Ankündigung • May 07
Microbix Biosystems Inc. to Report Q2, 2026 Results on May 14, 2026 Microbix Biosystems Inc. announced that they will report Q2, 2026 results Pre-Market on May 14, 2026 Ankündigung • Feb 05
Microbix Biosystems Inc. to Report Q1, 2026 Results on Feb 12, 2026 Microbix Biosystems Inc. announced that they will report Q1, 2026 results Pre-Market on Feb 12, 2026 Ankündigung • Jan 14
Microbix Biosystems Inc., Annual General Meeting, Mar 25, 2026 Microbix Biosystems Inc., Annual General Meeting, Mar 25, 2026. Ankündigung • Jan 07
Microbix Commercializes Sars-Cov-2 (Covid) Recombinant Antigen for Usage in Qaps and Test Manufacturing Microbix Biosystems Inc. announced the commercial usage of its first recombinant antigen product, the nucleocapsid protein of the SARS-CoV-2 virus (COVID-19), in its quality assessment products ("QAPs™?") and its availability at commercial scale for test manufacturers. This is the first commercial product to emerge from the development program announced in January 2025, whereby Microbix committed to extend its capabilities into recombinant (i.e., synthetic) antigen production to complement its longstanding expertise in native antigen production. This internally-made recombinant antigen has been developed, manufactured at commercial scale, and fully validated. Accordingly, it is now being used in Microbix's QAPs to support clinical laboratory proficiency testing or external quality assessment programs ("PT" or "EQA"), and is being incorporated into PROCEEDx®? (RUO) and REDx®? (IVD) branded QAPs used to support ongoing quality management of clinical laboratories or other testing sites. Microbix has 40 years of expertise in the technically-challenging manufacturing of native viral antigens, which requires culturing of mammalian host cells, the addition and growth of target viruses in those cells, and, finally, the extraction, purification, and inactivation of high-quality components for infectious-disease tests in commercial quantities. Ankündigung • Dec 12
Microbix Biosystems Inc. to Report Q4, 2025 Results on Dec 18, 2025 Microbix Biosystems Inc. announced that they will report Q4, 2025 results Pre-Market on Dec 18, 2025 Ankündigung • Dec 11
Microbix Biosystems Inc. Launches New Products to Support H3N2 Flu Testing Microbix Biosystems Inc. announced the commercial launch of QAPs™? quality assessment products and availability of QUANTDx™? reference materials to support antigen or molecular tests for H3N2 strains of seasonal Influenza A (a.k.a., the "Flu"). H3N2, alongside H1N1, is a common type of Influenza A that circulates annually, with H3N2 more prone to "antigenic drift," changing the surface of the virus and its level of recognition by antibodies. These changes can reduce the level of protection natural immunity and vaccine-induced immunity normally provide. Specifically, Microbix's Respiratory QAPs formulated with H3N2 can be used as safe, reliable, and stable molecularetics of patient-samples for training of persons administering tests, validation of new testing sites, and verification of instrument/assay performance. Depending on the nature of their needs, users can select either PROCEEDx®? (RUO) or REDx®? (IVD) variants of these QAPs. Upon request, H3N2 reference materials can also be made available, as part of Microbix's QUANTDx product-line. QUANTDx products are well-characterized, accurately-quantified and fully-traceable reference materials that enable assay developers to establish key analytical performance metrics - such as LoD (limit of detection), Sens sensitivity (positive accuracy), and Specificity (negative accuracy) - knowledge that is essential for validation and regulatory submissions. Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably Kinlytic®? urokinase, a biologic thrombolytic drug used to treat blood clots, and agents to support diagnostic testing (e.g., its DxTM™? for patient-sample collection). Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada. Ankündigung • Aug 07
Microbix Biosystems Inc. to Report Q3, 2025 Results on Aug 14, 2025 Microbix Biosystems Inc. announced that they will report Q3, 2025 results Pre-Market on Aug 14, 2025 Ankündigung • May 08
Microbix Biosystems Inc. to Report Q2, 2025 Results on May 15, 2025 Microbix Biosystems Inc. announced that they will report Q2, 2025 results Pre-Market on May 15, 2025 Ankündigung • Feb 06
Microbix Biosystems Inc. to Report Q1, 2025 Results on Feb 13, 2025 Microbix Biosystems Inc. announced that they will report Q1, 2025 results After-Market on Feb 13, 2025 Ankündigung • Jan 15
