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About Us
Microbix Biosystems Inc. develops and commercializes proprietary biological and technological solutions for human health and wellbeing.
We manufacture a wide range of critical biological materials for the global diagnostics industry, notably antigens used in immunoassays and Quality Assessment and Proficiency (QAPs™) testing products. Microbix’s business of producing high quality viral and bacterial preparations are the result of nearly over four decades of expertise in the field, including strain selection, reliable and efficient organism culture at scale, purification and methods of inactivation. As a result of Microbix’s expertise, its products have received widespread and longstanding customer acceptance, with continuing growth in demand. Microbix’s current catalogue of biological preparations covers a range of pathogens that are implicated in maternal, pediatric, childhood, respiratory, sexually-transmitted and insect-borne diseases. The company also applies its biological expertise to develop other innovative and proprietary technologies and products. Its development project pipeline currently includes Kinlytic® Urokinase, a biologic thrombolytic drug used to treat blood clots.
Core Values
Microbix’s employees are talented and caring professionals who are responsible for developing sophisticated science and technology applications, operating highly technical manufacturing processes and managing complex global business relationships. In all of our activities we adhere to the following guiding principles:
Putting People First
Whether business partners, patients or colleagues we are committed to effectively serving the needs of others in everything we do.
Commitment to Innovation
We must ‘think differently’ to ensure we remain strong and continue to grow and sustain our competitive edge.
Integrity and Ethics
We must ‘do the right thing’ and exercise care and good judgement in all of our activities.
Continuous Improvement
We must strive for a high standard of performance and be recognized for doing so by all of our stakeholders.
OUR HISTORY
1980s
Microbixʼs founder William J. Gastle develops the first product at his home in Ontario, Canada. The company was originally called Animal Health Laboratories Inc.
1984
William J. Gastle changes the name to Microbix Biosystems Inc.
1990s
Microbix occupies three sites in Toronto: 341 Bering Avenue, 109 Judge Road and 111 Judge Road.
1990
Microbix goes public on the Toronto Stock Exchange.
1995
Our Focus on Innovation
- Microbix uses the antigen business to financially support market opportunities.
- Microbix develops BioBlox, a new education product.
- Microbix develops ThromboClear™ , a biosimilar thrombolytic drug. In 2008, Microbix acquired the NDA of the original, approved version of this drug now known by the name Kinylytic®.
2000s
- Microbix develops and patents VirusMax, an influenza vaccine productivity innovation.
- Microbix partners with Genpharm (the Canadian generics division of Merck KGaA) to advance Thromboclear (the original product was Abbokinase made by Abbott Laboratories), eventually replaced by Kinlytic.
- Microbix develops and patents LumiSort (a cell sorting technology to separate X and Y chromosome bearing sperm cells for dairy and other industries).
2006
Microbix creates pandemic kits to help combat H1N1 influenza, commonly-known at the time as ʻbird fluʼ.
2008
Microbix starts supplying PT samples, an important step towards QAPs™. Microbix offers a range of products to proficiency organizations for use in their clinical laboratory certification programs.
2009
Microbix purchases 265 Watline Avenue and develops the site creating a state of the art, CL2+ facility to produce live pathogens. A formal opening ceremony was led by world-renowned Mayor of Mississauga, Hazel McCallion.
2012
Microbix appoints Vaughn Embro-Pantalony as the new CEO & President. Mr. Embro-Pantalony previously held senior executive positions in large biopharmaceutical and agriculture companies, including VP, Finance & CFO at Novopharm Limited, VP, Information Technology & CIO at Bayer Inc., VP, Finance & Administration at Bayer Healthcare, and General Manager of Terra International.
2015
Microbix signs its first Molecular Diagnostics Agreement with Microbiologics Inc. The partnership combines the company’s expertise in biomaterial development, preservation and distribution to create highly stable viral controls for molecular testing.
2016
Microbix confirms its production ramp-up, with a 500% increase in bioreactor capacity and other processing upgrades to improve the efficiency, capacity and reliability of its rubella products.
