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 | Make a Comment

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.

Posted In: News Penny Stocks Health Care FDA Movers Trading Ideas General Briefs

Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.