Microbix Biosystems Inc., Annual General Meeting, Mar 26, 2025 Microbix Biosystems Inc., Annual General Meeting, Mar 26, 2025. Ankündigung • Jan 14
Microbix Biosystems Inc. and American Proficiency Institute Announce the Start of Pilot Pt Program to Ensure That Molecular Diagnostic Assays Microbix Biosystems Inc. and American Proficiency Institute announced the start of a pilot PT program to ensure that molecular diagnostic assays can detect the emerging H5N1 strain of the Influenza A virus (“H5N1 Flu”). Strains of the Flu are named according to variations in the proteins that help them to infect host cells – the Hemagglutinin protein and the Neuraminidase protein. There is a heightened risk of a pandemic when one or both of the H or N proteins have not been circulating in human populations. H5N1 is such a relatively novel strain of the Flu virus, which has demonstrated the ability to infect birds, cattle, and humans. H5N1 Flu is now circulating on multiple continents and may become a new pandemic, with it having demonstrated a staggering rate of severe pneumonia and death across those infected thus far. It is therefore critical to prove whether established MDx tests can accurately and reliably detect H5N1 Flu. Such MDx Flu tests include both regulator-approved assays and laboratory-developed tests, respectively classed as “IVD” and “LDT”. Clinical labs must objectively prove that every such assay they are using can reliably detect H5N1 Flu requiring novel quality assessment products and new PT programs. Microbix and API have been collaborating to fulfill this critical and urgent need. Using its virology and synthetic biology expertise, Microbix has created a novel QAP that provides the whole genome of H5N1 Flu, but which does not require use of nor contain any infectious materials. In turn, API is initiating a proficiency testing program whereby clinical labs can independently confirm their MDx assays and the established workflows in use will reliably detect H5N1 Flu. This pilot PT program is now live, and API will invite a limited number of labs to participate before such a program is offered to all API clients. Ankündigung • Jan 08
Microbix Biosystems Inc. Announces its Intentions to Broaden its Platform Capabilities to Enable Production of Wide Range of Test Ingredients (Antigens) by Using Recombinant Production Technologies Microbix Biosystems Inc. announced its intentions to broaden its platform capabilities to enable production of a wide range of test ingredients (Antigens) by using recombinant production technologies. Directing existing in-house synthetic biology capabilities to this project will create large-scale recombinant Antigens production to complement and expand Microbix’s addressable market share as a key supplier to manufacturers of immunoassays – the class of diagnostic tests that establishes exposure to, or immunity from, pathogens. Microbix has been a leading producer of purified and inactivated Antigens from native (natural) bacterial and viral organisms for more than three decades. It supplies these critical biological ingredients to more than 100 international manufacturers of immunoassays where test accuracy is maximized by using such Antigens. Microbix’s sales of native Antigens totaled CAD 13.8 million in fiscal 2024, an increase of 44% from the prior year and generated from a catalogue of dozens of these complex and valuable biomaterials. However, to date Microbix has not broadly participated in making Antigens using the recombination of genetic materials from different species (i.e., recombinant technologies). Such recombinant Antigens can have price advantages relative to native Antigens and are the choice of immunoassay makers in situations where they can be used without sacrificing assay performance. Microbix offering recombinant Antigens will increase the extent to which it can grow sales of this important segment of its business. Microbix has therefore decided to fund the augmentation of its internal capabilities in synthetic biology in order to build the processes and capacity for production of recombinant Antigens. This will entail adding trained staff, equipment, biological vectors, and cell-lines. With the infrastructure and capabilities already built-out over the past several years, the incremental investment needed to drive the opening of these new market opportunities will be modest, at about CAD 0.5 million per year. Ankündigung • Dec 19
