Abbott’s Diagnostic Test for AML Prognosis Cleared by FDA

Abbott has announced that it has received FDA clearance for a new in vitro diagnostic test for predicting the prognosis of Acute Myeloid Leukaemia (AML) patients.

AML is one of the most common types of adult leukaemia and is characterized by fast growing abnormal white blood cells in the bone marrow. These abnormal cells replace the patients normally functioning white blood cells impairing the normal immune response. Eventually, the bone marrow is unable to function properly, leaving patients infection-prone and at risk of bleeding. AML can progress rapidly and patients are treated aggressively with chemotherapy. Some patients may also require a stem-cell transplant to replace unhealthy bone marrow with leukaemia-free stem cells.

Abbott's Vysis EGR1 FISH Probe Kit, the third Abbott FISH assay approved or cleared in the past two 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.

"Abbott'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," said Stafford O'Kelly, head of Abbott's molecular diagnostics business.

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.