Access Bio
Access Bio is a developer and manufacturer of in vitro diagnostic tests focused on infectious diseases (malaria, HIV, HPV, SARS-CoV-2). The company designs and commercializes rapid lateral-flow assays, serology tests, and molecular (real-time RT‑PCR) diagnostics; operates R&D and production facilities in the United States, South Korea and Ethiopia; distributes products to 120+ countries; and has obtained regulatory emergency authorizations for multiple COVID-19 diagnostics.
Industries
Nr. of Employees
medium (51-250)
Patents
Single-pad strip for an improved lateral flow assay and a test device using the same
US-10048251-B2
View DetailsSingle-pad strip for an improved lateral flow assay and a test device using the same
US-9575056-B2
View Details
Single-pad strip for an improved lateral flow assay and a test device using the same
US-10048251-B2
View DetailsSingle-pad strip for an improved lateral flow assay and a test device using the same
US-9575056-B2
View DetailsProducts
Point-of-care antigen lateral-flow tests
Single-use lateral-flow assays for rapid detection of viral antigen at point-of-care with results within minutes.
Real-time RT‑PCR diagnostic kits
Molecular diagnostic kits for laboratory RT‑PCR detection of SARS‑CoV‑2 RNA intended for CLIA-certified laboratories.
Rapid serology (IgM/IgG) lateral-flow kits
Rapid antibody tests that detect and differentiate IgM and IgG antibodies from small blood samples for assessment of prior exposure.
Ultra-sensitive malaria rapid diagnostic tests (uRDT)
Enhanced-sensitivity lateral-flow tests for Plasmodium falciparum detection designed for low-parasitemia and elimination research settings.
CareStart™
A molecular diagnostic test using real-time reverse transcription-polymerase chain reaction (RT-PCR) to detect RNA of the COVID-19 nucleocapsid gene and RNA-dependent RNA polymerase gene, providing results in 83 minutes with 100% sensitivity and specificity.
CareStart™ Dengue RDT
A qualitative rapid diagnostic test for dengue virus infection, designed to cover all clinical stages of dengue infection with detection of NS1 antigen and IgM/IgG antibodies.
Point-of-care antigen lateral-flow tests
Single-use lateral-flow assays for rapid detection of viral antigen at point-of-care with results within minutes.
Real-time RT‑PCR diagnostic kits
Molecular diagnostic kits for laboratory RT‑PCR detection of SARS‑CoV‑2 RNA intended for CLIA-certified laboratories.
Rapid serology (IgM/IgG) lateral-flow kits
Rapid antibody tests that detect and differentiate IgM and IgG antibodies from small blood samples for assessment of prior exposure.
Ultra-sensitive malaria rapid diagnostic tests (uRDT)
Enhanced-sensitivity lateral-flow tests for Plasmodium falciparum detection designed for low-parasitemia and elimination research settings.
CareStart™
A molecular diagnostic test using real-time reverse transcription-polymerase chain reaction (RT-PCR) to detect RNA of the COVID-19 nucleocapsid gene and RNA-dependent RNA polymerase gene, providing results in 83 minutes with 100% sensitivity and specificity.
CareStart™ Dengue RDT
A qualitative rapid diagnostic test for dengue virus infection, designed to cover all clinical stages of dengue infection with detection of NS1 antigen and IgM/IgG antibodies.
Services
On-site large-scale manufacturing of rapid diagnostic tests across multiple facilities for global distribution.
Collaborative research and development with partners to improve assay sensitivity and adapt tests for specific public‑health needs.
Support for regulatory submissions and national commercialization through distribution agreements.
On-site large-scale manufacturing of rapid diagnostic tests across multiple facilities for global distribution.
Collaborative research and development with partners to improve assay sensitivity and adapt tests for specific public‑health needs.
Support for regulatory submissions and national commercialization through distribution agreements.
Expertise Areas
- Rapid diagnostic test development
- Molecular diagnostics (real-time RT‑PCR)
- Serology assay development
- Assay validation and clinical performance evaluation
Key Technologies
- Lateral-flow immunoassays
- Real-time RT‑PCR
- Serological antibody detection
- Nucleic acid extraction and detection workflows
News & Updates
Large shipment of at-home COVID-19 test kits distributed to 19 school districts in Erie County for local distribution.
Collaboration with Global Good to release an ultra-sensitive malaria rapid diagnostic test with improved analytical sensitivity for low-parasitemia detection.
Agreements to expand national distribution and commercialization of COVID-19 diagnostic products via channel partners and distributors.
Announcement that a laboratory RT‑PCR SARS‑CoV‑2 test received Emergency Use Authorization enabling laboratory distribution and use.
Announcement that a rapid serology IgM/IgG test received FDA Emergency Use Authorization for detection of prior SARS‑CoV‑2 exposure.
Announcement that a point-of-care antigen test received FDA Emergency Use Authorization.
Large shipment of at-home COVID-19 test kits distributed to 19 school districts in Erie County for local distribution.
Collaboration with Global Good to release an ultra-sensitive malaria rapid diagnostic test with improved analytical sensitivity for low-parasitemia detection.
Agreements to expand national distribution and commercialization of COVID-19 diagnostic products via channel partners and distributors.
Announcement that a laboratory RT‑PCR SARS‑CoV‑2 test received Emergency Use Authorization enabling laboratory distribution and use.
Announcement that a rapid serology IgM/IgG test received FDA Emergency Use Authorization for detection of prior SARS‑CoV‑2 exposure.
Announcement that a point-of-care antigen test received FDA Emergency Use Authorization.