Next Gen Sequencing: ASCO Supports FDA Initiative

While supporting the FDA's standards-based regulatory efforts to explore next generation sequencing tests as diagnostic tools, the American Society of Clinical Oncology warned against misinterpretation or over-interpretation of test results.

The American Society of Clinical Oncology (ASCO) has submitted comments to the 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 (NGS) 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 letter, ASCO stated its support for a standards-based approach to regulatory review of NGS 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.

Link to the news on ASCO's website:

Link to the letter submitted to the FDA: