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# FDA Approves Asuragen Test for Monitoring Leukemia Treatment
- URL: https://www.fdaweb.com/fda-approves-asuragen-test-for-monitoring-leukemia-treatment/
- Published: 2016-07-22T12:00:00.000Z
- Updated: 2026-09-14T21:16:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136260

FDA has approved an Asuragen de novo submission to allow marketing of the QuantideX qPCR BCR-ABL IS Kit, the first nucleic acid-based quantitation test for use during treatment of chronic myeloid leukemia (CML) patients. The device uses blood specimens from patients with CML to measure the amount of BCR-ABL fusion genes, which can be used to estimate the amount of leukemia cells in a patient when treated with BCR-ABL targeted therapies. “The clinical performance of the QuantideX qPCR BCR-ABL IS Kit was evaluated by a study using banked samples across three U.S. clinical laboratories from 98 patients,” an agency release says. “Study results demonstrated a significant difference in the outcomes of patients who achieved reduced levels of BCR-ABL from targeted therapy from those who did not.”