Vysis EGR1 FISH Probe Kit Assay Approved for AML Patients

Abbott announced that its Vysis EGR1 FISH Probe Kit has received 501K clearance from the FDA to detect a chromosomal deletion in bone marrow that is usually associated with an unfavorable prognosis for acute myeloid leukemia (AML) patients. 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.

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