bioLytical Laboratories
bioLytical is a global leader in manufacturing rapid in vitro diagnostic tests focusing on infectious diseases. Their mission is to ensure access to fast, reliable, and effective testing solutions worldwide, empowering healthcare providers and patients to make informed health decisions. They develop innovative diagnostic tests for diseases such as HIV, hepatitis C, syphilis, and COVID-19, utilizing proprietary flow-through technology to deliver results in as little as one minute. With a strong commitment to quality, innovation, and social impact, bioLytical operates state-of-the-art manufacturing facilities in Canada and has a presence in over 70 countries, testing over 35 million people.
Industries
Nr. of Employees
medium (51-250)
bioLytical Laboratories
Richmond, Virginia, United States, North America
Products
INSTI HIV Self Test
Single-use, rapid flow-through immunoassay for detection of HIV-1 and HIV-2 antibodies using a fingerstick blood sample; visually read results in ~1 minute; specimen volume ~50 µL.
INSTI HIV-1/HIV-2 Antibody Test (POC)
Point-of-care rapid antibody test for HIV-1 and HIV-2 intended for clinical settings.
INSTI Multiplex Antibody Test
Rapid multiplex antibody test capable of detecting multiple serological targets (examples include HIV and syphilis) on a single platform.
INSTI HCV Antibody Test
Rapid antibody test for hepatitis C virus intended for clinical or screening use.
iStatis / iStatis COVID-19 Antigen Home Test
Lateral flow antigen test formatted for at-home use to detect SARS-CoV-2 antigens.
iStatis COVID-19 Antigen Test (POC)
Lateral flow antigen test intended for point-of-care use to detect SARS-CoV-2 antigens.
INSTI HIV Self Test
Single-use, rapid flow-through immunoassay for detection of HIV-1 and HIV-2 antibodies using a fingerstick blood sample; visually read results in ~1 minute; specimen volume ~50 µL.
INSTI HIV-1/HIV-2 Antibody Test (POC)
Point-of-care rapid antibody test for HIV-1 and HIV-2 intended for clinical settings.
INSTI Multiplex Antibody Test
Rapid multiplex antibody test capable of detecting multiple serological targets (examples include HIV and syphilis) on a single platform.
INSTI HCV Antibody Test
Rapid antibody test for hepatitis C virus intended for clinical or screening use.
iStatis / iStatis COVID-19 Antigen Home Test
Lateral flow antigen test formatted for at-home use to detect SARS-CoV-2 antigens.
iStatis COVID-19 Antigen Test (POC)
Lateral flow antigen test intended for point-of-care use to detect SARS-CoV-2 antigens.
Services
In-house R&D and assay development
End-to-end development of rapid immunoassays and diagnostic platforms performed by an internal R&D team.
ISO 13485 / MDSAP manufacturing and QC
Manufacture and quality-control release of in vitro diagnostic tests in a certified facility.
Regulatory affairs and market authorization support
Regulatory strategy and submission support for CE marking, Health Canada and other global approvals.
Commercial distribution and global logistics
Global sales, distribution and supply-chain operations servicing 60–70+ countries.
Technical support and training
Customer care, technical troubleshooting, training materials and instructional media for product use.
In-house R&D and assay development
End-to-end development of rapid immunoassays and diagnostic platforms performed by an internal R&D team.
ISO 13485 / MDSAP manufacturing and QC
Manufacture and quality-control release of in vitro diagnostic tests in a certified facility.
Regulatory affairs and market authorization support
Regulatory strategy and submission support for CE marking, Health Canada and other global approvals.
Commercial distribution and global logistics
Global sales, distribution and supply-chain operations servicing 60–70+ countries.
Technical support and training
Customer care, technical troubleshooting, training materials and instructional media for product use.
Expertise Areas
- Rapid infectious-disease diagnostics
- Point-of-care and at-home self-testing
- Immunoassay platform development (flow-through and lateral flow)
- Clinical performance validation and verification
Key Technologies
- Flow-through immunoassay
- Lateral flow immunoassay
- Fingerstick whole-blood testing
- Rapid antigen detection