BioLytical Laboratories
Manufacturer of rapid point-of-care in vitro diagnostic tests focused on infectious diseases. Develops assay platforms in-house, operates an ISO/MDSAP-certified manufacturing facility in Richmond, British Columbia, and distributes diagnostic tests globally for antibody and antigen detection with emphasis on short run-times and low sample volumes.
Industries
Nr. of Employees
medium (51-250)
BioLytical Laboratories
Patents
Products
INSTI HIV Self Test
Rapid antibody test for personal use designed to provide a visual result in approximately one minute from capillary blood.
INSTI HIV-1/2 Antibody Test (professional)
Professional rapid antibody test for HIV-1 and HIV-2 that provides results in approximately one minute.
Multiplex HIV-1/2 and Syphilis Antibody Test
Rapid multiplex antibody test intended to detect HIV-1/2 and syphilis markers from a single specimen.
Hepatitis C Antibody Test (professional)
Rapid antibody test for hepatitis C intended for professional use with short run-time.
iStatis Hepatitis B Surface Antigen Test
Lateral-flow antigen test for hepatitis B surface antigen intended for professional use with ~15 minute run-time.
iStatis Syphilis Antibody Test
Lateral-flow antibody test for syphilis intended for professional use (≈15 minute run-time).
INSTI HIV Self Test
Rapid antibody test for personal use designed to provide a visual result in approximately one minute from capillary blood.
INSTI HIV-1/2 Antibody Test (professional)
Professional rapid antibody test for HIV-1 and HIV-2 that provides results in approximately one minute.
Multiplex HIV-1/2 and Syphilis Antibody Test
Rapid multiplex antibody test intended to detect HIV-1/2 and syphilis markers from a single specimen.
Hepatitis C Antibody Test (professional)
Rapid antibody test for hepatitis C intended for professional use with short run-time.
iStatis Hepatitis B Surface Antigen Test
Lateral-flow antigen test for hepatitis B surface antigen intended for professional use with ~15 minute run-time.
iStatis Syphilis Antibody Test
Lateral-flow antibody test for syphilis intended for professional use (≈15 minute run-time).
Services
Global sales and distribution of rapid infectious-disease diagnostic test kits for professional and self-use.
Regulatory strategy and quality management experience to support product approvals and ongoing compliance.
Global sales and distribution of rapid infectious-disease diagnostic test kits for professional and self-use.
Regulatory strategy and quality management experience to support product approvals and ongoing compliance.
Expertise Areas
- Point-of-care diagnostic development
- Immunoassay (antibody and antigen) design
- In-vitro diagnostic manufacturing (ISO/MDSAP)
- Clinical evaluation and performance validation
Key Technologies
- Flow-through immunoassay technology
- Lateral-flow immunoassays
- Point-of-care diagnostics
- Multiplex antibody/antigen assays
News & Updates
Company donation of 4,200 rapid HIV self-tests for National HIV Testing Day activities at a retail partner in the USA.
Announcement regarding authorization of a rapid point-of-care hepatitis B test in North America.
Participation of the HIV self-test in a national free distribution program delivering self-tests across the United States.
Products sold in 70 countries and over 35 million people tested using company tests.
Referenced authorization for a rapid hepatitis B test by Health Canada.
Company donation of 4,200 rapid HIV self-tests for National HIV Testing Day activities at a retail partner in the USA.
Announcement regarding authorization of a rapid point-of-care hepatitis B test in North America.
Participation of the HIV self-test in a national free distribution program delivering self-tests across the United States.
Products sold in 70 countries and over 35 million people tested using company tests.
Referenced authorization for a rapid hepatitis B test by Health Canada.