Ischemia Technologies Inc has received US Food and Drug Administration (FDA) clearance to market the Albumin Cobalt Binding (ACB) test for detection of Ischemia Modified Albumin (IMA). IMA is a serum biomarker that can be used as an aid to the early evaluation of acute coronary syndromes (ACS) prior to heart attack in patients presenting with chest pain suggestive of cardiac origin. The ACB test uses a small amount of blood drawn from a patient, which is then run on a chemistry instrument commonly available in hospital laboratories.
Chest pain is the second most common reason for visiting an emergency department (ED) in the United States, prompting 6 million patient visits each year. Only about one in five patients with chest pain will ultimately be diagnosed with ACS. The challenge for emergency physicians is to determine which patients have ACS, and which can be safely discharged home. Currently available tests such as electrocardiography (ECG) and other biomarkers such as troponin are limited in their impact on making "rule-out" decisions in the ED. This decision process often takes from 8 to 24 hours, and costs Medicare and private insurance companies thousands of dollars per visit.
"The availability of a new, highly sensitive, serum marker for myocardial ischemia will have significant impact on clinical practice in the emergency department," stated Charles Pollack, chairman of the emergency department at Pennsylvania Hospital and associate professor at the University of Pennsylvania, and a clinical investigator of IMA. "For the majority of chest pain patients we see in the ED, the ECG and other tests like troponin do not help. IMA results will help direct the use of both diagnostic and therapeutic resources in a more cost-effective and risk-appropriate fashion. When used properly, IMA could significantly shorten ED lengths of stay and reduce expense for low-risk patients."
"For several years, the clinical community has been looking for a reliable, inexpensive test to determine which chest pain patients can be sent home safely," explained Robert Jesse, associate professor of cardiology at the Medical College of Virginia, which was one of twenty research sites involved in clinical studies of IMA. "Studies showed that IMA, when used in conjunction with ECG and troponin, correctly identified low-risk patients who could be discharged safely using test results from patient presentation, without the need for more extensive testing in the ED."
"FDA clearance is a great achievement for our company, and is the culmination of over a decade of scientific research and development on IMA," noted Peter Crosby, president and CEO of Ischemia Technologies. "In developing this test, we have been fortunate to have advising us many of the leading chest pain researchers and physicians worldwide. These experts have suggested guidelines for how best to use IMA to assist clinical decision-making by emergency physicians. We are also grateful for the tremendous involvement of the FDA."
The emergency physician currently has three diagnostic tools available at the time a patient presents to help assess the likelihood of ACS: 1) ECG, which measures electrical activity of the heart; 2) biomarkers of cardiac necrosis (troponin, CKMB, myoglobin), and 3) history and physical exam, to observe physical condition and identify cardiac risk factors such as obesity, smoking, family history, and diabetes.
Using these tools at patient presentation, the emergency physician can typically diagnose 12 per cent of patients based on diagnostic ECG or elevated markers of necrosis. Another 13 per cent can be considered for discharge based on history and physical findings. This leaves about 75 per cent of patients in a "grey zone", in which the emergency physician must weigh the trade-offs of accelerating treatment versus "watchful waiting" and additional diagnostic testing. IMA adds a fourth diagnostic tool, which may assist emergency physicians to "rule out" ACS in low risk patients. With IMA, up to 40 per cent of chest pain patients could be safely discharged within a few hours.