Trinity Biotech pulls US heart attack test filing

Trinity Biotech, which makes diagnostic test kits, has pulled a filing with US authorities for approval of a product for diagnosing heart attacks.

As the company reviews how to use the technology behind the product, including which markets to focus on, Trinity plans to close its Swedish facility in Uppsala with a loss of 40 jobs. The technology will be moved to its Bray facility in Wicklow. Trinity will also incur a $50 million non-cash write-off of costs incurred in the project.

Trinity said in a statement that it met with US Food and Drug Administration officials last week to obtain an update on its premarket notification submission for the heart attack diagnosis Meritas Troponin-I test and Meritas Point-of-Care Analyzer.

“At this meeting the FDA asked Trinity to consider withdrawing their submission due to some concerns they have about the submission,” it said.

Temperature range

“Their primary concern relates 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.”

Trinity said it believed that its product “demonstrates excellent performance” and was “superior to all existing point-of-care” Troponin products in the market.

The company decided to withdraw the submission on Monday, and will engage with the FDA over the coming weeks to better understand its concerns.

However, Trinity said it believed it would have to demonstrate performance equivalent to the most recently cleared laboratory device and that there was “no certainty” that this could be achieved by its Meritas product even with the benefit of further developments.