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FDA approves Abbott AML detection kit

The US Food and Drug Administration (FDA) has granted a 510(k) approval to Abbott's Vysis EGR1 FISH Probe Kit to determine the prognosis of patients with acute myeloid leukemia (AML).

Vysis EGR1 FISH Probe Kit detects deletion of LSI EGR1 probe target on chromosome 5q in bone marrow specimens at the time of AML diagnosis as an aid in determining prognosis.

Abbott’s molecular diagnostics business head Stafford O’Kelly said the company’s Vysis EGR1 FISH Probe Kit can identify which AML patients have the chromosomal abnormality upon diagnosis and provides physicians with another clinically validated tool to assess a patient’s overall prognosis.