Cardiovascular Diagnostics Announces Start of Collaborative European Phase III Trials With LRF Test to Monitor Knoll's Ancrod.

RALEIGH, N.C.--(BW HealthWire)--Sept. 23, 1998--Cardiovascular Diagnostics, Inc. (NASDAQ: CVDI) ("CVDI") today announced that the Company has completed initial development of a new dry chemistry test, the Low Range Fibrinogen ("LRF") test, to monitor the treatment of ischemic stroke with Knoll AG's ("Knoll") new agent Ancrod(R).

CVDI and Ludwigshafen, Germany-based Knoll have started field trials with the LRF test in Germany, Switzerland, Spain, The Netherlands and the U.K.

CVDI's test will be used to monitor the fibrinogen levels of patients receiving Ancrod and the data collected will be used, in part, for a submission to European regulatory authorities. Ancrod, a purified compound developed from the venom of the Malayan pit viper (Calloselasma rhodostoma), removes fibrinogen, a natural protein that augments clot formation, from the blood.

More than 1.6 million people in the U.S. and Europe are afflicted by stroke each year, of which approximately 80% are caused by a blood clot. Stroke is the No. 1 cause of disability in the U.S. and is the third leading cause of death. The annual cost to the U.S. healthcare system to treat and rehabilitate stroke victims is estimated to be in excess of $30 billion.

The LRF test is the second test CVDI has developed for use by Knoll to monitor new, highly potent drugs that may require individual dose adjustment. Without proper monitoring of these types of compounds, the physician could be at risk of over- or under-dosing the patient. Rapid bedside monitoring is particularly useful to be able to adjust therapy to changing patient conditions, and should result in improved efficacy and safety, thereby reducing total healthcare costs.

The development agreement between CVDI and Knoll was signed in May 1997 and provides for milestone payments already received by CVDI. Commenting on the progress of the collaboration to date, John Funkhouser, CVDI's president and CEO, said, "The speed with which we have brought this test from concept to reality clearly illustrates our ability to use the flexibility of our TAS (Thrombolytic Assessment System) technology platform in developing products to rapidly monitor numerous therapeutics effecting coagulation. We will continue to use this technological advantage in implementing our strategy of partnering with other pharmaceutical companies that are seeking ways to expedite the drug development process."

Mr. Funkhouser stated, "This latest test adds to our extensive menu of products, and strengthens our position as a leader in the field of enabling technologies for use by pharmaceutical companies and physicians in the development and monitoring of new, emerging therapeutics."

Patrick Mize, Ph.D., senior scientist at CVDI, added, "Each new test we develop increases our understanding of the impact of these compounds on the coagulation process, and leads to discoveries that may help in our programs to research and develop tests for other anticoagulant compounds. In addition, these new tests may have application in other clinical areas. For example, this test for monitoring Ancrod's effect on fibrinogen may also be useful in developing a test to monitor the level of fibrinogen during lengthy surgical interventions, such as in coronary bypass surgery."

CVDI recently announced the initiation of field trials with a Sepsis Marker test being developed under another collaborative agreement. The Company also has a 510(k) regulatory submission under review at the U.S. Food and Drug Administration for an Ecarin Clotting Time ("ECT") test developed to monitor the effect of Knoll's therapeutic PEG-Hirudin.

Cardiovascular Diagnostics, Inc. develops, manufactures and markets rapid turnaround diagnostics to assess blood clot formation and dissolution. The Company develops tests based on its proprietary, dry chemistry TAS for its principal target market of powerful new drug compounds, some of which have narrow therapeutic ranges, as well as for monitoring routine anticoagulants. The Company's therapeutic diagnostics are used in the treatment of angina, myocardial infarction (heart attack), stroke, deep venous thrombosis, and pulmonary and arterial emboli.

This press release contains forward-looking statements regarding future events and the future performance of the Company 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.