Three biomarkers--troponin, myoglobin and H-FABP--are key elements of a new blood diagnostic that Nanomix plans to test on 170 people in a U.S. clinical trial.
The presence of each biomarker can indicate a myocardial infarction, or heart attack. And the California company's Omega-3 hand-held diagnostic device is designed to measure whole blood specimens in order to measure for each one, generating results in about 10 minutes. That's significantly quicker than the several hours current diagnostic tests take.
Once approved, if Nanomix can win a CLIA waiver, the company will market its device to hospital emergency rooms and ambulance companies, among other clients, a spokesman told FierceBiomarkers. But the initial clinical trial comes first. Nanomix says it will be testing healthy subject for now in a two-month trial in order to collect baseline data, aiming to conduct large-scale clinical trials down the line.
If Nanomix is successful, the company will enter a market with significant rivals, including Abbott Laboratories ($ABT), Roche ($RHHBY). Each has developed diagnostic tests focused on screening for looming or ongoing heart attacks in various ways. But none of them screen for as many biomarkers as the Nanomix test does in as short a time. Abbott, for example, recently gained a CE marking for Architect STAT, a test that can spot very low levels of troponin to determine if a heart attack is likely, or actually happening. Roche is developing its own heart attack test focused on the troponin biomarker, though it is designed to also reduce emergency room diagnostic time.
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