Soluble Mesothelin Related Peptides (MESOMARK®)
0081284
Ordering Recommendation
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.
Mnemonic
MESO
Methodology
Quantitative Enzyme-Linked Immunosorbent Assay
Performed
Thu
Reported
1-8 days  
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
Patient Preparation
  
Collect
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 Internal 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
Frozen.  
Unacceptable Conditions
  
Remarks
  
Stability
After separation from cells: Ambient: Unacceptable; Refrigerated: 24 hours; Frozen: 3 months  
Reference Interval
0.0-1.5 nmol/L  
Interpretive Data
The Fujirebio Diagnostics, Inc. MESOMARK® is an enzyme-linked immunosorbent assay for the quantitative measurement of soluble mesothelin related peptides (SMRP) in serum. Measurement of SMRP may aid in the management of patients diagnosed with epithelioid or biphasic mesothelioma. Epidemiologic studies have established exposure to asbestos fibers as the primary cause of malignant mesothelioma. Results obtained with different assay methods or kits cannot be used interchangeably.

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.  
Note
The ordering physician must register with the Institutional Review Board (IRB) for MESOMARK® testing. Go to www.fdi.com/mesomark to obtain IRB certification.
CPT Code(s)
86316
Components
Component Test Code*Component Chart Name
0081285Soluble Mesothelin Related Peptides
0081289Mesothelin Ordering MD:
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • MESOMARK (Soluble Mesothelin Related Peptides (MESOMARK(R)))
  • Mesothelin
  • SMRP