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Trinity Biotech withdraws FDA 510(k) filing for point-of-care system and troponin test; shares down 50%

Oct. 04, 2016 9:46 AM ETTrinity Biotech plc (TRIB) StockBy: Douglas W. House, SA News Editor1 Comment
  • Thinly traded micro cap Trinity Biotech (NASDAQ:TRIB) plummets 50% in early trading in response to its announcement that it has withdrawn its 510(k) marketing application from the FDA for its Meritas Point-of-Care Analyzer and the Meritas Troponin-I Test. The company took action following a meeting with the agency during which the reviewers expressed concerns about the filing and suggested the application be withdrawn.
  • The problems relate to the device's operating temperature range and the disparity between the clinical performance data of the Troponin-I test and the most recently cleared laboratory Troponin device. In order to be granted marketing clearance under the 510(k) pathway, Trinity must demonstrate that its Troponin-I test is equivalent to the most recently cleared product.
  • The company stands behind the performance of Troponin-I but admits that there is no certainty that equivalent performance can be achieved. It says that it will initiate an internal review to clarify the best path forward with the platform, a process that may take as long as 12 months to complete.
  • In meantime, Trinity will transfer the technology from its Sweden-based facility to Ireland which will result in the elimination of 40 jobs. It will also record a non-cash charge of over $50M this quarter to account for the costs of the move.
  • Management will host a conference call this morning at 11:00 am ET to discuss the situation.

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