SPECTRAL'S CARDIAC STATUS(TM) TROPONIN I IS CHOSEN TO PARTICIPATE --------------------------------------------------------------------------------
in Centocor's GUSTO IV Acute Coronary Syndromes Clinical Trial
Spectral's Point-of-Care Cardiac STATus Troponin I Panel Test Will be Used in Over 400 Leading Hospital Sites in The United States, Canada, Europe
And Australia/New Zealand
TORONTO, May 12 /PRNewswire/ -- Spectral Diagnostics Inc. (Nasdaq: DIAGF) (Toronto Stock Exchange: SDI), developers of the Cardiac STATus(TM) line of rapid format cardiac diagnostic panel tests with its joint-venture partner, Princeton BioMeditech, reported that Centocor Inc. has chosen to use Spectral's Cardiac STATus Troponin I panel test in its GUSTO IV Acute Coronary Syndromes ("GUSTO IV ACS") clinical trial. The GUSTO IV ACS clinical trial is a multinational, multicentre trial investigating the efficacy and safety of Centocor's anti-platelet therapeutic agent, ReoPro(R) (Abciximab), for the treatment of patients suffering from Acute Coronary Syndromes ("ACS") including heart attack or unstable angina. Using Spectral's Cardiac STATus Troponin I panel test and other inclusion criteria, approximately 7,800 chest pain patients that may benefit from a potent anti-platelet therapeutic agent will be selected from chest pain patients presenting to emergency departments and other acute care settings. More than 400 leading hospital sites in the United States, Canada and Europe are participating in the trial.
In a recent report in the New England Journal of Medicine, the performance of Spectral's Cardiac STATus Troponin I panel test was shown to be superior to other troponin tests in the early identification of patients suffering from Acute Coronary Syndromes.
In making the announcement, Spectral's Chairman and CEO, Mr. Douglas C. Ball said, "We are delighted that Spectral's Cardiac STATus Troponin I panel test has been chosen by Centocor and its key investigators for use in the GUSTO IV ACS clinical trial. In providing an early and accurate identification of patients suffering Acute Coronary Syndromes, our Cardiac STATus Troponin I panel test is shown to be an integral ingredient in specifying patients eligible for leading-edge therapies such as Centocor's ReoPro or alternative courses of intervention or treatment."
Mr. Ball added, "While many of the participating hospitals are already customers of Spectral, the commercial prospects arising from the use of Spectral's Cardiac STATus Troponin I panel tests in the GUSTO IV ACS clinical trial are substantial. By aligning our approach to cardiac diagnostics as an aid leading to better therapeutic and other interventional therapies in the treatment of patients undergoing a cardiac episode, Spectral has the opportunity to enhance usage of our products and obtain a further expansion of our customer base in the United States, Canada and Europe."
Mr. Glenn Mattes, Vice President, General Manger, Cardiovascular Division Unit for Centocor said, "Under acute conditions and emergency settings, Spectral Cardiac STATus Troponin I test is a proven method for the early identification of cardiac risk patients. The test platform provides accurate results in a wide variety of clinical settings which maximizes the opportunity for therapy decisions." Mr. Mattes added, "We believe that Spectral's test is a critical ingredient in the rapid selection of chest pain patients who may benefit from aggressive treatment options. We welcome the opportunity to partner in the clinical trial."
Located in Canada, the United States and Europe, Spectral's scientists, sales and marketing organizations and other professionals are focused on the development and commercialization of its Cardiac STATus line of Controls and diagnostic panel tests including the CK-MB/Myoglobin Panel Test, the Troponin I Panel Test and the patented Cardiac Panel(TM). Spectral's common shares are listed on The Toronto Stock Exchange (symbol SDI) and the Nasdaq - NMS - Exchange (symbol DIAGF).
The matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. These risks are detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission including the Company's Annual Report, Quarterly Reports and other periodic filings. These forward-looking statements speak only as of the date hereof. The Company disclaims any intent or obligation to update these forward-looking statements.
ReoPro(R) is a registered trademark of Eli Lilly and Company. In the U.S., Centocor and Eli Lilly co-promote ReoPro. SOURCE Spectral Diagnostics Inc.
-0- 05/12/98 /CONTACT: Douglas C. Ball, Chairman and CEO of Spectral Diagnostics, 416-626-3233; or Irving L. Straus, Chairman of Straus Corporate Communications, 212-768-2477, for Spectral Diagnostics/
(DIAGF SDI.) CO: Spectral Diagnostics Inc. ST: Ontario IN: MTC SU:
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