Test for AML Prognosis Cleared by FDA


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FDAlogoAbbott announced today it has received 510(k) clearance from the FDA for a new in vitro diagnostic test to aid in determining the prognosis of patients with acute myeloid leukemia (AML) Abbott’s Vysis EGR1 FISH Probe Kit, the third Abbott fluorescence in situ hybridization (FISH) assay approved or cleared in the past 2 months by the FDA for oncology applications, detects a chromosomal deletion in bone marrow that is usually associated with an unfavorable prognosis for AML patients.

Published reports from several large clinical studies and the National Comprehensive Cancer Network guidelines suggest that chromosomal abnormalities associated with AML are valuable prognostic indicators. One study, conducted as part of an Eastern Cooperative Oncology Group (ECOG) clinical trial, demonstrated the utility of FISH technology to separate AML patients into risk categories based on chromosomal status or changes. Based on these categories, physicians are able to establish an effective disease management approach.

The Vysis EGR1 FISH Probe Kit is intended to detect deletion of LSI EGR1 probe target on chromosome 5q in bone marrow specimens and may be used, in addition to cytogenetics, other biomarkers, morphology and other clinical information, at the time of AML diagnosis as an aid in determining prognosis. Deletion of chromosome 5q has been associated with an unfavorable prognosis in AML patients. ■



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