2017
Microbix appoints Meridian Life Science, Inc. (a wholly-owned company of Meridian Bioscience, Inc.) as exclusive distributor in Asia-Pacific. Meridian receives exclusive distribution rights to Microbix antigen products for China, Hong Kong, Taiwan and Macau.
2017
Cameron Groome is appointed the new CEO of Microbix. Before joining Microbix, he was the CEO of a company listed on the TSX Venture Exchange and EVP of a TSX-listed company, both in life sciences. Before his operational roles, he headed the healthcare activities of two national investment dealers. He has more than 25 years of experience as a leader, executive, equity analyst, investment banker, and corporate advisor. He has also been a member of the Life Sciences Advisory Group of Global Affairs Canada, and a director of public and private companies.
2018
Microbix launches its new Quality Assessment products (QAPs™), manufactured from native pathogens or synthetic whole genome of pathogens – to represent a very close facsimile of patient samples. Microbix adds the PROCEEDx™ line to its quality assessment offerings.
2018
Microbix wins the 2018 Business Innovation Award in recognition of innovations relating to manufacturing, development, and international commercialization of biological products for the diagnostics industry.
2019
Microbix expands its new Quality Assessment products (QAPs™). Microbix adds the REDx™ controls line to its portfolio, intended to evaluate laboratory testing performance, procedures, and workflow in nucleic acid and/or antigen-based assays that detect infectious disease pathogens in patient samples.
2019
In order to effectively support its QAPs ™ programs, Microbix announces a long term lease of an additional office, production, and warehousing space at 235 Watline Avenue in Mississauga. The newly-leased space further provides 10,300 square feet of space adjacent to its fully-owned 14,000 square foot production site at 265 Watline Avenue.
2020
Microbix and Copan Italia S.p.A. (Copan®), the global leader in specimen collection technologies, announce the execution of a agreement with Microbixʼs QAPs™ and Copanʼs flocked devices (FLOQ®). This combines Copanʼs well-known FLOQ® brand with Microbixʼs emerging PROCEEDx™ (RUO) and REDx™ (IVD) brands – to create REDx™FLOQ® and PROCEEDx™FLOQ® as worldwide branding for active co-marketing of leading-edge FLOQ®Swab-formatted QAPs™ by Microbix and Copan.
2020
William J. Gastle, Microbixʼs founder, and former CEO and Chairman of the Board, retires.
2020
Microbixʼs receives a grant of $1.45 million from the Ontario Together Fund to cover 50% of the cost to scale-up production of two emerging Microbix product lines – Viral Transport Medium (DxTM™), and Quality Assessment Products (QAPs™) to assist in managing the COVID-19 pandemic across Canada, Australia, the EU, Scandinavia, the UK, and the US.
2021
Microbix receives a $4.25 million order for its viral transport medium (generically known as “VTM” and branded as “DxTM™” by Microbix). DxTM is a test sample-collection device that is essential for PCR-testing for the virus causing COVID-19 disease.
2021
Microbix announces collaboration with SpeeDx Pty. Ltd (SpeeDx), under which Microbix will be exclusive developer of Quality Assessment Products (QAPs™) to facilitate the registration and commercialization of SpeeDx diagnostic assays.
2021
Microbix secures a third manufacturing site in Mississauga, Ontario, a long-term lease agreement for a property adjacent to its two current sites. This site is reconfigured and equipped to support additional business activities, including implementation of further scale-up, full automation of production processes for its DxTM™ branded viral transport medium (generically known as “VTM”), and commissioning of additional space for other fully-automated production processes, including QAPs™.
2022
Microbix launches their first podcast titled “Diagnostics: Beyond the Lab”, featuring industry leaders in the scientific and health community discussing discoveries, challenges, and the future of their fields. Collaborations included guests from Copan Italia, Becton Dickinson (BD), Cepheid, Labquality, Oneworld Accuracy, American Proficiency Institute (API), Newfoundland Memorial Hospital, Government of Ontario and SpeeDx.
