Opting not to extend its current assay distribution agreement with Alere Inc, Waltham, Mass, Chembio Diagnostics Inc, Medford, NY, will begin selling its Sure Check HIV 1/2 assay in the US market on June 1, 2016.

Since 2006, Alere has exclusively handled US distribution of the assay under its Clearview Complete brand. Chembio recently notified Alere that it will not renew or extend the agreement upon its expiration on May 31, 2016. After that date, Chembio will begin selling the Sure Check HIV 1/2 assay in the US market through its existing sales force and distribution channels.

The FDA-approved assay has waived status under the Clinical Laboratory Improvement Amendments of 1988, and has been prequalified by the World Health Organization.

Assay results are obtained in 15 minutes using a 2.5 µL blood sample, obtained from fingerstick, serum, plasma, or venipuncture whole blood. The assay is stable at room temperature and provides 99.7% sensitivity and 99.9% specificity.

John J. Sperzel III, Chembio Diagnostic Systems.

John J. Sperzel III, Chembio Diagnostic Systems.

“Today’s announcement concerning termination of the US distribution agreement with Alere . . . affirms our intent to gain full global rights related to the Sure Check HIV 1/2 assay, including sales, marketing, distribution, and trademark rights,” says John Sperzel, CEO of Chembio.

For more information, visit Chembio.