BioLytical Laboratories
BioLytical Laboratories is a Canadian rapid diagnostics company that develops and manufactures one-minute INSTI and 15-minute iStatis point-of-care tests for HIV, HCV, syphilis, hepatitis B, and COVID-19, distributed in over 70 countries via channel partners, pharmacies, and public health programs.
- Company typePrivate
- Founded2005
- HeadquartersRichmond, United States
- Headcount101–250
- GTM typeB2B and B2C
- OfferingHardware or Manufacturing
What BioLytical Laboratories does
BioLytical Laboratories Inc. is a privately held Canadian biotechnology company headquartered in Richmond, British Columbia, with a U.S. operating office in Ferndale, Washington. Founded in 2005, the company develops and manufactures rapid point-of-care diagnostic tests built around a proprietary flow-through immunoassay platform that delivers results in as little as one minute. Its product portfolio is organized under two sub-brands: INSTI (one-minute tests for HIV self-test, HIV-1/2 antibody, multiplex HIV/Syphilis, and HCV antibody) and iStatis (15-minute tests for COVID-19 antigen, syphilis antibody, and hepatitis B surface antigen).
The company derives revenue primarily through the sale of hardware diagnostic kits to a diversified mix of channel partners, including regional and international distributors, pharmacy networks, group purchasing organizations such as Vizient, and government/NGO-led public health programs including Together TakeMeHome and Coalition Plus. Pricing is not publicly disclosed and is negotiated through dedicated account managers. BioLytical has secured multi-jurisdictional regulatory approvals (FDA, Health Canada, WHO Prequalification, CE Mark, Australian ARTG) and distributes in 70+ countries, with more than 35 million people tested cumulatively using its products.
BioLytical's go-to-market combines channel-partner distribution with event-driven demand generation at major healthcare conferences (Medica, Arab Health, USCHA, IAS, EACS) and a direct-to-consumer motion for the INSTI HIV Self Test via pharmacies and U.S. public health programs. Its competitive position rests on test speed (the world's fastest HIV test), integrated control features, room-temperature stability eliminating cold chain requirements, and a regulatory footprint spanning 70+ jurisdictions.
BioLytical Laboratories firmographics
Firmographics- Name
- BioLytical Laboratories
- Legal name
- bioLytical Laboratories Inc.
- Website
- https://biolytical.com
- Company type
- Private
- Founded year
- 2005
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- BioLytical Laboratories is a Canadian rapid diagnostics company that develops and manufactures one-minute INSTI and 15-minute iStatis point-of-care tests for HIV, HCV, syphilis, hepatitis B, and COVID-19, distributed in over 70 countries via channel partners, pharmacies, and public health programs.
- Ownership category
- akta.pro rank
BioLytical Laboratories industry classification
Industry- Product category
- In-Vitro Rapid Diagnostics
- NAICS
- Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Clinical Chemistry & Immunoassay Laboratories (HLAFAMAB)
- akta.pro secondary industry
- Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)
Keywords
Where BioLytical Laboratories is headquartered
LocationHeadquarters
- HQ city
- Richmond
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
BioLytical Laboratories business model
Business model- GTM type
- B2B and B2C
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Supply Chain, Operations, Marketing or Sales, Infrastructure
Revenue model
- Rapid Diagnostic Test Kits: Sale of INSTI and iStatis rapid test products for HIV, HCV, Syphilis, COVID-19, and Hepatitis B. Products are sold to healthcare providers, distributors, pharmacies, and directly to consumers. Manufacturing with short lead times and fast shipping.
Go-to-market motion3 records
Distribution channels4 records
Marketing channels6 records
BioLytical Laboratories product offering
Product offeringCore offering
BioLytical Laboratories develops and manufactures rapid point-of-care diagnostic test kits under the INSTI (1-minute tests) and iStatis (15-minute tests) brands for HIV, HCV, Syphilis, COVID-19, and Hepatitis B. The company sells both professional-use tests to healthcare providers and self-tests directly to consumers, using proprietary flow-through immunoassay technology that delivers results without timing devices, refrigeration, or specialized equipment. Products are distributed globally across 70+ countries through distributor networks, pharmacy chains, and group purchasing organizations.
