Trinity Biotech Plummets 50%: Here's What You Need To Know

Trinity Biotech plc (ADR) TRIB, an Ireland-based developer and manufacturer of medical diagnostics products for the clinical laboratory and point-of-care segments of the diagnostics market, plunged more than 50 percent Tuesday.

Trinity Biotech said it has withdrawn its 510(k) premarket notification submission for its Meritas Troponin-I Test and Meritas Point-of-Care Analyzer.

Trinity Biotech noted that it held a meeting with the U.S. Food and Drug Administration on September 29 to obtain an update on its Meritas Troponin submission. During the meeting, the FDA asked to consider withdrawing its submission due to what the company described as "some concerns they have about the submission."

Specifically, the FDA's concerns relate to the device's operating temperature range and that the Troponin-I clinical performance is not consistent with clinical performance data which were detailed in the most recently laboratory cleared Troponin device.

Given the FDA's request, the company decided to withdraw its submission, but will engage with the agency to gain a better understanding of their concerns.

Trinity Biotech added that in order to gain regulatory clearance, the FDA will require the company to demonstrate performance equivalent to the most recently cleared laboratory based device.

"Our decision to withdraw is based on the fact that, notwithstanding its excellent performance characteristics, we believe that there is no certainty that this level of performance can be achieved by the Meritas product even with the benefit of further development efforts," Trinity Biotech said in its release.

Moving forward management will now "embark upon an internal process to determine the best future opportunity for this technically excellent platform."

The company said it will also recognize a non-cash write-off in excess of $50 million which represents the costs incurred on the project and will be reflected in its fourth quarter income statement.

The stock traded at $6.51, down 49 percent.