Microbix Biosystems Inc. Provides Financial Guidance for the Full-Year of Fiscal 2025 Microbix Biosystems Inc. provides financial guidance for the full-year of fiscal 2025. For the period, the company will continue driving sales growth across all of its business lines, while working to keep improving percentage gross margins, and delivering bottom-line results. The company currently expects to generate meaningful year-over-year growth in revenues. Ankündigung • Dec 12
Microbix Biosystems Inc. to Report Q4, 2024 Results on Dec 19, 2024 Microbix Biosystems Inc. announced that they will report Q4, 2024 results Pre-Market on Dec 19, 2024 Ankündigung • Nov 12
KOL Collaborators Present Microbix HPV Test-Control Results Microbix Biosystems Inc. announced that key opinion leader collaborators are presenting results of a Microbix Quality Assessment Product (“QAP”) for controlling testing for high-risk types of Human Papilloma Virus at the 36th annual International Papillomavirus Conference (“IPVC”) taking place in Edinburgh, Scotland, November 12 to 15, 2024. IPVC is the annual conference of the International Papillomavirus Society (“IVPS”), a not-for-profit organization of biomedical scientists investigating human and animal papillomaviruses and their associated diseases. IPVS is the global authority on papillomaviruses and its mission is to contribute to the elimination of papillomavirus-related diseases. HPV is best known as the undisputed cause of cervical cancer in women, driven by long-term infection with one or more high-risk types of the virus family. When properly validated and controlled, molecular (e.g., PCR-based) testing for HPV infection enables cervical cancer screening programs to identify at-risk patients years before the development of invasive cancer. Furthermore, cervical cancer screening programs can increase participation rates by enabling women to “self-collect” samples in the privacy of their homes, rather than remaining reliant on whether every at-risk women has ready access to medical professionals to collect their samples. At IPVC, authors Willem Ford, Marco Ho Ting Keung, and David Hawkes will present their poster titled “Validation of Commercial FLOQSwab® Quality Control for Human papillomavirus detection on six ISO 15189 accredited self-collection methods.” Their aim was to examine the compatibility of Microbix’s PROCEEDx®FLOQ® (HPV 16/18/45) QAP (RUO) to support testing for the three most common high-risk types of HPV and assess its viability as a quality control (“QC”) product. Their work tested use of this Microbix QAP with two commonly-used liquid media and six commercial and clinically-validated HPV assays. The results indicate that this QAP could be used for effective estimation of sensitivity, specificity, and both negative and positive predictive values with different self-collection methods and has a 100% concordance with detection across the two media types and for all six HPV assays. The authors concluded that the PROCEEDxFLOQ (HPV 16/18/45) “has excellent analytical performance and provides a QC product for use by laboratories processing self-collection using methods involving the Copan FLOQSwab''. Microbix thanks Professor David Hawkes, the Australian Centre for the Prevention of Cervical Cancer, the University of Melbourne (Australia), and the University of Malaya (Malaysia) for conducting this work. Ankündigung • Oct 07
Microbix Biosystems Inc. to Present Results of Novel Quality Assessment Product At the European Meeting on Molecular Diagnostics Microbix Biosystems Inc. announced that it is presenting results of a novel Quality Assessment Product ("QAPTM") for supporting patient diagnosis and tissue analysis relating to infection with the Herpes Simplex Virus ("HSV") at the European Meeting on Molecular Diagnostics ("EMMD") taking place in Noordwijk, The Netherlands, October 9 to 11, 2024. At EMMD, Microbix will interact with key opinion leaders, collaborators, and customers that create and utilize the available assays to diagnose, screen, and direct treatment of HSV, many other infectious diseases, and other conditions such as cancers. Microbix will also be attending multiple scientific and clinical care lectures and discussions that are directly pertinent to its ever-growing portfolio of QAPs that help ensure the accuracy of molecular (i.e., "PCR") tests and their workflows. Also at EMMD, Microbix will present its poster titled "FFPE HSV-1 and HSV-2 simulated tissue sections mounted on slides for use as prospective quality controls in IHC and qPCR workflows." The poster reviews