FDA Asks Chembio Additional Data On HIV-Syphilis Test For CLIA Waiver

by Vandana Singh, Benzinga Editor

December 8, 2021 1:25 PM | 1 min read |

Chembio Diagnostics Inc's CEMI said that on December 1, it received an FDA notice for additional data related to Clinical Laboratory Improvement Amendment (CLIA) waiver submission for the DPP HIV-Syphilis test system.
In the SEC filing, the Company notes that seeking additional data will extend, for a currently undeterminable period, the process for seeking a CLIA waiver for the DPP HIV-Syphilis test system.
Also, the BARDA contract dated December 2, 2020, expired under its terms on December 2, 2021.
Chembio earned a total of $12.5 million in grant income under the BARDA Agreement of the $12.7 million available.
Also See: Chembio Diagnostics' DPP COVID-19 Antigen Test Approved In South Africa.
Price Action: CEMI shares are down 0.27% at $1.82 during the market session on the last check Wednesday.

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