Cancer genomic testing, including analysis of tumor tissue and circulating tumor DNA, is becoming a key element of cancer care for several tumor types. These tests are used to assess cancer risk, inform prognosis, and detect disease recurrence, as well as to inform treatment decisions for certain cancers. There are 27 molecular biomarkers that guide therapy selection with more than 40 US Food and Drug Administration (FDA)-approved drugs, and several of these molecularly targeted therapies have companion diagnostic tests approved by the FDA. These tests, including next-generation sequencing (NGS) profiling, are covered by Medicare and Medicaid in the US for appropriate patients, and are recommended by major medical professional societies. For example, the European Society for Medical Oncology recommends appropriate clinical use of NGS testing for patients with metastatic cancers, and the American Society of Clinical Oncology recommends multigene panel testing in patients with advanced solid tumors whenever more than 1 genomic biomarker has been linked to an approved therapy. Despite all of this support and evidence, physician surveys and electronic health record (EHR) data indicate that cancer genomic testing is underutilized.
In a New England Journal of Medicine Perspective article, Richard Schilsky, MD, and Dan Longo, MD, identified challenges across the patient workflow that contribute to the gap in cancer genomic testing, and proposed some potential remedies. Some of the key challenges are: uncertainty among oncologists as to which tests to order, prolonged turnaround time for results, difficulty interpreting test results, lack of clarity as to the level of evidence supporting selection of a potential treatment, difficulty obtaining access to investigational or off-label use of treatments, and challenges with data collection regarding patient outcomes. Potential remedies include: incorporation of evidence-based biomarker testing into EHR and quality measures, shortening turnaround time for testing labs, a universal public database for annotation of cancer genomic alterations (with actionable information), molecular tumor board reviews, clinical trial-matching software, guideline and standards development by professional societies, premarketing and expanded access programs, and simplified EHR data collection.
The authors concluded that equitable and efficient delivery of precision cancer care is a global effort that requires patient access to validated molecular tests, consistent regulatory and reimbursement support, and collaboration between practice and health system leaders to develop the information infrastructure and multidisciplinary workforce necessary to support this approach.
Dr Schilsky and Dr Longo suggested several strategies health systems can use to help bridge the gap in cancer genomic testing, such as system-wide workflows that automatically trigger NGS testing for advanced solid tumors, utilization of tumor boards, and support for clinical trial matching and prior authorizations. With a comprehensive information infrastructure, outcomes can be captured in EHRs to help identify gaps in care.
At the practice level, implementation of practice-wide workflows that automatically trigger cancer genomic testing for appropriate patients and use of molecular tumor boards can help improve identification of patients who may benefit from precision cancer medicines and/or potential clinical trial participation. Educational programs and testing algorithms may help to increase providers’ confidence in ordering genomic tests and understanding the implications of the results.