Product overview
BioLytical Laboratories offers a portfolio of rapid point-of-care diagnostic tests organized under two sub-brands: INSTI (1-minute tests) and iStatis (15-minute tests). The INSTI line includes HIV self-test, HIV-1/2 antibody test, multiplex HIV/syphilis test, and HCV antibody test. The iStatis line includes COVID-19 antigen tests (home and professional), syphilis antibody test, and hepatitis B surface antigen test. The company utilizes proprietary flow-through immunoassay technology that enables near-instant results without the need for timing devices, refrigeration, or complex procedures. Tests are designed for both self-use (consumer) and professional point-of-care settings, supporting disease screening in over 70 countries.
Differentiator
Problem solved
Functional benefit
Brands
- INSTI: Premium rapid test brand featuring the world's fastest HIV test with results in 1 minute, includes HIV Self Test, HIV-1 HIV-2 Antibody Test, Multiplex HIV-1/2 Syphilis Test, and HCV Antibody Test.
- iStatis
Products and services
- INSTI HIV Self Test A rapid, single-use, visual-read self-test that detects antibodies against HIV type 1 and type 2 using a drop of blood from a finger prick. Provides results in 60 seconds with 99.8% sensitivity and 99.5% specificity. Designed for personal at-home use by individual consumers.
- INSTI HIV-1 HIV-2 Antibody Test A rapid, single-use, visual-read flow-through immunoassay for professional use that detects antibodies against HIV-1 and HIV-2 using capillary whole blood, venous whole blood, serum, or plasma samples. Delivers results in 1 minute and is used by healthcare professionals in clinical settings.
- INSTI Multiplex HIV-1/2 Syphilis Antibody Test A rapid multiplex test that detects antibodies to both HIV-1/2 and syphilis from a single sample, providing two results in one minute. Designed for point-of-care professional use in clinical settings.
- INSTI HCV Antibody Test The world's first CE-marked 1-minute hepatitis C antibody rapid test, enabling detection of HCV antibodies to help eliminate HCV as a public health problem. For professional use.
- iStatis COVID-19 Antigen Home Test A rapid antigen home test for detecting active COVID-19 infection, providing results in 15 minutes. Received WHO Prequalification for global market access and is designed for personal use at home.
- iStatis COVID-19 Antigen Test A professional-use rapid antigen test for detecting active COVID-19 infection, delivering results in 15 minutes. Authorized by Health Canada for identifying active infections in clinical settings.
- iStatis Syphilis Antibody Test A rapid point-of-care test for detecting syphilis antibodies, providing results in under 15 minutes. Included in the Australian Register of Therapeutic Goods (ARTG) for distribution in Australia. For professional use.
- iStatis Hepatitis B Surface Antigen Test North America's first Health Canada-authorized rapid point-of-care test for hepatitis B, providing results in 15 minutes. Designed to improve access to hepatitis B screening and early diagnosis. For professional use.
Quantifiable outcome
- >99% sensitivity (Positive Percent Agreement) and >99% specificity (Negative Percent Agreement) for INSTI HIV tests
- +3 more outcomes
Companies that use BioLytical Laboratories
Customer profileNamed customers5 records
Segments4 records
Ideal customer profiles4 records
BioLytical Laboratories technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
BioLytical Laboratories partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core, minor and regional.
- WalgreenscoreWalgreens serves as a distribution partner for bioLytical's INSTI HIV Self Tests. bioLytical donated 4,200 INSTI HIV Self Tests for National HIV Testing Day activities at Walgreens locations across the USA, marking the company's first donation of self-tests within the US market.
- Together TakeMeHomecorePartnership to support Together TakeMeHome's national program delivering free HIV self-tests directly to individuals across the United States. bioLytical's INSTI HIV Self Test is included in this free testing initiative.
- VizientcoreVizient awarded an innovative technology contract to bioLytical for the INSTI rapid HIV test. This contract enables healthcare facilities within the Vizient network to access INSTI testing products.
- Coalition PlusminorPartnership with international NGO Coalition Plus to donate HIV tests supporting International Testing Week initiatives aimed at increasing global testing access.
- Kenya Pharmacy NetworksregionalINSTI HIV Self Test launched through Kenya's regulated pharmacy network, enabling wider access to HIV self-testing across Kenya.
- WHO-UNITAIDcoreActive participation in WHO-UNITAID Manufacturers events to support global access to affordable diagnostic testing.
Scale indicators4 records
Recent moves6 records
Expansion highlights6 records
BioLytical Laboratories competitors and assessment
Company assessmentDirect peers
- OraSure Technologies: OraSure is the most direct peer, selling the OraQuick HIV self-test and other rapid infectious disease diagnostics with similar point-of-care positioning, OTC approvals, and global health distribution — directly competing with INSTI on HIV self-testing.
