Lupus diagnostics gets USFDA approvalJuly 17, 2018
The USFDA has granted approval for PerkinElmer’s lupus diagnostics for sale in the US.
Current tests available to diagnose lupus lack in sensitivity and specificity. PekinElmer developed its C. luciliae immunofluorescence test (CLIFT) and CLIFT-sensitive assays to help labs diagnose Lupus by measuring antibodies.
The approval was based on the data presented from a three-site clinical study of 364 samples. The specificity of the test in the study ranged from 91.6% to 97%, depending on the mode used. Sensitivity came in between 33% and 38.8%.
FDA’s clearance of the EUROIMMUN CLIFT assays help clinicians detect autoimmune disorders more quickly and accurately and provide personalized care for those with lupus.