCLC from a Medicare and Commercial payer perspective. Analysis was based on a hypothetical plan of 1 million patients insured through a blend of Medicare and commercial health plans.
NGS was associated with a shorter estimated mean time to initiation of appropriate targeted therapy compared to all other PCR strategies and resulted in the lowest per patient total cost of testing, demonstrating the clinical and economic value of adopting NGS for patients with metastatic NSCLC.
Pathologist-initiated reflex testing for biomarkers in non-small-cell lung cancer: expert consensus on the rationale and considerations for implementation
Gosney JR, et al. ESMO Open. 2023
In this publication, the authors provide an expert consensus review of the importance of implementing reflex testing in NSCLC, in which the responsibility for comprehensive molecular testing for an agreed range of biomarkers lies with the pathologist versus the treating oncologist.
The study’s authors demonstrate how reflex testing has been shown to standardize and expedite the process of ordering biomarker tests to ensure more patients are tested and provide considerations for defining reflex testing protocol, engaging with institutional stakeholders, and defining roles and responsibilities within the multi-disciplinary care team.
Interpreting and integrating genomic tests results in clinical cancer care: overview and practical guidance
Casolino R, et al. CA Cancer J Clin. 2024
In this review publication, the authors provide a primer on the use of precision medicine and opportunities for enhanced treatment through next-generation sequencing (NGS) testing in oncology. They assert that a lack of understanding of the clinical utility of NGS and difficulty of results interpretation by practicing oncologists result in decreased use of precision medicine in routine cancer care.
The authors present practical guidance for interpreting genomic test results to help inform clinical decision-making and discuss potential challenges to wider implementation of precision medicine into routine care.
Clinical utility of reflex ordered testing for molecular biomarkers in lung adenocarcinoma
Anand K, et al. Clin Lung Cancer. 2020
In this small, single-institution study, researchers evaluated the impact of standardized reflex molecular testing, in which the pathologist orders a group of pre-approved biomarkers at the time of initial diagnosis, for patients with newly diagnosed NSCLC. The authors reported that average turnaround time for test results was significantly reduced by 37 days with reflex testing and resulted in a higher variant detection rate than standard molecular biomarker ordering practices over a 2-year timeframe.
The authors identified adoption of reflex ordering practices by physicians across sites and utilization of the institution laboratory for analyses versus an unaffiliated laboratory as contributors to improved turnaround time for testing results.
Closing the testing gap: standardization of comprehensive biomarker testing for metastatic non-small-cell lung cancer in a large community oncology practice
Waterhouse DM, et al. JCO Oncol Pract. 2023
In this study, the authors evaluated the feasibility and impact of implementing a guideline-concordant comprehensive biomarker testing program for all newly diagnosed patients with metastatic NSCLC within a large community practice. The implementation process included provider education, initial electronic health record consult notes, and accompanying order sets, with further adjustments made after an initial evaluation trial.
The study authors reported a 1-year increase in testing rates from 68% to 92.7% and demonstrated the feasibility of a standardized workflow for comprehensive biomarker testing within a multisite community-based practice.
Providing Accessible and Equitable Biomarker Testing for NSCLC
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