the performance of a novel (RUO) QAP to support PCR-based detection of HSV and immunohistochemical analysis of Formalin-Fixed and Paraffin-Embedded ("FFPE") tissue samples. Following presentation of the poster on the afternoon of October 9th, it will be made available at https://microbix.com. In spite of efforts to detect, treat, and prevent the spread of HSV, it is estimated that over half of all people worldwide are chronically infected with a strain of this virus. Emerging research is also establishing that chronic infection with HSV is a risk factor for, and can lead to, severe conditions like esophagitis, hepatitis, pneumonia, encephalitis, cancer, and neurodegenerative disorders. More widespread diagnosis of HSV and detailed analysis of infected tissues may therefore be a route to prevention of the serious health consequences that can result from HSV infections. Microbix is pleased to support the more widespread use of such testing by helping to ensure its quality and accuracy. Ankündigung • Aug 07
Microbix Biosystems Inc. to Report Q3, 2024 Results on Aug 13, 2024 Microbix Biosystems Inc. announced that they will report Q3, 2024 results Pre-Market on Aug 13, 2024 Ankündigung • Jul 26
Microbix Biosystems Inc. Presents HCV FLOQSwab Format Test Control at ADLM Microbix Biosystems Inc. announced that it is presenting results of a novel Quality Assessment Product for supporting Point-of-Care-Tests for infection with the Hepatitis C Virus at the American Diagnostic and Laboratory Medicine conference taking place in Chicago, Illinois July 29 to August 1, 2024. At ADLM, Microbix will exhibit alongside leading firms that provide tests to diagnose and direct treatment of HCV and many other infectious diseases. Microbix will thereby showcase its ever-growing portfolio of QAPs that help ensure the accuracy of antigen and molecular tests and their workflows. Also at ADLM, Microbix'll present its poster titled "Novel Hepatitis C Virus External Quality Control that is Stable at Ambient Temperature and Suitable for Use in Low- Resource Settings." The poster reviews the performance of a novel PROCEED®?FLOQ®? (RUO) QAP to support the training for and prospective quality management of POCT PCR tests that use fingerstick whole-blood samples to detect HCV. In spite of efforts to eliminate viral hepatitis, it is estimated that 58 million individuals are infected with HCV. The majority of such persons live where conventional lab-based diagnostics are inaccessible due to high costs, want of equipment or trained personnel, or lack of “cold-chain” refrigeration. HCV POCTs are therefore critical for improving test accessibility, surveillance, and treatment, with such POCTs requiring suitably designed and robust External Quality Controls to monitor the accuracy of testing. The novel Microbix HCV QAP is formatted onto a COPAN® FLOQSwab® to help achieve a consistent and accurate signal, provide room-temperature stability, and be superior to conventional HCV quality controls that must be kept frozen until use. The QAP is also whole-genome to contain all relevant PCR-test targets, works with the relevant sample-elution reagents, and has long-term stability at ambient temperatures (i.e., 2 to 30 ºC). This QAP is intended to facilitate and accelerate the rollout and adoption of POCTs for HCV, particularly for geographically or culturally-isolated persons and in low or middle-income countries. Ankündigung • May 10
Microbix Biosystems Inc. to Report Q2, 2024 Results on May 15, 2024 Microbix Biosystems Inc. announced that they will report Q2, 2024 results Pre-Market on May 15, 2024 Ankündigung • Mar 12
Microbix Biosystems Inc. Unveils Test Controls for Head and Neck Cancer Microbix Biosystems Inc. announced that it is presenting results of Quality Assessment Products ("QAPs") for supporting the quality control ("QC") of histology and PCR-based tests driven by tissue-s samples of Head and Neck cancer caused by human papilloma virus ("HPV"). Its results presentation will be made at EUROGIN 2024, an international collaborative conference and exhibition focused upon innovations in HPV research and global cancer solutions taking place in Stockholm, Sweden from March 13 to 16, 2024. While HPV is best known for causing cancers of the cervix in women, this virus family also causes cancer in other bodily tissues. Such further types of HPV-driven cancer include those of the "Head and Neck," collectively tumours inside and behind the nose, throughout the mouth (including the tongue, gums, and palate), all sections of the throat, and the voice box. Diagnosis of such cancers is made from tissue sample analyses that look for the presence of cancerous cells via histology and the presence of viral DNA by PCR. Ankündigung • Feb 24
