Nanomix will test its new heart attack blood diagnostic test on 170 people in an upcoming U.S. clinical trial, the California company disclosed.
In advancing the Omega-3 Cardiac Panel point of care diagnostic to human testing, Nanomix is poised to join the ranks of rivals including Abbott Laboratories, Roche and BG Medicine that have developed diagnostic tests meant to screen for, or identify heart attacks in various ways and at different stages.
Nanomix envisions a two-month trial involving healthy subjects, with the idea of developing baseline data in advance of broader clinical trials in the future. The test looks at whole blood specimens for levels of troponin, myoglobin and H-FABP – biomarkers that can help diagnose a myocardial infarction, or heart attack. And the Omega-3, a hand-held diagnostic device, is designed to produce results in about 10 minutes. A Nanomix spokesman explained to FierceMedicalDevices via email that the test is drastically quicker than the several hours required by current lab testing. That's crucial because heart attacks cause damage rapidly, so early intervention makes all the difference.
If Nanomix can successfully obtain a CLIA waiver, plans call for marketing the Omega-3 hand-held diagnostic to hospital emergency rooms, ambulance companies "and other nontraditional settings," according to the spokesman.
Rival Abbott ($ABT) recently gained a CE marking for its Architect STAT test, a diagnostic designed to detect majorly low levels of troponin to determine if a heart attack is happening or will likely happen. But it designed to work within two to four hours. BG Medicine ($BGMD) won a CE mark in December for its CardioScore blood test, which marks patients who have an elevated risk for heart attack or stroke rather than diagnosing the conditions as they are happening. Roche ($RHHBY), meanwhile, generated positive clinical data summer with its own troponin heart attack test that appeared to drastically reduce emergency room diagnostic time.
Nanomix, which is based in Emeryville, CA, launched about 10 years ago with an initial focus on developing extremely sensitive, low-cost biosensors using its own carbon nanotube tech. Executives expanded their focus in 2009 to point-of-care in vitro diagnostics using that technology. Nanomix employs 25 people, has raised $60 million in venture capital to date and plans to raise more money down the line via investors or strategic partners.
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