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KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM)

CPT Code(s): 81402
Specimen Required: Patient Preparation:The KIT D816V for Gleevec Eligibility in ASM is approved by the FDA as a Humanitarian Use Device for qualitative polymerase chain reaction (PCR) detection of KIT D816V mutational status in patients with aggressive systemic mastocytosis (ASM). Testing must be ordered using the following instructions: 1. The ordering physician must register with the Internal Review Board (IRB) for KIT D816V for Gleevec Eligibility in ASM testing. Go to to obtain IRB registration online. 2. The test should be ordered using the RDL test requisition form or via RDL's web-based ordering interface (available only to existing RDL clients). The full name of the ordering physician must be included on the RDL form to ensure timely testing of the specimen. Specimens submitted with incomplete information may delay specimen testing. 3. To send a specimen to RDL, contact your local hospital/reference lab to determine if they are an RDL client and can send the specimen. If they cannot send the specimens to RDL, contact RDL Client Services at (888) 431-7474 to be directed to an alternative ordering mechanism. 4. Information about the KIT D816V for Gleevec Eligibility in ASM test and IRB registration may be accessed at 5. RDL 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 (handled by the Exception Handling services group) after evaluation 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 Molecular Oncology clinical laboratory, and testing will proceed.
Collect:Fresh bone marrow.
Specimen Preparation:Transfer 3 mL bone marrow to an EDTA tube. (Min: 1 mL)
Storage/Transport Temperature:Refrigerated.
Stability:Specimen must be received and testing initiated within: Ambient: Unacceptable; Refrigerated: 3 days; Frozen: Unacceptable
New York DOH Approval Status: This test is New York DOH approved.
  • Asp816ValC-KITCKITD816VGleevacKIT exon 17