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PerkinElmer Receives FDA Clearance for Lupus Dx Tests

NEW YORK (360Dx) – PerkinElmer announced today that its Euroimunn Crithidia luciliae test (CLIFT) and CLIFT sensitive immunofluorescence assays have received 510(k) clearance from the US Food and Drug Administration.

CLIFT testing supports the detection of anti-double-stranded DNA, one of the markers for the rheumatic autoimmune disease systemic lupus erythematosus (SLE), PerkinElmer said. The company also noted that the prevalence of anti-dsDNA ranges from 40 percent to 90 percent in lupus patients.

Immunological tests such as ELISA and RIA detect anti-dsDNA antibodies but only at sensitivities around 20 percent, according to PerkinElmer. The Euroimmun CLIFT sensitive assay, when performed on the fully automated EuroPattern microscope and software system, improves sensitivity by 30 percent versus other serological tests, helping minimize false negative results. Specificity is maintained simultaneously, helping clinical labs to avoid false positive results, the firm added.

"Correct diagnosis is a prerequisite to determining effective treatment," Prahlad Singh, executive vice president and president for PerkinElmer's diagnostics business, 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 acquired Euroimmun a year ago for $1.3 billion.