CEMI - Chembio Diagnostics jumps 10% after securing SAHPRA approval for DPP COVID-19 antigen test
Chembio Diagnostics (NASDAQ:CEMI) gains 9.5% premarket after receiving South Africa Health Products Regulatory Authority (SAHPRA) approval for the DPP SARS-CoV-2 Antigen test, authorizing marketing and distribution of the test for use at the point-of-care by professional healthcare providers. The DPP SARS-CoV-2 Antigen test has been designed to detect SARS-CoV-2 antigens in only 20 minutes. Chembio’s portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System. Additionally, DPP-based tests have received regulatory approvals from the World Health Organization, CE-Mark, ANVISA, and other global organizations, where they aid in the detection and diagnosis of several other critical diseases and conditions.
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Chembio Diagnostics jumps 10% after securing SAHPRA approval for DPP COVID-19 antigen test