Chembio Diagnostics has received a CLIA Waiver for its FDA-approved HIV Barrel test – a self contained rapid HIV test that is marketed worldwide by Inverness Medical Innovations under the brand name Clearview.
The CLIA waiver allows the companies to market the test to more than 189,000 laboratory settings across the U.S. The waiver greatly expands the market opportunity to venues where point-of-care testing is particularly beneficial including emergency rooms, doctor’s offices and public health clinics.
Inverness and Chembio’s long- term partnership specifies an equal share of profits after reimbursement of manufacturing and related costs. In addition, Inverness has rights to any future tests developed using Chembio’s proprietary Dual Path Platform technology.
Larry Siebert, CEO of Chembio, commented, “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(R) COMPLETE HIV 1/2. This, combined with the recent CDC recommendations for routine HIV testing in the United States, provides the right market dynamics for Inverness to be successful with this product.”
The United States 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.