Healthcare Industry News:  ESTECH 

Diagnostics FDA

 News Release - July 12, 2007

FDA Grants CLIA Waived Status to Cholestech for New Combined Test Panel

Statin Prescribers in the US to Benefit from Lipid Profile and ALT in One Quick and Accurate Test

HAYWARD, Calif., July 12 (HSMN NewsFeed) -- CholESTECH Corporation (Nasdaq: CTEC ), a leading provider of alternate site health management solutions for chronic disease, announces that the FDA has granted CLIA waived status to the Company's newest test panel, Lipid Profile ALT. The new test panel, designed for use with the CholESTECH LDX System, combines an ALT test with a lipid profile, providing total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride and alanine aminotransferase (ALT) results from a single fingerstick.

By testing at the point of care, the Lipid Profile ALT test allows physicians in the US to immediately assess elevated cholesterol levels and liver damage at the same time allowing for medication dosage adjustments and safety monitoring on-the-spot.

In office testing improves patient adherence as a result of the strong impact of a face-to-face exchange between patient and physician as opposed to the delays associated with sending samples to off-site labs. The new test panel also increases office efficiency and patient comfort by cutting analysis time in half when compared to performing the tests separately -- results are generated from just one fingerstick and available within five minutes. Independent market research reveals that with the availability of the Lipid Profile ALT cassette, 61 percent of physicians will increase the amount of in-office testing they do.

"The new test panel provides physicians who are prescribing statins with valuable access to quick and accurate results for better management of patient adherence and side effects," said Warren E. Pinckert II, CholESTECH President and CEO. "The CLIA waiver that the FDA granted to the Lipid Profile ALT cassette provides physicians with confidence in the accuracy of the results they see for each and every patient."

About CLIA and CLIA Waiver

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 established quality standards for laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. CLIA waived tests are recognized by the FDA to be so simple to use and so accurate that there is little risk of error. As a result, those using CLIA waived tests are not subject to the more stringent and expensive requirements of moderate or high complexity laboratories.

Before running a waived test, a CLIA Certificate of Waiver must be obtained from the Centers for Medicare & Medicaid Services (CMS). CLIA requirements differ by state and for physician offices, pharmacies and hospitals. Contact your state CLIA office to learn about CLIA requirements for your health organization.

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 enzymes at the point of care. Health care providers can use the CLIA waived CholESTECH LDX and GDX(TM)* Systems and the hs-CRP test, which is cleared by the FDA for use in moderate complexity labs, 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, inflammatory disorders and diabetes. *The GDX system is 510(k) cleared for prescription home use and, accordingly, is CLIA waived.

CholESTECH LDX is a registered trademark and CholESTECH GDX is a trademark of CholESTECH Corporation. All other trademarks mentioned in this document are the property of their respective owners. For more information about CholESTECH and its products visit us on the web at

Source: Cholestech

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