IVDR Compliance and CE Certifications for REDx? QAPs
MISSISSAUGA, Ontario, Oct. 03, 2024 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix?), a life sciences innovator, manufacturer, and exporter, announces that it has upgraded its European Union (“EU”) regulatory compliance for its diagnostic assay quality assessment products (“QAPs?”). Specifically, Microbix has obtained recognition of its quality management system compliance with the EU In Vitro Diagnostics Regulation (“IVDR”) and Conformité Européenne Certification (“CE Certification”) for an initial portfolio of 11 REDx? QAPs – two essential regulatory achievements in order for Microbix to have complete access to EU-regulated markets and fully serve its customers.
IVDR came into force in 2022 and greatly increases the burden on makers of diagnostic assays and related medical devices to demonstrate the safety, efficacy, and consistency of their products. While a transition period exists for “Legacy Devices” that entered the EU market prior to 2022, no new regulated products can be sold in the EU unless their makers first achieve IVDR compliance and CE Certification. Accordingly, Microbix has considered it essential to meet these new and challenging regulatory requirements.
Microbix has now achieved its EU Quality Management System Certificate for IVDR and CE Certification for an initial portfolio of 11 of its REDx brand QAPs. This achievement follows the careful evaluation of the products and an audit of Microbix’s systems and facilities – both conducted by a “Notified Body” agency to which the EU has delegated authority for IVDR and CE certifications.
REDx QAPs are used to support the Quality Management System needs of accredited clinical labs running assays that directly drive patient diagnoses and clinical decision-making. In the EU, such clinical labs must adhere to the ISO 15189 quality standards and regularly use IVDR-compliant quality assessment products.
Via these accreditations, Microbix has fully validated its QAPs development processes. CE Certifications can thereby be obtained for (i) QAPs already available in the EU as Legacy Devices, and (ii) newly-created QAPs to be used in clinical settings (i.e., more “REDx” QAPs). Again, Microbix considers IVDR and CE certifications to be essential to support its EU-focused customers and for continuing its sales growth.
Microbix is a technical leader in creating QAPs, which it designs to fully-emulate patient test-specimens while being highly-stable and non-infectious. QAPs are used to train staff, qualify instruments for use, and to assess the extent to which lab quality management system needs are being met. Microbix QAPs support diagnostic assays for infectious diseases across the major categories of gastrointestinal, respiratory, and sexually-transmitted diseases, for assessing cancer risk, and for other uses. QAPs are available as liquid samples, on COPAN? FLOQSwabs?, and as tissue-sample mimetics (i.e., in “FFPE” format).
Microbix’s full catalogue of QAPs is available on its website, https://microbix.com. Price and order enquiries should be directed to [email protected].
About Microbix Biosystems Inc. Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and sales now targeting C$ 2.0 million per month. It makes and exports a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs?) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
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 reagents or media to support molecular diagnostic testing (e.g., its DxTM? for patient-sample collection). Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of IVDR and CE certifications, their benefits or relevance, Microbix’s products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. Microbix cautions that all forward-looking information is inherently uncertain and actual performance may be affected by many material factors, some of which are beyond its control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information.
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Copyright ? 2024 Microbix Biosystems Inc. Microbix?, DxTM?, Kinlytic?, QAPs? and REDx? are trademarks of Microbix Biosystems Inc. Copan?, FLOQ?, and FLOQSwab? are trademarks of Copan Italia S.p.A.
