(By Balachander) Chembio Diagnostics Inc. (NASDAQ: CEMI) shares are spiking in early Friday trading after the U.S. health regulators approved its new test to detect HIV-1/2 antibodies in either oral fluid or blood samples.
The U.S. Food and Drug Administration (FDA) cleared Chembio's Dual Path Platform (DPP) HIV 1/2 assay, allowing the company to market a point-of-care (POC) oral fluid rapid diagnostic test.
Chembio said it expects to launch DPP HIV 1/2 in the U.S. during the second half of 2013.
The company believes the new rapid diagnostic test has superior performance compared with the only other oral fluid HIV rapid test on the market.
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The diagnostic assay, the company said, uses the patented DPP technology for the rapid detection of HIV 1 and HIV 2 antibodies in all blood matrices and oral fluid.
The Chembio DPP HIV 1/2 Assay is a single-use immuno-chromatographic, rapid test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1/2) in oral fluid, finger-stick whole blood, venous whole blood, serum, or plasma samples.
According to the company, DPP enables samples to bind directly with target analytes before detection reagents are introduced to visualize the test results, and can improve accuracy compared with the current lateral flow HIV test technologies
The stock, which has been trading in the 52-week range of $2.96 to $5.78, traded 18.89 percent higher at $5.47 on Friday.