The FDA has cleared PerkinElmer’s lupus diagnostics for sale in the U.S. PerkinElmer designed the tests to run on its automated EUROPattern microscope, thereby cutting turnaround times.
Lupus is diagnosed by measuring antibodies against double stranded DNA using one of several types of test. None of these tests has ideal sensitivity and specificity, leading many labs to run a second, confirmatory assay using one of the other diagnostics. The relatively high specificity of the C. luciliae immunofluorescence test (CLIFT) has secured it a prominent place in this diagnostic sequence.
PerkinElmer developed its CLIFT and CLIFT-sensitive assays to help labs run the test. Labs perform the tests using PerkinElmer’s automated EUROPattern microscope and accompanying software. As the microscope can render digital images within 13 seconds per field, PerkinElmer thinks the approach will cut the time it takes to deliver CLIFT results. The system’s automated classification may also lead to results being interpreted less subjectively.
With the FDA clearing the tests for sale through the 510(k) pathway, PerkinElmer is now set to start making this pitch to potential buyers in the U.S.
“Correct diagnosis is a prerequisite to determining effective treatment,” PerkinElmer EVP Prahlad Singh said in a statement. “The FDA’s clearance of the EUROIMMUN CLIFT assays represents a significant milestone in helping clinicians more quickly and accurately detect autoimmune disorders and provide personalized care for those with lupus.”
PerkinElmer secured the clearances on the strength of filings that presented data 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%.