Chembio Receives FDA Clearance for Breakthrough HIV Assay

A breakthrough point-of-care HIV assay from Chembio Diagnostics Inc. has received FDA approval, bringing the company a step closer to commercial launch of the test, the company announced. Chembio’s Dual Path Platform (DPP) assay is the only oral fluid rapid diagnostic in the United States that does not use flow-through technologies, according to the company. Because the technology enables samples to bind directly with target analytes before the introduction of detection reagents, the test is more accurate than current lateral-flow assays for HIV diagnosis, Chembio says. The PMA acceptance marks the first approval of a DPP-based assay by FDA.
The test is designed for preliminary diagnosis of patients with HIV in a range of POC settings, Chembio says. Developed for patients two years of age and older, the test detects antibodies to HIV 1 and 2 in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The result is presented in a reactive/nonreactive form.
Chembio says approximately 2800 patients have participated in a multi-site study in five clinical settings, including a pediatric hospital, to determine the assay’s diagnostic sensitivity. The results showed a 99.8% sensitivity for fingerstick samples and 99.9% sensitivity for venous whole blood, serum, and plasma samples, according to the company. Detection sensitivity for oral fluid samples was 98.9%.
Based in Medford, NY, Chembio received a patent for DPP in 2007. In a June 2010 interview with MX:Medtech Executive, Larry Siebert, CEO, said the technology is a big improvement over existing diagnostic platforms: “We consider our DPP technology a breakthrough and an advance in the detection of many conditions, including, but not limited to, HIV/AIDS. Standard lateral-flow technology has some limitations when it comes to the use of oral fluid samples, or in multiplexing, to features that we believe our DPP technology enables more effectively.”
Chembio’s next move is to submit the results of CLIA waiver trials to prepare the ground for commercial launch of the DPP-based HIV 1 and 2 assay in the U.S. CLIA submission is scheduled for the first half of 2013 with an eye toward launching the product in the second half of the year.
---John Conroy