Trinity Biotech yanks FDA submission for point-of-care heart failure test

(Trinity Biotech)

Trinity Biotech has traveled a rough road with its point-of-care test for heart failure, and now, it’s reached the bitter end. The company is pulling back its FDA submission for the device after regulators voiced some concerns about the diagnostic.

Trinity’s decision comes after meeting with the FDA last month. On September 29, regulators told the Dublin-based company that they had some issues with its Meritas Troponin-I Test and Meritas Point-of-Care Analyzer. The product look for a protein, troponin, which appears in the blood when the heart is damaged.

The FDA pointed to problems with the device’s temperature range and clinical performance, Trinity said in a statement. Results yielded from Troponin-I did not match those from the company’s most recently cleared lab device for heart failure testing, regulators said.

But Trinity is standing by its test. The device "demonstrates excellent performance for a point-of-care product and is superior to all existing point-of-care Troponin products on the market," the company said. But it’s still withdrawing its submission for the test, it added.

“Over the coming weeks, we will engage with the FDA to gain a better understanding of the nature of their concerns,” Trinity said in a statement. “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 is also rejiggering operations as a result of the failed submission. Over the next nine to 12 months, the company will “embark upon an internal process” to figure out the best course of action for the device.

Meanwhile, Trinity is shuttering its Swedish R&D facility that worked on Meritas. The company will move the technology to its Irish R&D and manufacturing hub, a decision that is expected to cause 40 job cuts.

The company is also reducing spending by almost 85% to $1.5 million from $9 million a year as a result of the withdrawn submission.

The regulatory failure marks a low point for Trinity, which has struggled with its heart failure test. The company got a CE mark for Meritas in 2014 but delayed submitting the product for U.S. approval multiple times.

Still, around this time last year Trinity management sounded upbeat that the device would gain stateside approval. “All indications for our clinical data are excellent,” CSO Jim Walsh said on an October 2015 earnings call.

- here’s the statement