2022
Microbix upgrades its mission-critical QMS and ERP systems to MasterControl® and NetSuite®, respectively. MasterControl has been a market leader for over 25 years, is active in over 50 countries and has a distinct Medtech focus – with over 750 client companies in that field. It’s ERP integrates seamlessly with MasterControl eQMS to provide Microbix with a complete and scalable digital solution.
2022
Microbix Executes a purchase and supply QAPs™ agreement for a multinational diagnostics developer, manufacturer, and marketer. The companyʼs portfolio of monoplex and multiplex QAPs™covered multiple disease categories and supported diagnostic assays on industry-leading molecular (PCR) and antigen-based POC (point-of-care) testing platforms.
2023
Microbix launched the quality assessment product (QAPs™) to support molecular diagnostic (MDx) testing for Monkeypox (Mpox). This Mpox QAP™ product underwent validation across 11 molecular diagnostic testing systems and multiple lab-developed tests at 33 clinical laboratories in Europe and Scandinavia.
2023
Microbix assists PEI (Prince Edward Island), the first Canadian province, to undertake full implementation of MDx HPV testing to improve cervical cancer screening from the pathology-based ‘Pap Tests’. The company presented the technical poster results of its collaboration with the Microbiology Laboratory of the Queen Elizabeth Hospital of Health PEI ( “Health PEI”), in support of provincial adoption of molecular diagnostic (“MDx”) screening for Human Papillomavirus ( “HPV”) infections.
2023
Microbix improved test accuracy for point-of-care testing (PoCT) of sexually transmitted infections (STIs) in remote Australian communities by supporting a program across 60 sites in five regions. These QAPs™ were validated for stability in high temperatures, addressing the unique challenges of remote locations and enhancing access to timely diagnosis and treatment for Chlamydia trachomatis, Neisseria gonorrhea, and Trichomonas vaginalis.
2023
Microbix supports a National-level HPV cervical-cancer Screening program in the Netherlands, with partner R-Biopharm. This program invited women aged 30 to 60 within the Dutch population of approximately 17.8 million.
2023
Due to doubled sales and an extensive product and service line, Microbix future-proofs business by implementing a new eQMS (MasterControl) and ERP (Netsuite) system to support and upgrade daily operations
2023
Microbix honored the enduring legacy of William J. (Bill) Gastle, Microbixʼs founder, for his significant contributions to the company and the life sciences industry. Bill led as CEO for 28 years and served as a director for 36 years, retiring in 2020. Under Billʼs vision and leadership, the company evolved into a global supplier of essential components for infectious disease testing and a diverse range of diagnostic support products. His commitment to innovation and excellence continues to shape Microbixʼs path forward.
2023
Microbix demonstrated it’s commitment to public health by supporting diagnostic solutions to global cancer prevention through partnerships supplying QAPs™ for HPV MDx testing within Irelandʼs national cervical cancer screening program. The company expanded its international reach with the provision of REDx® liquid-format IVD-regulated multiplex QAPs™, essential for quality management system monitoring and test accuracy.
2023
Microbix reconfirmed a fully-funded partnership with Sequel Pharma, LLC to reintroduce Kinlytic® urokinase for catheter clearance in the U.S., reinforcing the commitment to making this important biologic drug available again. The company recieved an additional US$ 2.0 million payment following positive FDA consultation, marking progress toward regulatory submission and future market re-entry.
2023
Microbix partnered with BioGX Inc. to become the primary provider of external quality controls for their new real-time PCR platform called pixl™, enhancing the accuracy and reliability of a wide variety of infectious organisms. This collaboration strengthened the delivery of effective, extraction-free PCR testing solutions for detecting pathogens like SARS-CoV-2, Influenza, and Group A Strep.
2023
Microbix and Seegene USA join forces to improve lab test accuracy through Quality Assessment Products (QAPs™) for infectious diseases.
2024
Microbix achieved significant recognition at a prominent Helsinki conference by presenting the innovative H.pylori External Quality Control (QAP™), designed to enhance the clinical accuracy of molecular diagnostic (MDx) tests for Helicobacter pylori, the bacterium linked to stomach ulcers. A pilot external quality assessment (EQA) program validated its performance across 13 laboratories utilizing seven different assays and platforms, setting a new benchmark for diagnostic quality.
