Access Bio

Access Bio is a commercial-stage diagnostics company with a 20+ year history focused on combating infectious diseases in global health settings. It successfully leveraged its IVD platform to become a significant player in the COVID-19 response, securing multiple FDA Emergency Use Authorizations (EUAs) for antigen, antibody, and molecular tests under its CareStart™ brand. While COVID-19 products were a major recent focus, the company's core expertise and legacy are in malaria and other serious tropical diseases, supplying tests to organizations in low-resource regions. The company appears to have a public listing via Korean Depository Receipts (KDRs), indicating a complex corporate structure with operations in the US and South Korea.

In vitro diagnostics (IVD) platform specializing in lateral flow immunoassays (rapid tests), analyzers/digital readers, and molecular diagnostics (PCR).

Access Bio competes in two main arenas: in global health diagnostics for malaria/HIV against companies like Abbott, SD Biosensor, and Premier Medical Corporation; and in the broader COVID-19/respiratory testing market against giants like Abbott, Roche, QuidelOrtho, and Becton Dickinson. Its niche is providing cost-effective, reliable tests suitable for low-resource and point-of-care settings.