CULVER CITY, Calif., Aug. 11, 1999 (PRIMEZONE) -- CARESIDE, Inc. (AMEX:CSA) announced submission of its CARESIDE(TM) CO2 blood test to the U.S. Food and Drug Administration (FDA). The test is expected to become part of the Company's CARESIDE Analyzer(TM) which will provide a cost-effective and efficient means of analyzing blood at the same location as the patient, and will produce accurate test results within 15 minutes.
The Company's carbon dioxide (CO2) test measures the total CO2 concentration in anti-coagulated blood, plasma, and serum. This test aids in the diagnosis and treatment of patients with conditions such as respiratory, kidney, and metabolic disorders.
Once its CO2 test is cleared, CARESIDE will be able to provide an additional test called Anion Gap. Anion Gap is a calculation incorporating electrolyte and the CARESIDE(TM) CO2 test results. This calculation aids in the diagnosis and treatment of a variety of conditions associated with changes in ion concentration like dehydration.
Chairman and CEO W. Vickery Stoughton explained that CO2 concentrations in blood change rapidly with exposure to the air. Therefore, the time between blood collection and blood testing can affect the CO2 test result. "Hospital labs typically take four to six hours to process a routine blood test. A commercial lab can take up to 24 hours. The CARESIDE Analyzer(TM)including the CO2 test, will produce accurate test results within 15 minutes," Mr. Stoughton said. "Consequently, the rapid nature of CARESIDE(TM)'s CO2 test will assure high quality test results for both CO2 and Anion Gap since both can be completed within minutes of the blood draw."
The Company expects this test to be cleared by the FDA for product launch in the fourth quarter of this year. CARESIDE has been averaging 59 days for test clearance from the date of submission. Nevertheless, the FDA can take 90 days to initially respond. Actual clearance may take longer.
CARESIDE, Inc., a blood diagnostic company based in Culver City, California, recently announced its initial public offering in June 1999. The company is developing a proprietary blood testing system including its CARESIDE Analyzer(TM) a blood diagnostic device, and accompanying record management software. The Company plans to manufacture and distribute the product to health care providers in the U.S and abroad. CARESIDE expects to launch its product in the fourth quarter of this year.
Safe Harbor: Statements in this press release regarding CARESIDE Inc. which are not historical facts are forward-looking statements that involve risks and uncertainties. Such forward-looking statements include the date of market launch, and the date of FDA clearance. Key factors which may impact on these statements include technological hurdles, FDA approval process, and other challenges inherent in product research, development, manufacturing, marketing, and other factors discussed in the Company's prospectus. The Company undertakes no obligation to update forward-looking statements. Please see the risk factors listed from time to time in the Company's prospectus and reports on file with the SEC.