2024
Microbix pushed the return of Kinlytic® urokinase, a clot-dissolving biologic, to clinical use by supporting Sequel Pharma in securing an agreement with a top international CDMO for drug substance production. This pivotal step set the groundwork for reintroducing Kinlytic to the US$ 350 million U.S. market for catheter clearance.
2024
Microbix has enhanced its manufacturing by using bioreactor technology to produce a second high-demand bacterial antigen. This advancement enables higher yields, greater efficiency, and reduced lab space usage. By applying bioreactors to both bacterial and viral antigens, Microbix increases flexibility and responsiveness to evolving customer needs.
2024
Microbix expanded global market access by achieving EU IVDR certification and CE marking for 11 REDx ™ QAPs™, meeting strict regulatory standards. This milestone validates its quality systems and reinforces its commitment to providing trusted, IVDR-compliant tools for clinical labs.
2024
Microbix partnered with the European Molecular Genetics Quality Network (EMQN) to support a new EQA program for genetic testing. By supplying REDx™ Controls that mimic real patient samples, Microbix helped labs validate and monitor test performance, improving accuracy and reliability in MDx.
2025
Microbix adopted a strategic partnership model with diagnostic test developers, integrating its QAPs™ (REDx™, PROCEEDx ™) and recombinant antigens into early assay development. This approach enhanced test quality, supported regulatory compliance, and expanded global access to Microbixʼs trusted quality controls.
2025
Microbix partnered with the Association of Public Health Laboratoriesʼ API division to enhance flu test accuracy amid the emerging H5N1 avian influenza in North America. They helped diagnostic labs verify their testsʼ ability to detect this strain using Microbix’s external quality controls, boosting public health readiness through better test performance and early detection.
2025
Microbix partnered with the Australian Centre for the Prevention of Cervical Cancer (ACPCC) to help eliminate cervical cancer in the Indo-Pacific, where it remains a leading cause of female death. Microbix supplied PROCEEDx™FLOQ® (RUO) and REDx™FLOQ® (IVD) QAPs™, which mimic patient samples to ensure accurate HPV molecular testing.
2025
Microbix Biosystems Inc. has advanced its Kinlytic® urokinase project, a biologic drug used to dissolve blood clots—by partnering with Sequel Pharma, LLC and securing a leading CDMO to produce the finished drug product. The initiative aims to reintroduce Kinlytic® to the U.S. market, focusing on treating catheter-related blood clots, a $400 million sector.
2025
Microbix Biosystems Inc. partnered with UK-based Aurevia to launch a new EQA scheme for molecular diagnostics. The program uses Microbixʼs non-infectious, patient-like QAPs™ to help labs verify test accuracy, enhance quality assurance, and meet regulatory standards. By combining Aureviaʼs digital platform with Microbixʼs controls, the partnership aims to elevate diagnostic testing standards and improve patient outcomes worldwide.
2025
Microbix partnered with Bulgariaʼs National Center for Infectious and Parasitic Diseases (NCIPD) in a multi-year agreement to develop new Quality Assessment Products (QAPs™) using NCIPDʼs pathogen seedstocks. This collaboration will expand Microbixʼs portfolio of around 300 QAPs, improving diagnostic accuracy worldwide.
2025
Microbix launches QUANTDx™, a new product line of well-characterized reference materials designed to support the development and validation of diagnostic assay.
2025
Microbix Biosystems Inc. partnered with EMQN, a global supplier of laboratory external quality assessment (“EQA”) schemes for human genomic testing. The program supported rapid and accurate identification of patients who carry gene-variants associated with faster and slower than normal metabolism of the widely-prescribed antiplatelet (anti-clotting) drug Clopidogrel (brand named Plavix®).
2025
Microbix Biosystems Inc. partnered with SEKISUI Diagnostics, LLC to support their U.S. commercialization of the molecular point-of-care assay for diagnosis of COVID/Flu A/Flu B using the Metrix® platform from Aptitude Medical Systems, Inc. (Aptitude) with kits of its REDx™FLOQ® QAPs®.