Microbix Biosystems Inc., Annual General Meeting, Mar 27, 2024 Microbix Biosystems Inc., Annual General Meeting, Mar 27, 2024, at 13:00 US Eastern Standard Time. Agenda: To consider receiving the 2023 annual report; To consider electing directors; To consider re-appointing Ernst & Young LLP; To consider and approve with or without amendment. Ankündigung • Feb 08
Microbix Biosystems Inc. to Report Q1, 2024 Results on Feb 14, 2024 Microbix Biosystems Inc. announced that they will report Q1, 2024 results Pre-Market on Feb 14, 2024 Ankündigung • Dec 22
Microbix Biosystems Inc. Provides Earnings Guidance for the Full-Year Fiscal 2024 Microbix Biosystems Inc. provided earnings guidance for the full-year fiscal 2024. The company expects to generate meaningful sales and net earnings growth across full-year fiscal 2024. Ankündigung • Aug 05
Microbix Successfully Upgrades Logistics Software Systems Achieves “Go-Live” with New ERP and eQMS Solutions Microbix Biosystems Inc. announces its successful adoption of software to upgrade, digitize, and integrate its Enterprise Resource Planning (“ERP”) platform and electronic Quality Management System (“eQMS”). These logistics IT systems are intended to facilitate growth in sales of Microbix’s product lines and thereby enable achievement of its business objectives. Microbix announced its selection of new ERP and eQMS systems in March, 2022, with its goal being to achieve “Go-Live” with each by the end of fiscal 2023 (i.e., September 30, 2023). That goal is now achieved, with the new ERP software supporting operations from raw materials procurement through to receivables collection. In turn, processes relating to product development, SKU manufacturing, QC/QA, and staff training are now being digitized via the new eQMS system. These logistics software upgrades are deemed essential for Microbix to realize its objective of driving sales toward CAD 100 million per year while maintaining optimal quality and pricing for its customers. NetSuite® is Microbix’s chosen ERP software, approaching 30,000 unique clients with over 1,000 in the Medtech/Pharma fields. This ERP integrates seamlessly with eQMS to provide a complete and scalable solution including manufacturing, QC/QA, finance, sales & CRM, inventory control, and compliance. MasterControl® is the chosen eQMS provider, having been a market leader for over 25 years, active in over 50 countries and with over 750 Medtech clients. Its eQMS fully-digitizes manufacturing batch-production-records, testing documentation, and training processes to increase throughput and reduce errors. Ankündigung • Jul 25
Microbix Biosystems Inc. Presents Results of STI Test Controls at AACC Microbix Biosystems Inc. announced that it is presenting results of its Quality Assessment Products (“QAPs™”) for supporting the clinical use and accuracy of multiplex tests for four of the most prevalent sexually-transmitted infections (“STIs”) at the American Association of Clinical Chemistry (“AACC”) conference taking place in Anaheim, CaliforniaJuly 23 to 27, 2023. At AACC, Microbix will exhibit alongside leading firms that provide tests to diagnose and direct treatment of STIs and other infectious diseases. Microbix will thereby showcase its ever-growing portfolio of QAPs that help ensure the accuracy of antigen and molecular (i.e., “PCR”) tests and their workflows. Also at AACC, Microbix will present a poster titled “Evaluating the Performance of Emerging STI Point of Care Assays Using Novel, Room Temperature Stable CT/NG/TV/MG Positive Swab Quality Control Materials.” The poster reviews the performance of novel PROCEED®FLOQ® (RUO) QAPs to support the clinical use and accuracy of multiplex PCR tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) – four of the most prevalent STIs. Point of Care Tests (“PoCTs”) that can distinguish between STI-causing pathogens promise improved access to care and faster turnaround time from patient-sampling to test-result. However, users of such PoCTs must have accurate and robust test-control materials for quality management purposes. Microbix therefore developed a whole-workflow multiplex STI QAP desiccated on a Copan FLOQSwab® that is stable at 2-30°C and contains inactive whole-genome target pathogens. The poster evaluated its performance with multiple diagnostic platforms in current use and in development, namely the Abbott Alinity™ m STI assay, Aprimeo/Bosch Vivalytic™ STI Assay, BD MAX™ CT/GC/TV assay, Cepheid Xpert® CT/NG and TV assays, Seegene Novaplex™ CT/NG/TV/MG assay, an IVD assay in late-stage development, and a lab-developed assay. Ankündigung • Jun 14
