The FDA has allowed marketing of the EUROIMMUN Anti- PLA2R IFA blood test, the first non-invasive test to help determine if membranous glomerulonephritis (MGN) is autoimmune or if it is due to another cause (eg, infection). The EUROIMMUN Anti- PLA2R IFA blood test detects if a patient has an antibody that is specific to primary MGN (pMGN).
The FDA reviewed a clinical study of 560 blood samples of which 275 samples were obtained from patients with presumed pMGN. Of these, 285 samples were from patients with other kidney diseases (including secondary MGN) and autoimmune diseases, not including pMGN. Data showed that the test was able to detect pMGN in 77% of the presumed pMGN samples, and gave a false positive result in <1% of the other disease samples. The test was also helpful in distinguishing between pMGN and sMGN.
The EUROIMMUN Anti- PLA2R IFA blood test was reviewed by the FDA through its de novo classification process.
For more information call (800) 913-2022 or visit Euroimmun.US.