Cholestech Introduces High Sensitivity C-Reactive Protein Test For Physician Office Use

ORLANDO, Fla., March 7 /PRNewswire-FirstCall/ -- Cholestech Corporation , a leader in physician office testing, today announced the introduction of the Cholestech LDX(R) high sensitivity C-Reactive Protein (hs-CRP) test here at the 54th Annual Scientific Session of the American College of Cardiology (ACC), March 6-10. Cholestech has received clearance from the US Food & Drug Administration to market the hs-CRP test on the LDX System for the measurement of CRP in whole blood or serum. It will be available in the summer of 2005.

CRP is a systemic marker of inflammation and the measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. Conventional CRP assays have been optimized to facilitate measurement of dynamic increases in concentration associated with acute infections or chronic inflammations, such as rheumatoid arthritis. However, this limits the ability to detect low level increases due to more subtle causes of inflammation.

In a study presented at the 2004 International Symposium on Critical Care and Point-of-Care Testing in Wurzburg, Germany, researchers demonstrated that the Cholestech LDX hs-CRP test provides a rapid method for highly sensitive determination of CRP levels from a single drop of blood.

“We are proud to expand the utility of the LDX System, already the leading physician’s office based cholesterol monitoring tool, to include this important tool for inflammatory diseases,” said Warren E. Pinckert II, president and CEO of Cholestech. “Adding hs-CRP to the ability to obtain a full lipid profile and monitor liver enzymes with both ALT and AST, the LDX platform offers physicians the broadest available capabilities to monitor chronic disease.”

The Cholestech hs-CRP test can be performed on the LDX System. Generating comprehensive, lab accurate results in 6 minutes, the Cholestech LDX platform also supports the measurement of cholesterol and liver enzymes. Using a single drop of blood, the test measures a patient’s lipid profile to determine overall cholesterol levels and the patient’s risk of heart disease. Two liver enzyme tests, ALT and AST, provide quantitative measurements to assess the potential for liver damage resulting from therapy with certain drugs and other clinical conditions.

About Cholestech

Cholestech is committed to enabling people to lead longer, healthier and more active lives. Cholestech provides easy to use, accessible diagnostic tools and information to health care practitioners in over 35 countries around the world. Cholestech offers efficient and economic diagnostic testing for cholesterol and related lipids, blood glucose and glycemic control, and liver function at the point of care. Health care providers can use the CLIA-waived Cholestech LDX(R) and GDX(TM) Systems to initiate and monitor the progress of patient therapy. By providing effective disease management solutions, Cholestech’s goal is to be a leading provider of diagnostic tools and information for immediate risk assessment and therapeutic monitoring of heart disease and diabetes.

Cholestech Corporation

CONTACT: Warren E. Pinckert II, President and Chief Executive Officer,Cholestech Corporation, +1-510-732-7200, wpinckert@cholestech.com; or Chris K.Joseph of ckj Communications, +1-510-339-2293, chris@ckjcomm.com, forCholestech Corporation