Humanitarian Device. Authorized by Federal law for use in the qualitative detection of PDGFRB gene rearrangement in patients with myelodysplastic syndrome/myeloproliferative disease (MDS/MPD). The effectiveness of this device for this use has not been demonstrated. Caution: Federal law restricts this device to sale by or on the order of a licensed practitioner.
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.
- Patient Preparation
- PDGFRB FISH for Gleevec Eligibility in MDS/MPD is approved by the FDA as a Humanitarian Device for FISH testing of the PDGFRB gene to determine mutational status in patients with MDS/MPD. Testing must be ordered using the following instructions:
1. The ordering physician must register with the Internal Review Board (IRB) for PDGFRB FISH for Gleevec Eligibility in MDS/MPD testing. Go to http://www.aruplab.com/PDGFRB to obtain IRB registration online.
2. The test should be ordered using the ARUP test requisition form or via ARUP's web-based ordering interface (available only to existing ARUP clients). The full name of the ordering physician must be included on the ARUP form to ensure timely testing of the specimen. Specimens submitted with incomplete information may delay specimen testing.
3. To send a specimen to ARUP, contact your local hospital/reference lab to determine if they are an ARUP client and can send the specimen. If they cannot send the specimens to ARUP, contact ARUP Client Services at (800) 522-2787 to be directed to an alternative ordering mechanism.
4. Information about the PDGFRB FISH for Gleevec Eligibility in MDS/MPD test and IRB registration may be accessed at www.aruplab.com/PDGFRB.
5. ARUP will receive specimens via usual shipping routes, from designated clients. When the specimen arrives, with an accompanying requisition, the physician's full name will be logged in, if present. If the ordering physician's full name is not present, the specimen is placed on EXCEPT by the Integrated Oncology and Genetics (IOG) services group. The IOG services group will then attempt to locate the physician for confirmation of IRB registration. Upon confirmation of physician registration, the IOG services group will notify the Cytogenetics clinical laboratory, and testing will proceed.
- Non-diluted bone marrow aspirate collected in a heparinized syringe. Also acceptable: Green (sodium heparin).
- Specimen Preparation
- Transfer 3 mL bone marrow to a green (sodium heparin) tube. (Min: 1 mL)
- Storage/Transport Temperature
- Room temperature.
- Unacceptable Conditions
- Paraffin-embedded specimens. Clotted specimens.
- Specimen must be received and testing initiated within: Ambient: 3 days; Refrigerated: Unacceptable; Frozen: Unacceptable
|Component Test Code*||Component Chart Name||LOINC|
|2013144||PDGFRB FISH for Gleevec in MDS/MPD|
|2013145||EER PDGFRB Gleevec by FISH|
- PDGFR-beta Rearrangement
- PDGFRB Rearrangement
- PDGFRB, 5q33.1