The Cancer Prevention and Ethics Committees of the American Society of Clinical Oncology have made several recommendations that address genetic and genomic testing policies for cancer risk assessment.
While the technology driving the development of newer genetic tests and multigene panels has gained rapid strides, providers struggle with knowledge gaps and assurance of test validity. Recognizing these and other issues is a policy statement that was released by the American Society of Clinical Oncology (ASCO); the updated recommendations by ASCO were published in the Journal of Clinical Oncology.
Albeit the significant advantage that genetic testing panels bring to oncology care, the field remains a work-in-progress. Providers and payers continue to question the clinical validity and utility of diagnostic tests. Oncologists constantly struggle when determining the “value” of gene tests considering the high costs associated with some of the panels.
With the new recommendations, ASCO wants to ensure optimal deployment of current and future innovative gene technologies in clinical practice. ASCO president Julie M Vose, MD, MBA, FASCO, said in a statement, “As cancer diagnosis and treatment is becoming more genetically-driven, new opportunities and questions are emerging about screening for hereditary cancers. ASCO is releasing this updated policy statement at this critical juncture to ensure that all interested parties thoughtfully consider these concerns as the future of genetic and genomic testing for cancer susceptibility unfolds.”
ASCO’s Cancer Prevention and Ethics Committees have 5 key recommendations in the policy update:
1. Germ-line Implications of Somatic Mutation Profiling.
ASCO recommends additional research to generate best practices for providing patients with incidental and secondary germ-line information. Additionally, the Society has stressed the need for knowledge gain on patient preferences, optimal pre-test education and informed consent, and multilevel outcomes (ie, patient, provider, healthcare system delivery, and cost). If patients choose not to receive germ-line findings, ASCO recommends that testing laboratories should have protocols to report only the somatic mutational data.
2. Multigene Panel Testing for Cancer Susceptibility
Recognizing the level of detailed information that multigene panels provide, ASCO acknowledges that these tests may provide information on variants of uncertain significance. Due to existing knowledge gaps, ASCO recommends that providers with particular expertise in cancer risk assessment should be involved in the ordering and interpretation of multigene panels that include genes of uncertain clinical utility and genes not suggested by the patient's personal and/or family history. Development of evidence-based guidelines for optimal use of these multigene panels and provider education are also encouraged.
3. Quality Assurance in Genetic Testing
Emphasizing the need for risk-based FDA regulation of laboratory-developed tests as well as commercial diagnostic tests, ASCO underscores the importance of innovation and patient access for these tests.
4. Education for Oncology Professionals
ASCO recommends that healthcare providers involved in cancer risk assessment should participate in oncology training programs and continued education programs. New trainees should receive adequate training to be able to achieve necessary risk-assessment skills.
5. Access to Cancer Genetic Services
Coverage policies can ensure patient access to these innovative cancer risk-assessment tools, and ASCO has called for coverage assurance for individuals who are suspected to be at increased genetic risk. Additionally, ASCO opposes payment policies that could potentially negatively impact the care of patients with cancer by serving as barriers to the appropriate use of genetic testing services.