Abbott has received 510(k) clearance from the US Food and Drug Administration (FDA) for a new in vitro diagnostic test to aid in determining the prognosis of patients with acute myeloid leukemia (AML), one of the most common types of leukemia in older adults.
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. In AML, fast-growing abnormal white blood cells in bone marrow replace healthy cells and impede the body’s ability to fight infection. Eventually, the bone marrow ceases to function properly, leaving patients infection-prone and at risk for bleeding. More than 12,000 people are diagnosed with AML each year. Because acute leukemia may rapidly progress, most AML patients are treated aggressively with chemotherapy drugs. Some patients may require a stem-cell transplant to replace unhealthy bone marrow with leukemia-free stem cells.
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.