CULVER CITY, Calif., Jan. 23, 2002 (PRIMEZONE) -- Careside Inc. (AMEX:CSA) (AMEX:CSA.W), a provider of point-of-care (POC) blood analysis instrumentation and records management systems, announced today submission of its Careside activated partial thromboplastin time (APTT) blood coagulation test to the U.S. Food and Drug Administration (FDA).
The newly submitted APTT test is used to evaluate one of the two cascades in the blood coagulation system and, together with Careside's prothrombin time (PT) coagulation test, will offer physicians and laboratory professionals rapid results to over 90 percent of all coagulation tests performed. Careside's APTT test uses an unprocessed whole blood sample and is equivalent in all respects to traditional laboratory APTT tests. APTT is widely used to provide critical information about the presence and activity of factors that are required for proper clotting and for the therapeutic monitoring of anticoagulation therapy using heparin. Accordingly, APTT testing is important before and after many surgical procedures and as part of the diagnosis and treatment of a wide variety of clotting-related disorders.
The company expects its APTT test to be cleared by the FDA in the second quarter in 2002. Careside has been averaging 60 days for test clearance from the date of submission. Nevertheless, the FDA can take 90 days to initially respond. Actual clearance may take longer.
The CARESIDE Analyzer offers the broadest test menu in the point-of-care instrument market, with 41 FDA-cleared or exempt tests in the categories of chemistry, electrochemistry, hematology and coagulation. "Careside looks forward to APTT's market introduction as another important step forward in completing Careside's mission to provide on a single platform all of the tests physicians commonly use to provide care for both inpatients and outpatients," said W. Vickery Stoughton, Careside Chairman and CEO.
The compact, desktop CARESIDE Analyzer provides clinicians with accurate, cost-effective results for individual tests in just 4 to 12 minutes, much more quickly than typical results delivered by a hospital or reference laboratory. The instrument's test menu encompasses the majority of tests most commonly ordered by clinicians. FDA clearance of the APTT test will increase the CARESIDE Analyzer's test menu to 42.
Safe Harbor: Statements in this press release regarding Careside Inc. that are not historical facts are forward-looking statements that involve risks and uncertainties. Such forward-looking statements include the date of FDA clearance for APTT. Key factors that 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.