LUNGevity’s Precision Medicine Initiatives take a holistic approach to advancing the adoption and increasing awareness of comprehensive biomarker testing for people with non-small cell lung cancer (NSCLC). These programs are designed to ensure that all patients have timely access to appropriate tests and that treatment decisions are based on the outcome of those tests, regardless of where they receive care.
We achieve this through collaborative efforts aimed at identifying barriers and developing practical solutions that enhance biomarker testing awareness and implementation in hospitals and healthcare systems.
Since 2023, a multi-stakeholder working group on reflex biomarker testing has convened to study barriers, variation, and opportunities to optimize biomarker testing at the point of diagnosis, ensuring it is ordered as soon as a NSCLC diagnosis is made. Prior work has produced a landscape overview of HCP perspectives on the role of pathologists in ordering multi-gene biomarker panels, a solutions roadmap describing approaches healthcare systems are using to enable timely testing, and an analysis of the impact of the CMS 14-day rule on biomarker testing timelines in cancer care. Our current phase is focused on implementation, policy change, and system-level adoption.
- 14-Day Rule Reform
This group focuses on updating CMS inpatient and outpatient policies to better support timely reflex biomarker testing and reduce delays in diagnosis and treatment decisions. Advocacy efforts include engagement in inpatient rulemaking to modernize regulatory constraints that limit testing efficiency.
- Healthcare System Implementation
Purpose:
This group focuses on enabling all patients with NSCLC to receive biomarker-informed treatment decisions through consistent reflex testing workflows within health systems. Efforts center on identifying institutional decision-makers, aligning testing protocols with operational priorities, and supporting workflow change through consensus building, implementation support, and measurable quality improvement.
Implementation and education efforts will be informed by findings from the Solutions Roadmap study (manuscript in development).
- Society Collaboration
Purpose:
This group works with professional societies and clinical stakeholders to share approaches for improving timely biomarker testing in NSCLC across organizations. The goal is to support alignment across societies on education and initiatives related to reflex biomarker testing, ensuring consistent messaging and shared priorities for provider members. We welcome the participation of additional societies looking to partner and learn from each other.
- Payers and Coverage
Purpose:
This group focuses on improving insurance coverage and reducing financial barriers to comprehensive NSCLC biomarker testing. Activities include supporting state-level legislation and ACS CAN efforts to engage Medicaid programs, as well as new collaborations with AMCP and ACS CAN to better understand payer and laboratory benefit manager perspectives on coverage policies.
A key focus is gathering payer viewpoints on current guidelines and on how policies such as the CMS 14-day rule are being applied in commercial populations, which can impact timely biomarker testing at diagnosis. The goal is to identify coverage-related barriers and opportunities to support more consistent and timely access to testing.
- Data Gathering
Purpose:
This group is responsible for generating cross-stakeholder evidence on the clinical and system value of earlier and more comprehensive biomarker testing, and for supporting submission of findings to guideline committees and CMS to inform broader recommendations on testing and coverage in early-stage disease.
- Terminology Definition
Purpose:
This group works to standardize terminology and definitions (including “reflex testing”) to ensure consistency across clinicians, laboratories, payers, and policymakers.
The Tissue Acquisition and Preanalytics Working Group is focused on understanding how variation in biopsy, specimen handling, and laboratory processes contributes to tissue inadequacy for biomarker testing. The goal is to identify actionable opportunities to improve tissue quality, strengthen feedback loops, and inform future development of workflows, playbooks, and potential quality measures. Previous work in this area can be found here. We are building on this foundation to support implementation and system-level improvement.
The No One Missed program, led by LUNGevity Foundation in collaboration with over 25 organizations, aims to drive awareness and adoption of comprehensive biomarker testing across cancer types. This campaign empowers patients to advocate for testing as a vital step in achieving a fully informed diagnosis and optimal care.
LUNGevity hosts an annual Lung Cancer Precision Medicine Summit where experts, professional societies, patient advocacy groups, and industry partners come together to discuss advancements in precision medicine, identify emerging trends, and celebrate progress.
Read a summary of the most recent summit.
Cancer Precision Medicine Commons
The Cancer Precision Medicine Commons is a cross-cancer consortium of patient advocacy groups and professional societies that LUNGevity convenes to share best practices and collaborate on opportunities to improve the delivery of precision medicine for all people with cancer.
For more information about these programs, please contact Nikki Martin, Senior Director of Precision Medicine Initiatives, at [email protected].
- Medicare Policy for Genomic Test Orders: Resources that Describe CMS Policy. Bruce Quinn Associates. January 2025.
- Fintelmann FJ, Martin NA, Tahir I, et al. Optimizing molecular testing of lung cancer needle biopsy specimens: potential solutions from an interdisciplinary qualitative study. Respir Res. 2023;24:17. doi.org/10.1186/s12931-023-02321-9.
- Understanding the Patient Experience With Biomarker Testing Results Reports in Lung Cancer. June 2022.
- Martin N, Dropkin L, Redway L, et al. Patient perceptions of biomarker testing. Oncol Issues. 2022;37:58-62. PDF
- Martin NA, Tepper JE, Giri VN, et al. Adopting consensus terms for testing in precision medicine. JCO Precis Oncol. 2021;5. doi.org/10.1200/PO.21.00027.
- Inconsistencies Within Biomarker Test Reports Provide Opportunities for Future Patient Education. September 2021.
- Biomarker Results Report Harmonization White Paper. June 2021.
- A White Paper on the Need for Consistent Terms for Testing in Precision Medicine. September 2020.
- Payer Coverage Policies of Tumor Biomarker Testing. September 2020.
