Feb. 10, 2016—Chembio Diagnostics will begin selling its Sure Check HIV 1/2 Assay in the U.S. market on June 1, 2016. The product is currently distributed in the U.S. by Alere under Alere’s Clearview Complete brand, and Chembio has notified Alere that it will not renew or extend the distribution agreement when it terminates May 31, 2016.
The Sure Check HIV 1/2 Assay is FDA-approved, CLIA-waived, CE-marked, and has been prequalified by the World Health Organization. Assay results are obtained in 15 minutes only a 2.5uL blood sample (fingerstick, serum, plasma, or venipuncture whole blood). The assay is stable at room temperature and provides 99.7 percent sensitivity and 99.9 percent specificity.
“Today’s announcement concerning termination of the U.S. distribution agreement with Alere, effective May 31, 2016, affirms our intent to gain full global rights related to the Sure Check HIV 1/2 Assay, including sales, marketing, distribution, and trademark rights,” Chembio CEO John Sperzel said in a statement. “The Sure Check HIV 1/2 Assay is a high-quality, well-respected product and we look forward to marketing and selling the product in the U.S. market.”