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TEST:
PDGFRB FISH Assay

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Company:

Type:

FDA Approved

PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome/Myeloproliferative Disease (MDS/MPD) is an in vitro diagnostic test intended for the qualitative detection of PDGFRB gene rearrangement from fresh bone marrow samples of patients with MDS/MPD with a high index of suspicion based on karyotyping showing a 5q31~33 anomaly. The PDGFRB FISH assay is indicated as an aid in the selection of MDS/MPD patients for whom Gleevec® (imatinib mesylate) treatment is being considered. This assay is for professional use only and is to be performed at a single laboratory site.

Cancer:

Myelodysplastic Syndrome, Myeloproliferative Neoplasm

Gene:

PDGFRB (Platelet Derived Growth Factor Receptor Beta)

Drug:

imatinib

Method:

Fluorescence in situ hybridization (FISH)

Approvals

Date

Cancer

Gene