FDA Classifies DNA-Based Test for Hematological Malignancies to Class II
May 09, 2025
May 09, 2025
WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has classified a DNA-based test to measure minimal residual disease in hematological malignancies as a class II device under special controls.
The classification, which was finalized on May 9, 2025, follows a review of the request submitted by Adaptive Biotechnologies Corporation for the clonoSEQ Assay, a test used to detect and quantify specific nucleic acid sequences i . . .
The classification, which was finalized on May 9, 2025, follows a review of the request submitted by Adaptive Biotechnologies Corporation for the clonoSEQ Assay, a test used to detect and quantify specific nucleic acid sequences i . . .