Trinity Biotech Withdraws Troponin FDA 510(k) Submission

(RTTNews) - Trinity Biotech plc (TRIB) said that it is withdrawing its 510(k) premarket notification submission for the Meritas Troponin-I Test and Meritas Point-of-Care Analyzer.

The company held a meeting with the FDA on Thursday 29 September, in order to obtain an update on the company's Meritas Troponin submission. At this meeting the FDA asked Trinity to consider withdrawing their submission, due to some concerns they have about the submission. Their primary concerns relate to the device's operating temperature range and that the Troponin-I clinical performance is not consistent with the clinical performance data presented by the most recently cleared laboratory Troponin device.

The company noted that it will now embark upon an internal process to determine the best future opportunity for this technically excellent platform, concentrating on which products and markets it should focus on, including establishing the optimal strategic outcome for Troponin. This process is expected to take between 9 and 12 months.

In the meantime the company has decided to move the technology from Swedish facility in Uppsala to facility in Bray, Ireland where it will be incorporated into existing R&D and manufacturing infrastructure. This will result in the closure of the Uppsala facility, which will result in approximately 40 redundancies.

Consequently expenditure levels, which are currently running at an annualised rate of over $9 million, will be reduced to approximately $1.5 million per annum. There will however, be Swedish redundancy and closure costs which are currently in the process of being determined. The company will also recognise a non-cash write-off in excess of $50 million, representing the costs incurred on the project, which will be recognised in fourth-quarter income statement.