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MESOMARK(®) in vitro diagnostic test for mesothelioma.
Zhong-Qian Li1, Thorsten Verch, W Jeffrey Allard
1Fujirebio Diagnostics, Inc., Department of Research and Development, 201 Great Valley Parkway, Malvern, PA 19355, USA +1 610 240 3938 ; +1 610 240 3803 ; liz@fdi.com.
Expert Opinion on Medical Diagnostics
|March 16, 2013
Summary
The MESOMARK test is the only FDA-approved blood test for managing mesothelioma patients. It measures soluble mesothelin, aiding in monitoring epithelioid and biphasic malignant mesothelioma.
Area of Science:
- Oncology
- Biomarker Research
Background:
- Mesothelioma is an aggressive cancer with limited treatment options.
- Accurate patient management and monitoring are crucial for improving outcomes.
- The need for reliable diagnostic and monitoring tools in mesothelioma is significant.
Purpose of the Study:
- To introduce and evaluate the MESOMARK in vitro test.
- To highlight its role in the management of mesothelioma patients.
- To discuss its regulatory approvals and applications.
Main Methods:
- Evaluation of the MESOMARK in vitro test.
- Review of clinical data and regulatory submissions.
- Analysis of soluble mesothelin measurement.
Main Results:
- MESOMARK is the only US FDA-approved blood test for mesothelioma management.
- The test is approved/licensed in Europe, Australia, New Zealand, and Canada.
- It measures soluble mesothelin (or soluble mesothelin-related peptides).
Conclusions:
- The MESOMARK test is a valuable tool for monitoring patients with epithelioid and biphasic malignant mesothelioma.
- Its international approvals underscore its utility in clinical practice.
- Soluble mesothelin measurement offers a non-invasive approach for patient management.