Microbix Biosystems Inc. Presents Results of STI Test Controls at ASM Microbe Microbe FLOQ Microbix Biosystems Inc. announced that it is presenting results of its Quality Assessment Products ("QAPs™?") for supporting the clinical use and accuracy of tests for antimicrobial-resistant ("AMR") sexually-transmitted infections ("STIs") at the ASM Microbe conference of the American Society of Microbiology ("ASM"), taking place in Houston, Texas June 15-19, 2023. At ASM Microbe, Microbix will exhibit alongside leading firms that provide tests to diagnose and direct treatment of STIs and other infectious diseases. Microbix will thereby showcase its ever-growing portfolio of QAPs that help ensure the accuracy of antigen and nucleic acid (i.e., "PCR") tests and their workflows. Also at the conference Microbix will present a poster titled "Evaluating the Performance of Nucleic Acid Amplification Tests that Detect Mycoplasma genitalium and Mutations Associated with Macrolide Resistance Using Novel Quality Controls Formatted on Swabs." The poster reviews the performance of novel REDx FLOQ (IVD) and PROCEEDx™?FLOQ (RUO) ®? ®?. QAPs to support the clinical use and accuracy of test for AMR variants of the STI Mycoplasma genitalium ("Mgen"), a common cause of urethritis, cervicitis, pelvic inflammatory disease, and infertility. As is becoming increasingly common with many infections, the emergence of AMR variants of Mgen is leading to a high rate of first-line treatment failure (i.e., 44-90%). If accuracy can be ensured, PCR-based testing can greatly improve treatment outcomes, but quality-control materials to support such tests were largely unavailable. The resulting room-temperature stable QAPs demonstrate that they support testing with varied advanced PCR-assay workflows and elution buffers. Microbix is therefore pleased to be offering flocked-swab formatted QAPs that support clinically-important AMR Mgen testing as cross-platform IVD quality controls, validation, verification, and training panels, and as external quality assessment samples. Ankündigung • Jan 31
Microbix Biosystems Inc. Launches QAP to Support "Monkeypox" Testing Microbix Biosystems Inc. announced that it is launching a new quality assessment product ("QAPTM") to support molecular diagnostic ("MDx") testing for the Non-Variola Orthopoxvirus ("Mpox"), the cause of the cutaneous infection colloquially-known as "Monkeypox." From traditional low-level incidence in Central and Western Africa, incidence of Mpox surged meaningfully within many countries in 2022, leading to increased testing for this virus. However, transmission of this virus currently requires close or prolonged contact between individuals, limiting its pandemic potential. Microbix chose to create a QAP to support Mpox testing following requests from its customers that provide proficiency-testing and accreditation services to clinical laboratories (i.e., "PT" or "EQA" providers) and to prepare for the inclusion of Mpox in standard worldwide genital ulcer disease diagnostic programs. Although the frequency of testing for Mpox is currently limited, labs must become and remain accredited for such testing by PT/EQA providers. Microbix will be providing Mpox QAPs in liquid or FLOQSwab® formats for that PT/EQA need and as a result, its sales are not expected to be correlated to the rates of Mpox infection or with how much this virus is the subject of news media coverage. In otherwise healthy persons, Mpox infection is usually self-limiting and non-fatal in nature. However, Mpox viral DNA has been detected in human blood, which raises the question of whether blood-borne transmission is a possibility with this emerging pathogen. If blood-borne transmission of Mpox is proven at any future time, the need for routine screening of blood and blood products could arise. In collaboration with its PT/EQA partners, the Microbix Mpox QAP has now been validated for use across 11 leading MDx testing systems and multiple Lab Developed Tests, at 33 clinical laboratories in multiple European and Scandinavian nations. The Mpox QAP validation results may be presented by Microbix or its collaborators at a future scientific conference, in accordance with industry practices and standards. PT/EQA shipments of the Mpox QAP can now commence and Microbix expects material sales of this product starting in its current fiscal year. Ankündigung • Feb 10