- Chembio Diagnostics: Chembio develops rapid point-of-care immunoassay tests for HIV, syphilis, and febrile illness with comparable technology, regulatory pathway (FDA, WHO Prequalification), and target customer base of NGOs and public health programs.
- SD Biosensor: SD Biosensor is a Korean rapid diagnostics maker with HIV, COVID, and infectious disease lateral-flow products sold globally, including strong presence in emerging markets and WHO Prequalified assays — directly competing with both INSTI and iStatis.
- Trinity Biotech: Trinity Biotech manufactures diagnostic tests for HIV, hepatitis, and other infectious diseases sold through clinical labs and point-of-care channels, overlapping BioLytical's HIV/STI portfolio and global distribution model.
Broad incumbents
- Abbott Diagnostics (Alere): Abbott is a global diagnostics incumbent whose rapid test portfolio (BinaxNOW, Determine, m-PIMA) competes across HIV, hepatitis, and infectious disease markets with much greater scale, distribution reach, and hospital contracts than BioLytical.
- bioMérieux: bioMérieux is a major in vitro diagnostics company serving clinical and industrial microbiology markets, providing broader diagnostic instrument and reagent portfolios that overlap BioLytical's infectious disease focus at a much larger scale.
- QuidelOrtho: QuidelOrtho develops rapid immunoassay and molecular diagnostic products (Sofia, Triage) sold to hospitals, physician offices, and retail — overlapping BioLytical's rapid-test positioning in infectious disease screening with greater commercial scale.
- Hologic: Hologic's diagnostics division sells HIV, STI, and women's health assays including the Aptima and Panther molecular platforms — overlapping BioLytical's HIV/STI focus from a higher-accuracy, centralized-lab angle while competing for the same clinical budgets.
- Cepheid (Danaher): Cepheid's GeneXpert system delivers molecular HIV, HCV, and HBV viral load testing in decentralized settings — competing for global health and public health program budgets that also purchase BioLytical's rapid antibody tests.
Emerging players
- Atomo Diagnostics: Atomo is an Australian rapid diagnostics company focused on integrated HIV and HCV self-test devices — a smaller emerging peer with overlapping point-of-care HIV testing technology and emerging-market distribution ambitions.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat3 records
Key risks5 records
Key highlights7 records
Customer concentration
BioLytical Laboratories social profiles
Digital presenceBioLytical Laboratories compliance and trust
Trust signalCompliance6 records
BioLytical Laboratories financial estimates
Financial estimateRevenue estimate
Valuation estimate
BioLytical Laboratories leadership team
Management profileNumber of profiles
Profiles4 records
BioLytical Laboratories funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
BioLytical Laboratories M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about BioLytical Laboratories
What does BioLytical Laboratories do?
BioLytical Laboratories develops and manufactures rapid point-of-care diagnostic test kits under the INSTI (1-minute tests) and iStatis (15-minute tests) brands for HIV, HCV, Syphilis, COVID-19, and Hepatitis B. The company sells both professional-use tests to healthcare providers and self-tests directly to consumers, using proprietary flow-through immunoassay technology that delivers results without timing devices, refrigeration, or specialized equipment. Products are distributed globally across 70+ countries through distributor networks, pharmacy chains, and group purchasing organizations.
Is BioLytical Laboratories a public or private company?
BioLytical Laboratories is a private company. It is classified as management employee owned and is currently operating.
When was BioLytical Laboratories founded?
BioLytical Laboratories was founded in 2005. It employs 101 to 250 people.
Where is BioLytical Laboratories based?
BioLytical Laboratories is headquartered in Richmond, United States, in the North America region.
How does BioLytical Laboratories make money?
One revenue line is on record: rapid Diagnostic Test Kits.
Who are BioLytical Laboratories's main competitors?
Direct peers on record are OraSure Technologies, Chembio Diagnostics, SD Biosensor and Trinity Biotech. Broad incumbents are Abbott Diagnostics (Alere), bioMérieux, QuidelOrtho, Hologic and Cepheid (Danaher). Atomo Diagnostics is listed as an emerging player.
Does BioLytical Laboratories have an API?
No public API is recorded for BioLytical Laboratories.
What industry is BioLytical Laboratories in?
BioLytical Laboratories's product category is In-Vitro Rapid Diagnostics. Its primary akta.pro industry code is HLAFAMAB, Clinical Chemistry & Immunoassay Laboratories, with a secondary code of HLAGAIAI, Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes). Its NAICS code is 621511 and its SIC code is 8071.