FDA approves and designates Roche Tina-qant Lp Assay as a Breakthrough Device

According to the reports, Roche revealed that the U.S. FDA approved its Tina-quant ® lipoprotein Lp(a) RxDx as a Breakthrough Device. The device will help to identify patients who can benefit from the innovative Lp(a) lowering therapy, which is currently being developed. 

Lp (a) proves to be a critical marker for people at risk of cardiovascular disease. However, the healthcare sector needs more solutions to address this problem effectively. By collaborating with Amgen, Roche has paved a new path to make the elevated Lp(a) an actionable marker, said Matt Sause, the CEO of Roche Diagnostics. 

 Tina-quant ® lipoprotein Lp(a) RxDx is the result of combining Amgen's year-long legacy and expertise in cardiovascular disease with Roche’s diagnostic expertise. 

After its approval, the new Tina-quant® test shall be available to identify the patients who benefit from the Lp(a)- lowering therapy.