The American Society of Hematology (ASH) submitted comments to the FDA supporting the agency’s draft guidance for next-generation sequencing (NGS)-based tests for germline diseases. ASH’s comments ask for clarification and make suggestions for other recommendations to be included in the final guidance so that NGS-based tests can be effectively designed, developed, and validated for various hematologic diseases.
ASH suggested that the FDA:
- clarify its review and approval of NGS-based tests for germline diseases
- include its regulation of other types of NGS-based tests (e.g., tumor genome sequencing) that are valuable for the identification of structural genetic alterations
- address variant interpretation
- develop a complementary guidance for somatic diseases
“ASH commends the FDA for developing recommendations that will foster the effective design, development, and validation of NGS-based tests for hematologic malignancies,” wrote ASH President Charles S. Abrams, MD, in the recommendation letter. “These recommendations would facilitate the improvement in overall quality control of testing laboratories, improve the tests’ clinical benefits, and, more importantly, advance diagnosis and treatment outcomes.”
The recommendations were developed with input from various committee members and built on previous comments that ASH has submitted on this topic.
Source: American Society of Hematology press release, September 29, 2016.