Saturday, November 1, 2014

Chembio's DPP(R) HIV 1/2 Assay Receives CLIA Waiver From FDA

Chembio Diagnostics, Inc., a leader in point-of-care (POC) diagnostic tests and technology, today announced that the U.S. Food and Drug Administration (FDA) granted a CLIA Waiver for the Company's DPP® HIV 1/2 Assay. Chembio's DPP® HIV 1/2 Assay was FDA-approved previously, and the CLIA Waiver will allow Chembio to expand into important new channels that are closest to patient care including physician-office-lab (POL) facilities, clinics and other community healthcare providers.

Chembio's DPP® HIV 1/2 Assay detects HIV antibodies in oral fluid or blood and uses the Company's patented Dual Path Platform (DPP®) technology, which offers excellent sensitivity and specificity. The product's unique SampleTainer® specimen collection bottle is a safe, closed system for collecting potentially infectious samples. The DPP® HIV 1/2 Assay is one of only two FDA approved, CLIA-waived oral fluid HIV 1/2 rapid tests available in the U.S.

"Accurate diagnostic testing is an important tool in the battle against HIV/AIDS," stated John Sperzel, CEO of Chembio. "Our DPP® HIV 1/2 Assay combines excellent sensitivity and specificity, simple and safe oral fluid sample collection, and exceptional ease of use. We believe this combination will lead to more testing, which will result in increased detection, earlier treatment and lower exposure rates. We recently signed agreements with several major U.S. distributors for the DPP® HIV 1/2 and HIV 1/2 STAT-PAK® Assays and, with receipt of this latest waiver, we will expand our U.S. sales and marketing effort as planned."

The U.S. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 to establish standards for all laboratory testing and amended it in 2008 to establish more stringent guidelines for in-vitro diagnostics. CLIA standards require that only accurate and easy-to-use tests are performed in the physician's office. The FDA determines whether a device is CLIA-waived based on extensive evaluations conducted in a CLIA-waived environment by intended users such as physicians, nurses and medical assistants.

Chembio's DPP® HIV 1/2 and HIV 1/2 STAT-PAK® Assays are both manufactured in the U.S. by Chembio.

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