Biomarker Testing Transforms NSCLC Care, But Gaps Persist in Community Settings

Lung cancer is the second most common cancer in both men and women in the United States and is the leading cause of death, affecting 1 in 5 patients. Non–small cell lung cancer (NSCLC) is the most common and aggressive type of lung cancer that accounts for 85% of all diagnoses.

According to the American Cancer Society, more people die of lung cancer than of colon, breast, and prostate cancers combined each year. Despite poor prognoses, the introduction of biomarker testing has significantly improved treatment outcomes for patients with early or advanced stage disease. In a session at the Community Oncology Alliance (COA) 2025 Community Oncology Conference, experts discussed the substantial impact of biomarker testing in guiding treatment decisions for patients with NSCLC.

Next-generation sequencing | Image Credit: © Supaporn - stock.adobe.com

“It was a pretty dismal prognosis to be diagnosed with late stage [NSCLC] a decade ago, but in the past few years, biomarker directive therapy has really changed everything we're able for both early stage and advanced stage,” said Alia Lynch, PharmD, BCOP, ambulatory clinical pharmacist at UVA Health in Charlottesville, Virginia, during the COA session. “Targeting genetic mutations can change the course of treatment for these patients, and we're seeing better survival, which further underscores the outcomes for these patients.”

What Are Biomarkers?

Biomarkers are biological molecules found in blood, bodily fluids, or tissues that indicate normal or abnormal processes. In NSCLC, biomarkers can be predictive or prognostic. Predictive biomarkers such as EGFR mutations, ALK rearrangements, and ROS1 fusions can be targeted with specific therapies. In contrast, prognostic biomarkers only indicate disease aggressiveness.

Biomarker testing has revolutionized treatment across cancer types and disease stages, personalizing cancer treatment by understanding the specific genetic alterations driving a patient's individual disease. Biomarker testing can help pharmacists and other health care providers select the most appropriate treatment for patients, improve survival, identify potential clinical trial opportunities, and potentially avoid ineffective treatments. There are various available testing methods which include single gene tests, immunohistochemistry (IHC), next-generation sequencing (NGS), and liquid biopsies.

Which Is Better: Single-Gene or NGS?

With various testing options available, its critical for health care providers to understand the advantages or disadvantages of specific biomarker screening relative to each patient they treat. Single gene testing has multiple benefits for patients, including its quicker result turnaround and cheaper costs, making it more accessible for many. It is good for initial or targeted screening but only tests for one specific mutation at a time and lacks the comprehensiveness of other tests, offering a more limited scope of information. This led to the introduction of NGS, a novel advancement in biomarker screening.

Unlike single-gene testing, NGS consists of the massive parallel sequencing of multiple genes simultaneously to detect mutations, fusions, and copy number alterations. There are 2 types of NGS tests, DNA-based and RNA-based, which can be performed on tissue or liquid biopsies. NGS has revolutionized biomarker testing by generating a more comprehensive view of genetic landscape and is better at detecting complex mutations and fusions. Additionally, results from NGS can help guide precision medicine approaches and pave the way for more treatment or clinical trial options. As a result, guidelines prefer NGS as initial screening for patients with NSCLC.

“Patient biomarker testing will open the doors for patients to participate in clinical trials as their disease progresses,” said Lynch. “If we do NGS and identify mutations that may not currently be targetable—so they may be prognostic but not predictive—a clinical trial could open up when the patients failed on the standard therapies, and they may be able to go on that trial and try a new therapy that could extend their lives.”

What Are the Guideline Recommendations for Biomarker Testing in NSCLC?

There is a continued move towards comprehensive, early-stage biomarker testing, which is key to maximizing treatment precision and patient outcomes, as is recommended by the 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) joint guideline and the National Comprehensive Cancer Network (NCCN) 2025 guidelines, which expand on the 2018 ASCO/CAP recommendations.

The ASCO/CAP guideline recommends molecular testing for all patients with advanced non-squamous NSCLC, as well as for some with advanced squamous cell carcinoma; however, this is typically specific to those who never smoked and are younger as these patients are more likely to have genomic mutations. The NCCN guidelines agree with many of the recommendations made by the ASCO/CAP guidelines, including testing all patients with advanced non-squamous lung cancer, with a preference for comprehensive NGS panels. The guidelines also highlight PD-L1 IHC testing on all patients, as well as testing for early-stage disease.

