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Home » Minimal Residual Disease Assay for Leukemia Patients Cleared by FDA
Minimal Residual Disease Assay for Leukemia Patients Cleared by FDA
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The FDA granted 510(k) clearance to Adaptive Biotechnologies’ vitro diagnostic, which tests for minimal residual disease in patients with B-cell ALL or multiple myeloma.
The next-generation sequencing assay, ClonoSEQ, requires a minimum DNA sample of 500 nanograms.
The assay tests for minimal residual disease by identifying and counting gene sequences in DNA extracted from the patient’s bone marrow.
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