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Institute Report
Optimizing Oncology Care Through Biomarker Adoption
Barriers and Solutions
Sep 09, 2020
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About the Report

Improvements in oncology care are being driven by the growing availability and use of biomarker testing. Such tests influence health outcomes by informing care teams whether a specific targeted therapy is likely to be effective for a specific patient. However, in routine care, levels of biomarker testing differ greatly across tumor types and by biomarker, with varying adherence to testing guidelines. This report discusses the major barriers that limit testing for solid tumor biomarkers in the United States and how they are evolving within a changing healthcare landscape. It further offers solutions to help reduce these testing barriers in oncology and ensure treatment benefits are fully realized.

Report Summary

An increased understanding of genetic and other molecular alterations in solid tumors — along with the development of targeted biomarker-based treatments for cancers with such alterations — have led to major improvements in patient care, overall survival, and quality of life outcomes. As such, biomarker testing has emerged as an important part of cancer care. However, there are several barriers to oncology biomarker testing for solid tumors including suboptimal tissue procurement and triaging; challenges with continuity of care across institutions; fragmented insurance coverage and inadequate reimbursement of testing; fragmented testing guidelines; and low awareness of actionable biomarkers by stakeholders. These result in operational inefficiencies in biomarker testing, limit awareness of available tests, and disincentivize broad and optimal use of testing. Collaboration across multiple stakeholders will be required to bring about a future with better patient outcomes through more robust diagnostic testing in cancer, and this report profiles potential solutions to help reduce testing barriers.

Key Findings

Optimal adoption of biomarker testing is necessary for cancer patients to reap the benefits of biomarker-based targeted therapies, yet testing rates vary greatly across biomarkers and tumor types.

Variability in Oncology Biomarker Testing Rates
  • Within just a few months after the launch of the first BRAF-targeted treatment for melanoma, nearly 90% of patients who were potentially eligible for an associated treatment for metastatic melanoma were tested. However, many other biomarkers such as EGFR and ALK for NSCLC saw a much slower increase in testing after the first associated product came to market.
  • While the use of biomarker testing is on the rise, slow and uneven adoption of biomarker testing can result in patients not receiving optimal treatments, potentially resulting in diminished patient outcomes and reduced survival.
  • Poor testing rates represent a major hurdle in getting the right medicine to the right patient at the right time. Patients cannot fully realize the benefits of the precision medicine revolution in oncology without adequate biomarker testing to inform treatment decision-making.


As biomarker tests and biomarker-based medicines proliferate, the complexity of the patient journey has increased, and a number of barriers hinder optimal use of testing to guide therapy selection.

Barriers to the Use of Biomarker Tests Throughout the Patient Journey
  • Suboptimal tissue procurement and triaging are significant clinical and technical barriers to tumor biomarker testing, and healthcare providers cite insufficient quantity of biopsy material as a key challenge to testing.
  • Fragmented coverage of biomarker tests by payers can be a hurdle to optimal testing, particularly given the emergence of next-generation sequencing (NGS) technology and the simultaneous testing of multiple biomarkers via panels — both of which may be poorly covered.
  • As the oncology treatment landscape becomes more crowded with predictive biomarker-based therapies within overlapping patient populations, fragmented testing guidelines compound challenges in treatment decision-making.


With an ever-growing focus on personalized medicine, changes that address testing barriers and spur a robust uptake of biomarker testing in oncology care can enable a future with better patient outcomes.

Recommendations to Overcome Barriers to Biomarker Testing
  • In order to optimize biomarker testing in oncology, systems need to be in place to guide the efficient extraction, triaging, and handling of tumor tissue to support testing.
  • Payer reimbursement policies may need to evolve to determine when coverage of a multigene panel test should occur in place of single, targeted genetic test to ensure patients don’t shoulder the burden of high out-of-pocket costs.
  • There is a need to better integrate both treatment and biomarker testing recommendations into the same guidelines to understand whom to test, when to test, which biomarkers should be tested for, and how best to test for them. Updating guidelines will require input and collaboration across a range of experts, including both oncologists and pathologists, among others.

Optimizing Oncology Care Through Biomarker Adoption

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