Biomarker Testing in Oncology

A biomarker is a characteristic that can be scientifically measured or evaluated as an indicator of normal biologic processes, disease, or response to therapeutic intervention. The major types of biomarkers include molecular, histologic, radiographic, and physiologic characteristics. Examples of biomarkers include blood pressure, blood glucose levels, and imaging results. As the field of precision medicine grows, the focus on genetic biomarkers has grown as well. The following sections will focus on biomarker testing in oncology.

Biomarker testing (also known as mutation, genomic, or molecular testing) uses laboratory tests to help the health care team gather as much information as possible about a patient’s cancer and uncover whether the patient has an actionable mutation. Four categories of biomarker testing include: predisposition, diagnostic, prognostic, and predictive:

A companion diagnostic (CDx) is typically an in vitro diagnostic that detects a predictive biomarker to determine the likely efficacy and safety of a corresponding drug or biological product. For example, FoundationOne^® CDx is an FDA-approved, tissue-based broad CDx that physicians can use to analyze the genomic profile of individual patient’s tumors. Results may help inform treatment decisions for over 20 FDA-approved targeted therapies. Clinicians should order the corresponding CDx to determine appropriate therapeutic options for each patient.

Biomarker testing can help providers make more informed treatment decisions based on a patient’s genomic makeup or the genomic makeup of their cancer. Additionally, biomarker testing can align with a health system’s broader strategic goals. For example, with the shift to value-based care, many organizations are focused on delivering appropriate, high-value care. Additionally, many organizations are focused on expanding their precision medicine programs to provide patients with more informed, personalized care. Biomarker testing aligns with each of these system-level strategic priorities.

Given the advantages of biomarker testing, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) recommend assessment of biomarker test results prior to treatment initiation in eligible patients with metastatic non-small cell lung cancer (mNSCLC). As a result, biomarker testing is essential to provide guideline-concordant care in many areas of oncology

Despite these benefits, gaps still exist in realizing the full potential of biomarker testing. Many patients who are eligible for biomarker testing do not receive guideline recommended testing. Of patients who do receive biomarker testing, many eligible patients do not receive targeted therapy due to challenges throughout the process (e.g., insufficient tissue, long turnaround times that prevent clinicians from using results to help inform treatment decisions, complicated or inaccessible test reports).

No two patient journeys look the same—especially in cancer care. However, the biomarker testing process does follow a general order of operations:

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