Thermo Fisher Scientific Launches New AMI Biomarker Test in Europe
October 28, 2009 – Thermo Fisher Scientific Inc. today announced the availability in Europe of its new Copeptin assay, which helps medical personnel quickly and accurately diagnose acute myocardial infarction (AMI).
Copeptin, developed by recently acquired B.R.A.H.M.S. AG, is a patented biomarker for AMI and is detectable using a simple blood test that, in combination with a Troponin biomarker test, permits doctors to rule out or confirm the onset of a heart attack within minutes. Currently, physicians rely on an electrocardiogram in combination with Troponin which, in most patients with chest pain, cannot indicate AMI until at least four hours after the onset of symptoms and requires additional testing after six to nine hours.
“We acquired B.R.A.H.M.S. to strengthen our specialty diagnostics offering, and today’s news demonstrates how quickly that investment is adding value to our technology portfolio,” said Yuh-Geng Tsay, Ph.D., head of Thermo Fisher Scientific’s specialty diagnostics business. “Our company continues to push innovation in biomarker discovery and applications. The Copeptin assay shows that we’re having an impact by helping physicians to be more effective at diagnosing disease, which ultimately improves patient health and also lowers the cost of care.”
AMI is the leading cause of death worldwide. Approximately 15 million patients visit an emergency room each year with symptoms, however, only about 10 percent are eventually diagnosed with AMI. The Copeptin assay allows physicians to provide immediate answers. It accelerates treatment, prevents heart damage caused by prolonged wait time and streamlines the treatment of non-AMI patients. Copeptin can save valuable time, healthcare resources and, most importantly, human lives.
The test is now commercially available throughout Europe. In the U.S., Thermo Fisher is in the process of generating the data to support a 510(k) premarket application for the test, and plans to submit the data to the U.S. Food and Drug Administration at the end of 2010.
Thermo Fisher Scientific completed the acquisition of B.R.A.H.M.S. on Oct. 1, 2009.
For more information: www.thermofisher.com
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