ASCO submitted comments to the U.S. Food and Drug Administration (FDA) on its white paper, “Optimizing FDA’s Regulatory Oversight of Next-Generation Sequencing Diagnostic Tests.” The Society expressed its support of the exploration of new regulatory strategies for next-generation sequencing diagnostic tests (given the tests’ potential to identify individuals at high risk for developing cancer), and to support clinical decisions for those already diagnosed.
In the comments letter, ASCO stated its support for a standards-based approach to regulatory review of next-generation sequencing tests that would not only ensure continued quality, but would also validate the tests for analytic performance. Although ASCO strongly recommended that regulation be implemented in such a manner as to ensure ongoing innovation in the field of molecular diagnostics development, as well as timely patient access to the new generation of molecular and genomic tests that can improve care, the Society recognized the harm failed tests can cause patients by recommending them for inappropriate, and potentially harmful, treatment.
Similarly, ASCO warned against misinterpretation or overinterpretation of test results, both of which could potentially mislead physicians and expose patients to undue risk. Consequently, ASCO urged the FDA to establish guidelines regarding how next-generation sequencing test results are reported, to ensure that results are clear and easily interpretable.
Read the full letter at www.asco.org/sites/www.asco.org/files/asco_ngs_comments_03.20.2015.pdf. ■
© 2015. American Society of Clinical Oncology. All rights reserved.