FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: MESOMARK™
Manufacturer: Fujirebio Diagnostics Inc.
Address: 201 Great Valley Parkway, Malvern, PA 19355-1307
Approval Date: January 24, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/h060004a.pdf
What is it? MESOMARK™ is a laboratory test that is used as an adjunctive test to measure the amount of unique protein fragments (called soluble mesothelin related peptides) in a patient’s blood sample to determine whether a rare cancer of the internal body lining called mesothelioma has gotten worse.
How does it work?
- Cells of malignant mesothelioma (a cancer of the cells lining the chest and abdominal cavities) may release protein fragments into a patient’s blood.
- A sample of blood is drawn from the patient and added to specific chemicals in the MESOMARK™ test.
- The protein fragments in the patient’s blood react with the chemicals in the test.
- A color reaction is produced and is measured inside an instrument.
- The amount of color produced shows the level of fragments in the blood.
When is it used? The MESOMARK™ test is used for patients who are already known to have malignant mesothelioma with epithelioid features. and who are under treatment after surgery for the tumor. To date, the test has been examined for a small number of patients undergoing chemotherapy after surgery for mesothelioma arising in the chest cavity.
What will it accomplish? The MESOMARK™ test when used with other clinical and laboratory tests may help a doctor to monitor the disease course of this type of mesothelioma. Changes in the amount of protein fragment may reflect changes in the amount of tumor in the patient; however, effective performance in this regard has not been established.
When should it not be used? MESOMARK™ test should not be used in patients who:
- have not been diagnosed with mesothelioma with epithelioid features..
SSPB and Labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=h060004