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Chembio Diagnostics Gets CLIA Waiver for HIV Test

Posted on: Monday, 5 November 2007, 12:00 CST

Chembio Diagnostics has received CLIA Waiver for its FDA-approved HIV Barrel test, a self-contained rapid HIV test that is marketed worldwide by Inverness Medical Innovations, as Clearview Complete HIV 1/2.

The CLIA (Clinical Laboratory Improvement Act) waiver allows Chembio to market these rapid HIV tests to a potential market of approximately 189,000 laboratory entities across the US, including doctor's offices and clinics.

A CLIA waiver expands the available potential US market opportunity for a product from sites that require much greater certification and oversight (i.e. reference laboratories and hospitals) to additional venues where point-of-care testing is particularly beneficial (i.e. emergency rooms, doctor's offices and public health clinics). The US Centers for Disease Control (CDC) has issued recommendations that HIV testing become part of the routine medical care provided to all Americans between the ages of 13 and 64.

Larry Siebert, CEO of Chembio, said: "This CLIA Waiver provides an excellent opportunity for our marketing partner, Inverness, to take advantage of the benefits inherent in the additional venues now available to Clearview Complete HIV 1/2. This, combined with the recent CDC recommendations for routine HIV testing in the US, provides the right market dynamics for Inverness to be successful with this product."

Source: Datamonitor

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