MESOMARK is FDA approved for use as a Humanitarian Use Device. IRB registration and certification is required prior to ordering. Follow procedures listed below in specimen requirements.
- Patient Preparation
- Serum separator tube or plain red.
Because MESOMARK® is a test approved by the FDA as a Humanitarian Use Device, testing should be ordered using the following procedure(s):
1. The ordering physician must register with the Institutional Review Board (IRB) for MESOMARK® testing. Go to www.fdi.com/mesomark to obtain IRB certification online.
2. The test should be ordered using the ARUP requisition form. 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. Physicians are instructed as follows: ARUP does not accept specimens directly from physician offices. ARUP only accepts specimens from established clients. 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 find an ARUP client in your area.
4. Forms and information about MESOMARK® testing, and IRB registration, may be accessed at www.fdi.com/mesomark.
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 after evaluation by the Special Chemistry department. The Special Chemistry lab will then contact Fujirebio Diagnostics, Inc. (FDI), who will then contact the physician for certification. FDI will then notify ARUP in Special Chemistry of completed certification. Special Chemistry will proceed with testing after certification is completed by the physician.
Collect: Serum separator tube or plain red.
- Specimen Preparation
- Allow specimen to clot completely at room temperature. Transport 0.2 mL serum. (Min: 0.1 mL)
- Storage/Transport Temperature
- Unacceptable Conditions
- After separation from cells: Ambient: Unacceptable; Refrigerated: 24 hours; Frozen: 3 months
Humanitarian Device. Authorized by Federal Law for use as an aid in the management of patients diagnosed with biphasic or epithelioid mesothelioma. The effectiveness of this device for this use has not been demonstrated.
|Component Test Code*||Component Chart Name||LOINC|
|0081285||Soluble Mesothelin Related Peptides||41292-4|
|0081289||Mesothelin Ordering MD:|
- MESOMARK (Soluble Mesothelin Related Peptides (MESOMARK(R)))