By Chris Wack
Thermo Fisher Scientific Inc. said the Food and Drug Administration has cleared its Thermo Scientific EliA RNA Pol III and EliA Rib-P tests for aiding in the diagnosis of Systemic Sclerosis and Systemic Lupus Erythematosus.
With these new tests, the company said, the EliA portfolio provides a more robust clinical offering through a comprehensive menu of automated connective tissue disease tests.
RNA Polymerase III is a criteria marker for SSc with both diagnostic and prognostic value. Also, in patients who are positive for RNA Polymerase III, up to 70% may have no other SSc associated antibodies present. The EliA RNA Pol III test completes a criteria based EliA SSc panel and is the first fully automated RNA Polymerase test available in the U.S.
The EliA Rib-P test is designed with optimal sensitivity and specificity and can be used to support the diagnosis of SLE, particularly in ANA negative patients.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
06-09-22 0849ET