Benzinga | Nov 29, 2021 08:05AM EST

Chembio Diagnostics Receives SAHPRA Approval For DPP SARS-CoV-2 Antigen Test

Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced receipt on November 26, 2021, of 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.

"We are pleased that independent evaluation of the DPP SARS-CoV-2 Antigen test again demonstrated strong sensitivity and specificity performance. This is another validation of the DPP technology that expands the regulatory approvals received by our COVID testing portfolio," said Richard Eberly, Chembio's President and Chief Executive Officer. "South Africa represents a large testing market opportunity. We are excited to provide our distributor, Patient Focus Africa (PFA), with another testing solution in addition to our DPP SARS-CoV-2 IgM/IgG Antibody test, to help manage the evolving needs of the pandemic in South Africa."

The DPP SARS-CoV-2 Antigen test has been designed to detect SARS-CoV-2 antigens in only 20 minutes. The DPP SARS-CoV-2 Antigen test uses a minimally invasive nasal swab and is designed to be read visually or with a DPP Micro Reader 2 optical analyzer. Both the DPP SARS-CoV-2 Antigen test and the IgM/IgG Antibody test are authorized for import and distribution in South Africa by Chembio's distributor, Patient Focus Africa, pursuant to licenses issued by SAHPRA. PFA is a World Health Organization accredited company for near patient testing, wellness, and professional point of care testing. PFA is partially owned by Discovery Health, the largest private healthcare Insurance provider in South Africa, and services both the public and private healthcare markets in the country.

"We have 22 years' experience of using quality point of care and rapid tests in the Southern African market. We have conducted millions of tests over this period of time. Let me state unequivocally: the Chembio DPP platform/test is in a league of its own. The quality control built into the strip, the ease of collecting quality samples, and the receipt of results that you can trust time after time -- this is truly lifesaving," said Jacques du Toit, Founder and Manager Director of Patient Focus Africa. "These sentiments are expressed and shared by our customers. Thank you Chembio for adding life to days; days to life!"