What Does Biomarker Testing Look Like in Community Settings?

Comprehensive and proactive biomarker testing is critical in both academic and community settings, but there can be barriers to implementation within community settings. According to Melody Chang, RPH, MBA, BCOP, vice president of Pharmacy Operations for the American Oncology Network, biomarker testing rates in community settings often do not meet the guideline recommendations, which is often a result of limited resource access. In patients with NSCLC in community settings, 83% had at least 1 biomarker tested; however, only 37% had all 9 recommended biomarkers tested. Only 35.9% of patients with positive biomarker mutations received indicated therapy and 10.1% received treatments not approved for their specific mutation.

Community oncology practices face several key barriers to effective biomarker testing in non–small cell lung cancer (NSCLC). These include the frequent issue of insufficient tissue samples, delays in interpreting test results, and difficulties in implementing comprehensive testing strategies. Such challenges can limit the ability to identify actionable mutations and ultimately delay or prevent patients from receiving the most appropriate targeted therapies.

To address these barriers, several practical solutions are being explored. One approach is to implement a reflex dual specimen pathway, which involves collecting both tissue and liquid biopsy samples at the time of diagnosis to increase the likelihood of obtaining adequate material for testing. Enhancing the speed and efficiency of test result interpretation is also critical to ensuring timely clinical decision-making. Ultimately, these efforts aim to improve the selection of appropriate treatments based on each patient’s unique biomarker profile, helping to optimize outcomes in NSCLC care.

“The main message here is testing isn't just about following the guidelines, it directly impacts the patient's survival outcome,” said Chang during the COA session. “So that's what I think we're not only asking for timely testing, but we’re also asking for the timely interpretation as well as the timely action.”

What Is the Role of Oncology Pharmacists?

Pharmacists are well-suited for these roles because they are experts in medicines, understand resistance patterns, and are trained to pay attention to critical clinical details. Despite traditionally limited training in pharmacogenomics, with proper support, pharmacists can significantly contribute to precision care by helping select targeted therapies and improving patient outcomes.

In both community and academic medical settings, pharmacists play a critical role in supporting reflex NGS order sets. They can lead updates to clinical pathways as new biomarkers and therapies emerge, flag actionable mutations, and help interpret complex genomic reports. Additionally, pharmacists assist with prior authorizations, track testing metrics to monitor performance, and facilitate multidisciplinary collaboration by coordinating virtual tumor boards, ensuring that biomarker testing is integrated effectively into patient care.

“Pharmacists can play a big role in precision care moving forward,” explained Chang during the COA session. “Why? Because we’re the experts of medicines. We know resistance patterns, drug reactions, and are trained to pay attention to critical clinical details. That's exactly what's needed when interpreting the complex genomic report, right? And we're also system thinkers, from managing the prior authorizations to navigating the insurance hurdles and to helping operationalize the workflow.”

As health care systems continue to embrace personalized medicine, integrating biomarker testing into routine practice requires a multidisciplinary effort—and pharmacists are emerging as vital players in this process. Their expertise in therapeutics, operational workflows, and data interpretation makes them uniquely positioned to help optimize testing strategies and ensure timely treatment decisions. By bridging clinical insights with practical implementation, pharmacists support a more streamlined, patient-centered approach to care. This growing emphasis on collaboration and precision underscores a broader shift across oncology care settings—one that aligns with national efforts to improve access, equity, and outcomes through biomarker-driven treatment.

“COA believes biomarker testing to be essential as a tool in prescribing the most appropriate cancer treatment,” said COA in an official statement. “Biomarker testing is pivotal in modern medicine; personalizing cancer treatment testing helps identify specific biological markers in a patient's tumor, guidance selection of most effective therapies. By ensuring that patients receive proper chemotherapy, biologic or biosimilar treatment, biomarker testing improves outcomes, it supports broader access to life saving medications, making advanced care more affordable and equitable, and sparing patients from potential toxicities of ineffective treatments.”

REFERENCES

Chang M, Lynch A. Aiming for accuracy in non-small cell lung cancer treatment: precision strategies for oncology pharmacists. Community Oncology Alliance 2025 Community Oncology Conference. April 28, 2025, to April 30, 2025. Orlando, FL