Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Food and Drug Administration

ASH represents more than 15,000 hematologists who are committed to the treatment of blood and blood-related diseases. These diseases include anemias (such as sickle cell disease and thalassemia), thrombosis and bleeding disorders, as well as malignant hematologic disorders such as leukemia, lymphoma, and myeloma. ASH members include clinicians who order Next Generation Sequencing (NGS) diagnostic tests for their patients, as well as laboratory based hematologists and pathologists who develop, perform and interpret these tests. NGS testing is a broad, complex, and rapidly evolving area which has the potential to greatly impact diagnostics and therapies in clinical practice. Many malignant and non-malignant hematologic conditions are being studied by genomic analyses, and the field needs harmonized approaches for diagnostics and sequencing. Thus, the Society’s members have a vested interest in this draft guidance, its potential impact on patient care and future access to possibly life-saving diagnostic testing for patients with hematologic conditions.