Benzinga | Jul 22, 2021 12:50PM EDT

Chembio Diagnostics Receives $4M HIV Test Purchase Order Supported By The Global Fund

Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostic company focused on infectious diseases, announced its receipt today of a $4 million purchase order from the Partnership for Supply Chain Management (PFSCM), supported by The Global Fund, for the purchase of Chembio's HIV 1/2 STAT-PAK Assay for shipment to Ethiopia into early 2022. Chembio's delivery of the full number of tests covered by the purchase order may be affected by limitations of Chembio's supply chain, staffing, and liquidity, and other matters outside Chembio's control.



The HIV 1/2 STAT-PAK Assay is a World Health Organization (WHO) prequalified, rapid point-of-care assay for the detection of HIV-1 and HIV-2 antibodies in fingerstick whole blood, venous whole blood, serum, or plasma. With 99.7% sensitivity and 99.9% specificity, the HIV 1/2 STAT-PAK Assay is the only HIV test that exceeds WHO performance thresholds according to an independent, multi-site study published in the Journal of the International AIDS Society in 2017. Its innovative design can be performed in three simple steps with minimal training, requires only 5 microliters of blood, and includes a built-in biological control. A version of the HIV 1/2 STAT-PAK Assay for the U.S. market has received premarket approval (PMA) and a Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration.

"We are proud to continue our support of The Global Fund's pursuit of UNAIDS's '90-90-90' targets," said Richard L. Eberly, Chembio's President and Chief Executive Officer. "We look forward to working closely with PFSCM to continue the supply of our high-quality HIV tests to help the people of Ethiopia know their HIV status and obtain treatment."

Chembio was first awarded the front-line testing algorithm position in Ethiopia in 2018 to screen for HIV. With this latest purchase order, Chembio is continuing that important role, now under the contractual auspices of The Global Fund, and expanding its longstanding relationship with PFSCM, which leverages its planning and logistics resources for clients, governments, and nongovernmental organizations (NGOs) in over 85 countries.

Testing for HIV across Africa and Asia fell by 41% during the period from April to September 2020 compared to the same period in 2019, according to an April 2021 report by The Global Fund on the disruptive impact of the COVID-19 pandemic, despite The Global Fund's actions to continue essential HIV services and protect healthcare workers. The Joint United Nations Programme on HIV/AIDS (UNAIDS) has identified "90-90-90" targets under which 90% of HIV-positive people will know their status, 90% of HIV-positive people who know their status will be on HIV treatment, and 90% of people on HIV treatment will have achieved viral suppression and have undetectable levels of HIV in their bodies.