Microbix Biosystems Inc. Announces Material First Sales of Viral Transport Medium Microbix Biosystems Inc. announced material first sales of its viral transport medium (generically known as VTM and branded as DxTM™) that supports Canadian RT-PCR (molecular) testing for the virus causing COVID-19 disease. First sales of 50,000 vials (approximately one lot) have now been made to a private-market client at Microbix’s targeted pricing for this newly-available product. At the request of the Government of Ontario, Microbix has created a secure and locally-based supply of high-quality VTM, any shortage of which limits capacity for COVID-19 testing. Microbix has begun its DxTM production at about 50,000 vials per week, with steps now underway to increase that rate of production to 100,000 vials per week and the objective of reaching that doubling in fiscal Second Quarter (the quarter ended March 31, 2021). Further scale-up and automation is planned to attain Ontario’s original request for production of over 400,000 vials of DxTM per week by the end of Microbix’s fiscal 2021 (September 30, 2021). Additional production lots will be released on a weekly basis starting this week. Subject to fulfilling orders from the Government of Ontario and its designates, DxTM is now available for use throughout Canada, manufactured and distributed under Microbix’s Health Canada Medical Devices Establishment License (MDEL) and its ISO quality management systems. The suitability of DxTM has been evaluated across multiple test platforms and it is being produced entirely at Microbix’s facilities in Mississauga, Ontario, with its critical ingredients and materials sourced from Canadian suppliers. Microbix remains engaged with the principal supply-chain organization supporting hospitals in Ontario to procure DxTM for testing programs within the province. However, until Microbix’s supply is procured by the Government of Ontario or its designates, DxTM will continue to be made available on a first-come-first-served basis – including to other provinces and private testing organizations. Ankündigung • Jan 29
Microbix Biosystems Inc. Announces Commercial Availability of Its Viral Transport Medium Microbix Biosystems Inc. announced the commercial availability of its viral transport medium (VTM) to support Canadian RT-PCR (molecular) testing for the virus causing COVID-19 disease. At the request of the Government of Ontario, Microbix has created a secure and locally-based supply of high-quality VTM, any shortage of which limits capacity for COVID-19 testing. Microbix has begun its VTM production at 50,000 vials per week using semi-automated methods and, again at Ontario's request, is targeting more-automated production of over 400,000 vials per week by the end of its fiscal 2021. DxTM is now available for use throughout Canada, manufactured and distributed under Microbix's Health Canada Medical Devices Establishment License (MDEL) and its ISO quality management systems. The suitability of DxTM has been evaluated across multiple test platforms by Public Health Ontario - based on
trials of hundreds of samples provided by Microbix. DxTM is produced entirely at Microbix's facilities in Mississauga, Ontario and its critical ingredients and materials are sourced from Canadian suppliers. Ankündigung • Jan 21
Microbix Biosystems Inc., Annual General Meeting, Mar 30, 2021 Microbix Biosystems Inc., Annual General Meeting, Mar 30, 2021. Ankündigung • Oct 16
Microbix Launches New STI-Related Quality Assessment Products Microbix Biosystems Inc. announced its creation, external verification, and registration of new quality assessment products (QAPs) to help ensure the accuracy of workflows at labs conducting nucleic acid testing for sexually-transmitted Mycoplasma genitalium (Mgen) infections. Mgen is a small bacteria that causes widespread and persistent infection of the urinary and reproductive tracts in men and women. Mgen infections impact as many as one-in-five sexually-active adults, are a frequent cause of urethral or reproductive tract inflammation, and a cause of infertility. Mgen infections can be treated with antibiotic therapy, although drug-resistant strains are a growing problem. In spite of its relative ubiquity, testing for Mgen is not widespread. This has been largely due to very limited availability of validated control materials to