ACCESS BIO, INC
Access Bio’s mission is to improve the lives and well-being of people around the world through the development of in vitro diagnostics technology. They are a trusted partner to international public health agencies and organizations, focusing on the diagnosis and prevention of infectious diseases, including malaria, HIV, HPV, and COVID-19. The company emphasizes innovation, quality control, and global health impact, with a vision to be a global pioneer in in vitro diagnostic technologies and to promote health and well-being through accurate disease diagnosis.
Industries
Nr. of Employees
small (1-50)
Products
At-home lateral-flow COVID-19 antigen test (anterior nasal)
A lateral-flow immunoassay kit for qualitative detection of SARS-CoV-2 nucleocapsid antigen using self-collected anterior nasal swabs, intended for non-prescription home use with mobile app interpretation support.
Point-of-care lateral-flow COVID-19 antigen test
A lateral-flow immunoassay intended for point-of-care use to detect SARS-CoV-2 antigens from nasopharyngeal specimens with rapid visual readout.
RT-PCR molecular diagnostic kits
Real-time PCR and RT-PCR kits for laboratory molecular detection and genotyping of viral pathogens (examples include kits for Zika, Dengue, HPV, scrub typhus).
Serology lateral-flow IgM/IgG test (fingerstick)
Rapid serology lateral-flow assay that differentiates IgM and IgG antibodies from small-volume whole blood, serum or plasma with a 10-minute readout.
Malaria and other infectious-disease rapid diagnostic tests (RDTs)
Rapid diagnostic tests for malaria and other infectious diseases designed for use in field and low-resource settings.
POC analyzer and assay cartridges
Small analyzer devices and single-use cartridges for biochemical and immunoassay measurements such as A1c, CRP, and ACR.
At-home lateral-flow COVID-19 antigen test (anterior nasal)
A lateral-flow immunoassay kit for qualitative detection of SARS-CoV-2 nucleocapsid antigen using self-collected anterior nasal swabs, intended for non-prescription home use with mobile app interpretation support.
Point-of-care lateral-flow COVID-19 antigen test
A lateral-flow immunoassay intended for point-of-care use to detect SARS-CoV-2 antigens from nasopharyngeal specimens with rapid visual readout.
RT-PCR molecular diagnostic kits
Real-time PCR and RT-PCR kits for laboratory molecular detection and genotyping of viral pathogens (examples include kits for Zika, Dengue, HPV, scrub typhus).
Serology lateral-flow IgM/IgG test (fingerstick)
Rapid serology lateral-flow assay that differentiates IgM and IgG antibodies from small-volume whole blood, serum or plasma with a 10-minute readout.
Malaria and other infectious-disease rapid diagnostic tests (RDTs)
Rapid diagnostic tests for malaria and other infectious diseases designed for use in field and low-resource settings.
POC analyzer and assay cartridges
Small analyzer devices and single-use cartridges for biochemical and immunoassay measurements such as A1c, CRP, and ACR.
Services
Establishment and management of national and international distribution agreements and channel partnerships to commercialize diagnostic products.
Preparation and provision of regulatory documentation packages, instructions for use, and EUA-related materials for diagnostic products.
Establishment and management of national and international distribution agreements and channel partnerships to commercialize diagnostic products.
Preparation and provision of regulatory documentation packages, instructions for use, and EUA-related materials for diagnostic products.
Expertise Areas
- Rapid diagnostic test development
- Molecular diagnostics (RT-PCR) development
- Point-of-care and at-home diagnostics
- Analyzer and cartridge-based platform development
Key Technologies
- Lateral-flow immunoassays
- RT-PCR / real-time PCR
- Biosensor-based assays
- Cartridge-based analyzer platforms
News & Updates
The at-home kits were divvied up and picked up by 19 different school districts in Erie County for distribution.
Based on sequence analysis and Omicron recombinant protein test, Omicron variant does not influence the target region of CareStart™ COVID-19 Rapid and PCR Tests.
The record date for determining shareholders in 2020 is December 31, 2020, in accordance with the Korean Depository Receipt Agreement.
Emergency Use Authorization granted for CareStart™ Point-Of-Care Kit.
FDA EUA granted for CareStart™ COVID-19 IgM/IgG antibody test, manufactured entirely in the USA.
The at-home kits were divvied up and picked up by 19 different school districts in Erie County for distribution.
Based on sequence analysis and Omicron recombinant protein test, Omicron variant does not influence the target region of CareStart™ COVID-19 Rapid and PCR Tests.
The record date for determining shareholders in 2020 is December 31, 2020, in accordance with the Korean Depository Receipt Agreement.
Emergency Use Authorization granted for CareStart™ Point-Of-Care Kit.
FDA EUA granted for CareStart™ COVID-19 IgM/IgG antibody test, manufactured entirely in the USA.