Abbott’s genetic test for acute myeloid leukemia prognosis cleared by FDA

Abbott (NYSE: ABT) announced today it has received 510(k) clearance from the U.S. Food and Drug Administration 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.

“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.

Technical Information on the EGR1 FISH Assay

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 acute myeloid leukemia (AML) diagnosis as an aid in determining prognosis. Deletion of chromosome 5q has been associated with an unfavorable prognosis in AML patients.

About FISH

FISH (fluorescence in-situ hybridization) technology has a variety of uses.

It can identify whether too many, or too few, copies of a particular gene are present in the body’s cells or whether certain genes have rearrangements that play an active role in disease progression. Cancer diagnostics is one of the fastest growing applications.

The Vysis EGR1 FISH Probe Kit is the latest addition to Abbott Molecular’s growing list of FISH-based in vitro diagnostic products available in the U.S. In August, the agency cleared Abbott’s Vysis CLL FISH Probe Kit and approved the Abbott Vysis ALK Break Apart FISH Probe Kit. Abbott also offers FISH-based tests for breast and bladder cancer.