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Chembio to Start Selling SURE CHECK® HIV 1/2 Assay in the US as of June 1, 2016

Vivien Diniz
Jan. 26, 2016 08:26AM PST
Medical Device Investing

Chembio Diagnostics, Inc. (NASDAQ:CEMI) announced that it will start selling its SURE CHECK® HIV 1/2 Assay in the US. market on June 1, 2016.

Chembio Diagnostics, Inc. (NASDAQ:CEMI) announced that it will start selling its SURE CHECK® HIV 1/2 Assay in the US. market on June 1, 2016.
According to the company’s press release:

The product is currently distributed in the U.S. by Alere, Inc. under Alere’s Clearview® COMPLETE brand (“Alere”), and Chembio has notified Alere that Chembio will not renew or extend the U.S. SURE CHECK® HIV 1/2 Assay distribution agreement when the agreement terminates, effective May 31, 2016.
The SURE CHECK® HIV 1/2 Assay is Food & Drug Administration (FDA) approved, CLIA-waived, European CE-marked, and has been pre-qualified by the World Health Organization (WHO).  Assay results are obtained in 15 minutes using only a 2.5uL blood sample (i.e., fingerstick, serum, plasma, or venipuncture whole blood). The assay is stable at room temperature and provides 99.7% sensitivity and 99.9% specificity.

John Sperzel, Chembio’s Chief Executive Officer, commented:

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. 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, effective June 1, 2016

Click here to view the full press release.

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