Ireland's Trinity Biotech gained a CE mark for its new heart failure point-of-care diagnostic and is now turning its sights toward the U.S. regulatory process within the next few months.
Trinity said European regulators signed off on its Meritas BNP test, which tests for brain or B-type natriuretic peptide (BNP) levels in the blood. It is a good diagnostic marker for heart failure, because BNP levels jump as heart disease advances, the company noted. The test is designed not only to help diagnose heart failure but also to determine how severe it has become.
With a CE mark in place, Trinity executives are immediately turning to the U.S. for their next regulatory approval. The company said it will submit for FDA approval by the end of the 2015 first quarter, with a hope of obtaining approval by the 2015 third quarter. That's right around when Trinity hopes to gain U.S. approval for its troponin test for heart attack detection, which will run on the same platform as the BNP test.
Going for approval in Europe first makes sense, considering that the European life sciences regulatory process is quicker than its U.S. counterpart, though a laborious effort focused on toughening EU regulations continues. Trinity will be extremely efficient with its FDA submission. Most of its CE mark data was generated in the United States, and it will now be beefed up with added U.S. trial data for the expected FDA submission, the company said.
Trinity is pitching lucrative growth possibilities for its Meritas BNP test and troponin product. The company points out in its CE mark announcement that the global point-of-care BNP market alone is worth about $300 million, with a 12% annual growth rate.
"Our outstanding new Meritas BNP test is our second step into the point-of-care cardiac testing market following on from the launch of our troponin test for detecting heart attacks," Trinity Biotech CEO Ronan O'Caoimh said in a statement included with the company's regulatory announcement. "Collectively our troponin and BNP tests will target point-of-care markets which are estimated to be $650 million annually."
Plenty of hype always comes along with a product approval, and Trinity is no different. But giant market expansion isn't guaranteed. Trinity faces plenty of competition from companies including BG Medicine ($MGMD), Critical Diagnostics and others, plus global researchers looking for better and quicker ways to diagnose and treat heart failure before it becomes too advanced.
Trinity acknowledges as much with a commitment to diversify its Meritas diagnostic point-of-care testing menu further. Next on tap: a D-dimer test for deep vein thrombosis, and development is in progress, Trinity said.
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