Abbott announces FDA clearance for new acute myeloid leukaemia prognosis kit.
M2 EQUITYBITES-October 25, 2011-Abbott announces FDA clearance for new acute myeloid leukaemia prognosis kit(C)2011 M2 COMMUNICATIONS http://www.m2.com
Broadbased healthcare company Abbott (NYSE:ABT) announced on Monday that it has received 510(k) clearance from the US Food and Drug Administration for a new in vitro diagnostic test to aid in determining the prognosis of patients with acute myeloid leukaemia (AML), a common types of leukaemia in older adults.
Abbott's Vysis EGR1 FISH Probe Kit, reportedly 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 unfavourable prognosis for AML patients.
Abbott said that its 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.
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 leukaemia (AML) diagnosis as an aid in determining prognosis. Deletion of chromosome 5q has been associated with an unfavourable prognosis in AML patients.
The company said that its 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 US. In August 2011, the FDA 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.
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