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FDA-approved companion diagnostic

PDGFRB FISH Assay

Direct FISH assay that detects PDGFRB gene rearrangements in blood or bone marrow cells from patients with suspected myeloid neoplasms to support diagnosis and therapy planning.

Lab-developed CDxMethod: FISHSpecimen: Bone marrowBiomarker: PDGFRB gene rearrangement
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Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
H140005
Supplements
Manufacturer
ARUP Laboratories, Inc.
Approval date
December 18, 2015
Test specifications
Methodology
FISH
Specimen
Bone marrow
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
PDGFRB gene rearrangement
What this test is

PDGFRB FISH Assay is a qualitative fluorescence in situ hybridization test that uses labeled DNA probes to detect rearrangements involving the PDGFRB gene in interphase nuclei from peripheral blood or bone marrow. By identifying PDGFRB gene fusions in myeloid or lymphoid neoplasms with eosinophilia, it helps confirm diagnosis and supports selection of appropriate tyrosine kinase inhibitor–based treatment strategies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Myelodysplastic Syndromes (MDS)PDGFRBPDGFRB gene rearrangement at 5q31~33GLEEVEC

Performing lab

ARUP Laboratories, Inc.

ARUP Central Facility (46D0523979)

Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the University of Utah Spencer Fox Eccles School of Medicine and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine™. ARUP is ISO 15189 and CAP accredited. For more information, visit www.aruplab.com.

Order this test

If your organization is connected to Casandra, you can place an electronic order forPDGFRB FISH Assay directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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