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FDA Grants CLIA Waived Status To Cholestech For New Combined Test Panel

Armen Hareyan's picture

FDA has granted CLIA waived status to the Company's newest cholesterol test panel.

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.

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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