More details on the troponin I FDA approval
TORONTO, Nov. 11, 1996 -- Spectral Diagnostics Inc. (Nasdaq: DIAGF; Toronto: SDI), has received Food and Drug Administration (FDA) 510(K) marketing clearance for its Cardiac STATus(TM) rapid format Troponin I panel test, the industry's first point of care rapid troponin I assay.
Spectral's rapid format Troponin I panel test has been shown to be a very sensitive test for myocardial infarction and as recently published in The New England Journal of Medicine (N Engl J Med 1996;335:1342-9), cardiac troponin I levels provide useful prognostic information in patients with acute coronary syndromes and permit the early identification of patients with an increased risk of death.
The Cardiac STATus(TM) Troponin I rapid format panel test is for use in emergency rooms, critical care units, point of care, and other hospital settings. No additional instrumentation is required. The qualitative hand-held Cardiac STATus(TM) Troponin I panel test uses whole blood, serum or plasma. Results appear within minutes.
This week, the Distinguished Professor and internationally acclaimed cardiologist, Professor Christian W. Hamm, University Hospital Eppendorf, Hamburg, Germany is presenting abstracts at the Annual Meeting of the American Heart Association on his prospective clinical trial of 890 consecutive patients presenting to emergency departments using Spectral's rapid format Troponin I panel test. This trial demonstrated that Spectral's Troponin I panel test was more sensitive to detect early and minor myocardial injury than rapid format Troponin T. Spectral's rapid format Troponin I panel test performed with 97% sensitivity versus 89% sensitivity for rapid format Troponin T. From the same prospective trial it was determined that a qualitative determination from Spectral's rapid format Troponin I panel test has a 98% correlation to a traditional instrument-based quantitative determination, according to Professor Hamm.
In making the announcement, Douglas C. Ball, Chairman and CEO, said, "Having FDA clearance to market the first rapid format Troponin I panel test represents an important commercial milestone for the Company. According to last week's articles appearing in The New England Journal of Medicine, Troponins (T&I) were confirmed to be useful in identifying patients with acute coronary syndromes. Professor Hamm's study has established Spectral's Troponin I panel test as a more sensitive marker."
Located in Canada, the United States and Europe, Spectral's scientists, sales and marketing organizations and other professionals are focused on the development, manufacturing and commercialization of its Cardiac STATus(TM) line of 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 - NNM - 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.
Spectral's common shares are listed on the NASDAQ Exchange (Symbol - DIAGF) in the United States and the Toronto Stock Exchange "TSE" in Canada (Symbol - SDI). |
