Roche has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Elecsys Troponin T Gen 5 STAT (TnT Gen 5 STAT) blood test for patients with a suspected heart attack.
Roche is claimed to be the first IVD company in the US to offer the next generation Troponin testing to diagnose myocardial infarction (AMI) in patients, allowing clinicians to identify patients with heart attack.
Elecsy TnT Gen 5 STAT test will identify cardiac troponin, a preferred biomarker to diagnose heart attack in clinical practice.
The test, along with an electrocardiogram (ECG) and signs of ischemia, will be effective in the diagnosis of heart attack.
According to the company, the new Troponin T test can provide accuracy at lower levels of troponin to correctly detect patients with an AMI.
Baylor Medical Center Houston FACEP – ED physician Dr Frank Peacock said: "As an emergency doctor whose job is to make decisions on patients with chest pain, my ability to do this safely and accurately is driven by the sensitivity of the troponin assay.
“FDA clearance of this new Roche TnT assay is easily the best news in the last decade for emergency medicine patients presenting with chest pain."
Earlier this month, the firm also received FDA approval for its Anti-Müllerian (AMH) assay to assess ovarian reserve.
Via direct de novo decision, the approval was granted for Elecsys AMH test, which will enable doctors to help women looking to become pregnant or struggling with infertility.
Image: Roche Diagnostics North American headquarters in Indianapolis. Photo: courtesy of PRNewsFoto / Roche.