Trinity diagnostic news
Trinity withdrew its 510(k) submission and will begin a strategic review to determine the best use of its Meritas Troponin-I test technology. The company withdrew the application after FDA raised concerns over the device’s operating temperature range and clinical performance. The company closed its Uppsala facility and terminated 40 employees. The company had 568 employees at Dec. 31, 2015. The point-of-care test detects troponin I from whole blood. Trinity gained the assay through its 2012 acquisition of Fiomi Diagnostics AB. Fiomi has rights to point-of-care diagnostic technology used in the assay from Amic AB, which Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) acquired in 2008 (see BioCentury, June 23, 2008 & March 12, 2012). ...