i-STAT Corporation has received U.S. Food and Drug Administration clearance to market its 10-minute i-STAT System Cardiac Troponin I (cTnI) test. The i-STAT System Troponin I test is the first product in the market that offers central laboratory-grade performance at the patient's bedside. Data from the clinical trials showed the i-STAT System Troponin I test to have the sensitivity necessary to pick up even the slightest elevation, as any troponin is indicative of heart damage.

The American College of Cardiology's preferred protocol for assessing patients with chest pain includes a Troponin I measurement within 30 minutes of patient presentation at the Emergency Department. Now, with i-STAT, it is as easy as a single drop of blood and 10 minutes. Prior to the i-STAT Troponin I test, emergency physicians and cardiologists often waited over an hour for these critical test results. The Company will begin to ship the Troponin I test to customers later this month.

Two medical studies underscore the advantages of point of care testing (POCT) and troponin markers. According to an American Heart Association study in 2002, hospitals that did follow the 30-minute treatment guideline improved heart attack patients' survival by one-third, compared with hospitals who did not achieve rapid turnaround time. An April 2003 study in Archives of Pathology and Laboratory Medicine reported that turnaround time for cardiac troponin and other cardiac marker tests improved by 84.5 percent with POCT (17 minutes) compared with a central laboratory (110 minutes). In addition to diagnosing patients faster and more easily, the i-STAT Troponin I test is also expected to save hospitals money by rapidly identifying the 10-15% of patients who are admitted with chest pain but aren't suffering a heart attack, and often undergo unnecessary testing and hospitalization.