Access Bio, Inc.

Access Bio, Inc. is a global in vitro diagnostics (IVD) manufacturer headquartered in Monroe Township, New Jersey. The company specializes in rapid diagnostic tests and molecular diagnostics for infectious disease detection, with a primary focus on malaria, HIV, HPV, and COVID-19. Access Bio's product portfolio includes rapid point-of-care tests, COVID-19 antigen and molecular (PCR) assays, serology tests, and automated laboratory analyzers. The company has received multiple FDA Emergency Use Authorizations (EUA) for COVID-19 detection kits, including a 10-minute antigen test and molecular tests with results in 83 minutes or less. Access Bio serves international public health agencies, healthcare systems, and research organizations globally. The company holds FDA regulatory approvals and maintains manufacturing and distribution capabilities through established supply chain partnerships. Recent regulatory milestones include FDA-granted shelf-life extensions for the CareStart COVID-19 Antigen Home Test (extended to 21 months at 1–30°C storage). Access Bio is positioned as a leader in infectious disease diagnostics with operations across the US, South Korea, and other international markets. The company actively pursues partnerships with healthcare providers, educational institutions, and global health organizations to expand access to diagnostic solutions.