FDA clears blood tests for systemic sclerosis, lupus diagnoses
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The FDA has cleared two tests from Thermo Fisher Scientific to help diagnose systemic sclerosis and systemic lupus erythematosus, according to a company press release.
The EliA RNA Pol III and EliA Rib-P tests help diagnose SSc and SLE, respectively. EliA RNA Pol III works by completing a criteria panel for SSc and is the first fully automated RNA polymerase test available for the disease in the United States, the release said. The EliA Rib-P test works to detect monospecific ribosomal P antibodies and will be useful in supporting SLE diagnoses in ANA-negative patients, according to the company.
“Autoimmune diseases can be a challenge to diagnose,” Henry Homburger, MD, professor emeritus of laboratory medicine at the Mayo Clinic College of Medicine, and director of the Thermo Fisher Phadia Immunology Reference Laboratory, said in the release. “Reliable and accurate laboratory tests that provide clinical clarity are essential tools for clinicians managing these patients. The addition of RNA Polymerase III and Ribosomal P to the EliA connective tissue disease test menu will add considerable value to the diagnosis of SSc and SLE.
“The new EliA RNA Pol III and EliA Rib-P tests have been designed to improve the differentiation of SSc and SLE from other connective tissue diseases,” Homberger added. “Targeting existing diagnostic care gaps can potentially lead to earlier and more accurate diagnosis and ultimately improve clinical outcomes for patients.”
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