“Time is muscle” is a common phrase among cardiac surgeons treating heart attacks, says Roche Diagnostics Chief Medical Officer Dr. Alan Wright. A heart attack occurs when blood flow that brings the heart oxygen is severely reduced or cut off, causing heart muscle to die; as more time passes, more heart muscle dies. Emergency room (ER) physicians are just days away from having a new Roche-developed tool in their hands that speeds the detection of a heart attack, preserving precious muscle.
“Any time you can speed up the diagnosis by detecting a heart attack earlier, it saves more lives and decreases the disability of patients,” says Wright. “Roche is honored to make this contribution to medicine; it’s a significant step forward.”
The U.S. Food and Drug Administration approved Indianapolis-based Roche Diagnostics’ TnT Gen 5 STAT blood test in January. The Indianapolis-based company is the first in the U.S. to provide the new tool; it’s been available in Europe for seven years due to a less lengthy regulatory process. The test involves taking a blood sample from the patient to detect troponin, an enzyme in the heart that leaks into the bloodstream when heart muscle dies.
“Our test detects troponin as it’s floating around in the blood. It leaks in small amounts at first, but as more and more muscle dies, the more the cells leak, and the level of troponin in the blood rises,” says Wright, who began his medical career as an ER physician. “Catching it and measuring it earlier with this more sensitive [test] enables earlier intervention, and potentially, saving more heart muscle during that heart attack.”
While ERs have used tests that detect troponin for years, Wright says TnT Gen 5 STAT is more accurate and sensitive, detecting a lower level of troponin than its predecessors. It’s the fifth generation TnT test for Roche, but the most precise and fastest, providing a result in just nine minutes.
In addition to identifying patients who are having a heart attack, Wright says using the test to rule out a heart attack is equally important, so physicians can find the true cause of the symptoms. Roche says some 8 million Americans go to the ER each year with chest pain and other symptoms indicative of a heart attack, but only five-to-20 percent are actually having one.
Wright says the first diagnostic used in the ER is typically an electrocardiogram, but it doesn’t always produce definitive results, which leads doctors to perform the blood test.
“[TnT Gen 5 STAT] runs on our analyzers that are already used by many hospitals, so new equipment doesn’t have to be installed,” says Wright. “A lab that has Roche analytic instruments installed has ready access to our fifth generation troponin test.”
The actual test is comprised of antibodies that attach to troponin circulating in the blood. Roche manufactures the antibodies in Europe and ships them to the U.S.; the company says production has already been scaled up for earlier clinical trials, so the test is distribution-ready.
“It’s been long anticipated. There are many scholarly papers being published in Europe discussing the benefits of the use of this [test], so it’s been eagerly anticipated to finally get it introduced to the U.S.,” says Wright. “There’s been a lot of excitement; many of my colleagues are really eager to get the test—calling me up asking when it was going to be approved.”
Roche says it’s now poised to deliver the TnT Gen 5 STAT test to ERs throughout the country, giving doctors the industry’s most sensitive test during the critical moments when “time is muscle.”
Wright explains the science behind the antibody-based test.
Wright says the FDA’s regulatory process is the main reason the test was available in Europe seven years earlier than in the U.S.