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FOR IMMEDIATE RELEASE
October 21, 1998
CARDIOVASCULAR DIAGNOSTICS, INC. PROVES FEASIBILITY FOR A TEST TO EVALUATE A NEW SEPSIS DRUG UNDER DEVELOPMENT BY ELI LILLY AND COMPANY
RALEIGH, NC -- October 21, 1997 -- Cardiovascular Diagnostics, Inc. (Nasdaq:CVDI) today announced that it has successfully completed proving feasibility for a new dry chemistry test to evaluate the effect of a therapeutic anticoagulant (“TA”) currently in Phase II clinical trials at Eli Lilly and Company (“Lilly”) (NYSE:LLY) for the treatment of sepsis. This successful outcome represents a significant scientific milestone for CVDI and demonstrates the flexibility of the Company’s Thrombolytic Assessment System (TAS™) technology to produce a rapid diagnostic test in a dry chemistry format.
Sepsis is a condition caused by pathogens circulating in the blood that can result in serious complications such as organ failure. With a 30% to 50% mortality rate, sepsis is the 13th most frequent cause of death in the United States, and the intensive management of affected patients is estimated to cost the U.S. healthcare system in excess of $5 billion to $10 billion per year.
The milestone goal for CVDI was to reduce to the Company’s dry chemistry format the existing laboratory test which it had previously developed in a wet chemistry format. The advantage of a dry chemistry test is its ease of use and ability to provide a much more rapid test result. Lilly’s TA will be used in those critical care areas of the hospital which require rapid turnaround of diagnostic results to improve patient care and turnover. Successful demonstration of CVDI’s technology concluded with a parallel analysis by CVDI and Lilly of standard curves of the analyte constructed in a base of diluted, pooled, normal human plasma. As expected, the dry chemistry format of the test card duplicated the characteristics and low variability defined by the wet chemistry format, thereby proving feasibility.
The second scientific milestone of the project will involve further testing of patient samples in order to define the test parameters. As a result, CVDI expects that they may have to adjust their dry chemistry formulation to compensate for any potential interferences.
Proving feasibility and demonstrating the ability of the test to evaluate the levels of this sepsis marker in the targeted patient population are the critical milestones in developing a dry chemistry, rapid diagnostic test. This ongoing collaboration with Lilly is part of CVDI’s corporate strategy to provide rapid diagnostic tests for new developmental drugs with narrow therapeutic windows.
Cardiovascular Diagnostics, Inc. develops, manufactures and markets systems designed to deliver rapidly and accurately, blood test results at the point-of-care (“POC”). CVDI’s novel technology platform has allowed the Company to develop a menu of diagnostic tests, including new specialty tests. The Company believes that its Thrombolytic Assessment System (“TAS”) technology is the only POC system capable of monitoring both the formation and dissolution of blood clots -- a critical factor in treating heart attacks, strokes and a variety of other medical conditions.
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To receive CVDI’s latest news release and other corporate documents via FAX- no cost-please dial 1-800-PRO-INFO. Use company’s ticker, CVDI. Or visit The Financial Relations Board’s web site at http://www.frbinc.com.
This press release contains forward-looking statements regarding future events and the future performance of Cardiovascular Diagnostics that involve risks and uncertainties that could cause actual results to differ materially from those projected in the forward-looking statements. Information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in the Company’s SEC filings, including Form 10-K, Form 10-Q and Form 8-K reports.
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