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FDA Clears Abbott's AML Prognosis Assay

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has granted 510(k) clearance for Abbott's FISH-based prognostic test for use on patients with acute myeloid leukemia, the company announced today.

Abbott's Vysis EGR1 FISH Probe Kit is for detecting deletion of an LSI EGR1 probe target on chromosome 5q in bone marrow specimens and may be used as an aid in determining a patient's prognosis, in addition to cytogenetics, other biomarkers, morphology, and other clinical information, Abbott said.

Several large clinical studies as well as guidelines from the National Comprehensive Cancer Network suggest that chromosomal abnormalities associated with AML are "valuable prognostic indicators," the company said, adding that deletion of chromosome 5q is associated with an unfavorable prognosis in AML patients.

In one study, conducted as part of an Eastern Cooperative Oncology Group clinical trial, FISH technology was able to separate AML patients into risk categories based on chromosomal status or changes, allowing physicians to create better disease management plans for patients, said Abbott, which last week announced it was splitting its medical products division — which includes its diagnostics business — and its research pharmaceuticals division into two separate, publicly traded companies.

Abbott's assay "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," Stafford O'Kelly, head of Abbott's molecular diagnostics business, said in a statement.

The assay is the third from Abbott to receive FDA clearance in recent months for oncology applications. In late August, FDA cleared Abbott's Vysis ALK Break Apart FISH Probe Kit for use as a companion diagnostic with Pfizer's Xalkori (crizotinib) ALK-inhibitor. The same month the agency cleared the Vysis CLL FISH Probe Kit for determining the prognosis of patients with chronic lymphocytic leukemia.

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