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FDA-cleared next-gen troponin T test, 6/17

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June 2017—Roche received 510(k) clearance for its Elecsys Troponin T Gen 5 STAT blood test for patients with a suspected heart attack. With this clearance, according to a company statement, Roche is the first IVD company in the U.S. to provide next-generation troponin testing for patients as an aid in the diagnosis of myocardial infarction, enabling clinicians to more accurately identify patients experiencing a heart attack.

Roche, 317-521-2000

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