PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome/Myeloproliferative Disease (MDS/MPD)
Companion Diagnostic
PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome/Myeloproliferative Disease (MDS/MPD) is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
This assay is intended for qualitative detection of PDGFRB gene rearrangement in patients with MDS/MPD who have a high index of suspicion based on karyotyping showing a 5q31–33 anomaly. It serves as an aid in selecting patients for whom imatinib (Gleevec®) treatment is being considered.
Special Instructions
Device is a Humanitarian Device authorized under HDE. Ordering physician must be registered via IRB as directed on ARUP website. The test must be ordered using ARUP test request form or web interface, including full name of ordering physician to avoid delays. For specimen submission, contact local ARUP client site or Client Services for alternative ordering.
Limitations
Effectiveness has not been demonstrated. Requires fresh bone marrow; not validated for other specimen types. Restricted to professionals. Performed at single laboratory site.
FDA ApprovedCompanion Diagnostic
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Specimen
Tumor Tissue
Volume
Not provided
Minimum Volume
Not provided