Test Aiding in Diagnosis and Treatment of Liver Diseases including Hepatitis Will Make CARESIDE Analyzer(tm); First Diagnostic Device Providing Rapid Direct Bilirubin Result
CULVER CITY, Calif., Nov. 16, 1999, (PRIMEZONE) -- CARESIDE, Inc. (AMEX:CSA) (AMEX:CSAW) announced today submission of its CARESIDE(tm) Direct Bilirubin blood test to the U.S. Food and Drug Administration (FDA). When this test clears, CARESIDE(tm) believes its CARESIDE Analyzer(tm) will be the first diagnostic device capable of providing a rapid Direct Bilirubin result.
This specific test measures the concentration of Direct Bilirubin in anti-coagulated blood, plasma, and serum. A Direct Bilirubin test is frequently a follow-up test ordered after a Total Bilirubin test, which is a component of the comprehensive and hepatic test panels. This test is important because it aids in the diagnosis and treatment of patients with disorders such as hepatitis and gall bladder blockage. It is estimated that there are more than 4 million persons in the U.S. that have chronic hepatitis B or C, and there are more than 300,000 new infections diagnosed annually. Other forms of hepatitis make these numbers even larger.
The Company anticipates that the test will become part of its CARESIDE Analyzer(tm) which provides a cost-effective and efficient means of analyzing blood at the same location as the patient, and produces accurate test results within 15 minutes.
The Company expects the Direct Bilirubin test to be cleared by the FDA in early 2000. CARESIDE has been averaging 59.8 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., based in Culver City, California, 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. Product launch is expected in December 1999.
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 FDA clearance, and producing the first small medical device to provide Direct Bilirubin. 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.