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The coalition includes partners from all over the world, including universities, research centers, and health systems in South Asia, Africa, South America, and the US.
The firm's assay leverages reverse transcriptase quantitative PCR to amplify two separate regions of the HIV-1 genome to monitor HIV-infected patients.
The company's fourth quarter 2020 revenues were buoyed by sales of its SARS-CoV-2 testing-related products including transport media.
The agency said it strongly recommends the use of POC nucleic-acid testing to diagnose HIV in infants and children younger than 18 months.
The firm plans to expand the menu for its immunoassay reader, anchoring its US expansion to a novel dual test for HIV and syphilis.
The firm recently in-licensed distribution of an Emergency Use Authorized SARS-CoV-2 antigen assay it expects to launch in March 2021.
Prequalification from the World Health Organization indicates that products meet high quality standards and are safe for their intended use.
The firm attributed its quarterly and annual revenue gains primarily to sales of COVID-19 testing sample collection devices.
The company said that its Aptima HIV-1 molecular test utilizes a dual-target approach against highly conserved regions in the HIV genome.
Though its point-of-care revenues fell, the firm's clinical laboratory sales for the third quarter rose 44 percent over the prior-year quarter