Effective June 4, 2014, Chembio, Medford, NY, has announced the launch of its United States sales and marketing effort for its HIV 1/2 Stat-Pak assay and related HIV Rapid Test Control Pack, along with the company’s DPP HIV 1/2 assay and corresponding DPP HIV 1/2 Control Pack. The Stat-Pak assay was previously marketed in the US as the Clearview HIV 1/2 Stat-Pak assay, available through Alere.
The HIV 1/2 Stat-Pak assay is FDA-approved and CLIA-waived. According to the company, it has been one of the leading diagnostics used for HIV/AIDS since its market introduction in 2006. The test’s ease of use, 5-µL specimen requirement, rapid results, long shelf life, and room temperature storage make it suitable for clinical and outreach settings, allowing immediate patient counseling and referral.
The DPP HIV 1/2 assay detects HIV antibodies in oral fluid or blood and uses Chembio’s patented dual path platform technology for high sensitivity and specificity. A SampleTainer specimen collection bottle provides an enclosed system for collecting potentially infectious samples. The DPP HIV 1/2 assay is FDA-approved, with discussions underway with FDA concerning CLIA waiver. Initial marketing for the assay will be directed at CLIA moderate-complexity testing sites.
“We believe that Chembio has established a world-class sales and marketing organization,” said John Sperzel, Chembio’s CEO. “I’m confident that our US program will bring us closer to our customers and enable us to strengthen our position in the market. Our HIV 1/2 Stat-Pak assay is one of the most reliable and respected HIV diagnostics in the US, and we hope to leverage our reputation for quality and innovation as we introduce our proprietary dual path platform (DPP) diagnostics to the market.”
For more information, visit Chembio.
