Thermo Fisher tests cleared by FDA

 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.

https://www.marketscreener.com/quote/stock/THERMO-FISHER-SCIENTIFIC-14623/news/Thermo-Fisher-Scientific-Tests-Get-FDA-Clearance-40681947/