help ensure the accuracy and reliability of nucleic acid tests for Mgen infections. Mgen is notoriously difficult to culture ex-vivo, making it extremely challenging to create adequate quantities of test workflow quality control materials. Microbix has overcome this challenge and can now supply quantities sufficient to meet expected commercial demand. Using its expertise and that of collaborators, Microbix has created and is now launching whole-genome and whole-process QAPS for nucleic acid Mgen tests, branded as REDx Mycoplasmagenitalium positive or negative controls and available in a refrigeration-stable liquid vial format. These new Mgen QAPs have achieved their “CE mark” to permit sale across the EU, have been added under Microbix’s U.S. FDA establishment registration, and are targeted to become available in Australia and Canada. Microbix has created its Mgen QAPs to support laboratory proficiency testing and accreditation, test development or lab training, and clinical lab workflows. External validation of these products has been completed with multiple well-recognized makers of nucleic acid tests for Mgen infections and multiple international laboratory proficiency testing and accreditation organizations. As for all Microbix’s QAPs, the Mgen-test variants are designed to provide support for quality management systems regardless of what specific tests are in use and additional to whatever on-board controls are used within particular tests. As such they supplement accuracy without risk to patients. Ordering enquiries should be directed to Microbix or its distributors: Alpha-Tec Systems Inc., Diagnostic International Distribution S.p.A., Labquality Oy, The Medical Supply Company of Ireland, and R-Biopharm AG. Microbix believes these Mgen products are complimentary to its QAPs for high-risk variants of Human Papilloma Virus (HPV). With Mgen and HPV QAPs (that support testing workflows for HPV types 16, 18 and 45), Microbix has a growing line of products to support testing for sexually-transmitted infections. Microbix remains committed to continuing to build its portfolio of innovative, proprietary, and branded QAPs – currently focused within the respiratory and sexually-transmitted segments of infectious disease. Ankündigung • Sep 24
Microbix Biosystems Inc. Will Present About the Performance of Its Covid- 19 In-Vitro Diagnostics (Ivd) Quality Assessment Products Microbix Biosystems Inc. announced it is has been invited to present about the performance of its COVID- 19 in-vitro diagnostics (IVD) quality assessment products at "ECCVID," a virtual conference on Coronavirus disease organized by the European Society for Clinical Microbiology and Infectious Diseases (ESCMID), taking place September 23-25, 2020. The abstract presentation is titled "Novel SARS-CoV-2 Full-Genome Material For Use In A Swab-based Formulation As A Multi -Platform NAAT Quality Control." It reviews the performance of Microbix's novel, innovative, and proprietary REDxTMFLOQ® SARS-CoV-2 product - A tool for helping to ensure the accuracy of clinical laboratory "RT-PCR" testing for active infection with the virus causing COVID-19 disease. The results demonstrate that Microbix's COVID-19 quality assessment products (QAPsTM) contain all required nucleic acid targets and are formulated for compatibility across many widely-used RT-PCR tests. Microbix believes these results show it is addressing the need for workflow controls to effectively support the quality objectives of clinical labs testing for SARS-CoV-2 infections across many diagnostic instrument platforms. It also believes that this QAPs product will assist with the provision of optimal healthcare globally and that it represents a meaningful new revenue opportunity for Microbix. The abstract presentation was authored by six members of Microbix's product development (R&D), operating, and customer support teams and details the REDxFLOQ SARS-CoV-2 performance results in a complete and succinct fashion. It is being presented by Microbix's Director of Quality Assessment Products (QAPsTM), Pavel Zhelev. The full slides will be made available on the company website, www.microbix.com, after their presentation at ECCVID and includes Microbix's thankful acknowledgement of ten collaborator organizations across Europe, North America, and Scandinavia. Ankündigung • Aug 16
Microbix Biosystems Inc. to Report Q3, 2020 Results on Aug 14, 2020 Microbix Biosystems Inc. announced that they will report Q3, 2020 results at 11:00 AM, GMT Standard Time on Aug 14, 2020