FDA clears Abbott AML diagnostic test

The US Food and Drug Administration (FDA) has granted approval for an in vitro diagnostic test to determine the prognosis of patients with acute myeloid leukaemia (AML).

The new test, developed by Abbott and based on the company’s Vysis EGR1 fluorescence in-situ hybridisation technology, detects a chromosomal deletion in bone marrow that is associated with an unfavourable prognosis for AML patients.

The kit detects deletion of LSI EGR1 probe target on chromosome 5q in bone marrow specimens.

Abbott molecular diagnostics business head Stafford O’Kelly said that the kit can detect which AML patients have the chromosomal abnormality and provide physicians with a validated tool to assess a patient’s overall prognosis.