Subj: Quantech Ltd. Announces FDA 510(k) Submission For...
Date: 4/29/1998 1:56:07 PM Eastern Daylight Time
From: AOL News
BCC: Hebinc
Quantech Ltd. Announces FDA 510(k) Submission For Myoglobin Cardiac Test
ST. PAUL, Minn., April 29 -- Quantech Ltd. (OTC Bulletin Board: QQQQ) today announced that it has filed a 510(k) pre-market clearance with the U.S. Food and Drug Administration (FDA) on its test for the detection and quantification of the cardiac marker myoglobin. This cardiac marker is an aid to physicians in the diagnosis of an early stage heart attack. Myoglobin represents the first test for Quantech's multi-test system which will have capabilities for both single tests and clinically relevant test panels. Tests for the cardiac markers CK-MB and Troponin and the pregnancy marker hCG are currently under development.
"Submission to the FDA represents the achievement of a number of significant technical milestones over the last six months" said Robert Case, CEO of Quantech. "The speed from the time myoglobin development began until this submission reflects the robust nature of Quantech's technology and the exceptional abilities of our development team. By leveraging our technology base, Quantech expects to quickly and cost effectively develop additional critical care tests for its system. We continue to build further evidence that Quantech has an extremely versatile diagnostic platform that will provide true multi-test capability in hospital critical care units."
Based in St. Paul, Minn., Quantech is seeking to commercialize its surface plasmon resonance (SPR) technology for the medical diagnostic market. The company's diagnostic system is designed for hospital critical care units, initially the emergency department, to provide rapid quantitative tests. Quantech's first tests will be used for detecting and quantifying cardiac markers which aid physicians in assessing whether a patent has suffered a heart attack. Additional tests will be made available, allowing the system to provide a complete menu of clinically related, quantitative whole blood tests on a single instrument near the patient in 10 to 20 minutes.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: Any statements which are not historical facts contained in this release are forward looking statements that involve risk and uncertainties, including but not limited to those relating to product demand, pricing, market acceptance, the effect of economic conditions, the validity and enforceability of intellectual property rights, the outcome of government regulatory proceedings, competitive products, risks in product and technology development, the ability to complete transactions, and other risks identified in the Company's Securities and Exchange Commission filings.
SOURCE Quantech Ltd.
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