Microbix Assisting EMQN with Novel Genetic-Test EQA Program

For Rapid Identification of Patients Susceptible to Antibiotic-Induced Hearing Loss

MISSISSAUGA, Ontario and MANCHESTER, United Kingdom, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, and EMQN CIC (EMQN), a global supplier of laboratory external quality assessment (“EQA”) schemes for human genomic testing, announce the go-live of a program to support the accurate identification of patients who carry a gene-variant associated with increased susceptibility to hearing loss following treatment with a widely-used class of antibiotics.

This first-of-its kind EQA program is intended to help ensure the proficiency of Point-of-Care Testing (“POCT”) and acute-care labs that are assessing whether patients carry the MT-RNR1 m.1555A>G gene variant. It is estimated that one in 500 persons carry this variant that can lead to profound and irreversible hearing loss upon exposure to aminoglycoside antibiotics. This class of antibiotics include Gentamycin, Kanamycin, Streptomycin, and Tobramycin, which are used to treat a wide range of “gram negative” bacterial infections. Of particular concern are newborn babies who are suspected to be at risk of bacterial sepsis – a life-threatening condition that can lead to death from multi-organ failure if not treated promptly with appropriate antibiotic drugs and other acute medical care.

Microbix-produced quality assessment products (“QAPs™”), formatted onto Copan® FLOQSwabs®, are being used in this EMQN EQA program to help assess the proficiency and accuracy of such acute care genetic testing. The QAPs provide samples that participants can process like cheek or buccal swabs, enabling them to verify the accuracy of MT-RNR1 assays in their POCT. With a subscription to this EMQN program, participants will receive three samples every two months (18 per year), helping them to ensure the accuracy of their testing on an ongoing basis and thereby make the most reliable diagnoses possible.

Sean Sales, Operations Director at EMQN, commented, “It has been a pleasure to have Microbix’s assistance in making the QAPs for this groundbreaking and important new EQA program. Acute care physicians need the information to be able to evaluate the risk-benefit of antibiotic treatments and no patient should have to face a lifetime of hearing loss when tests to identify this risk are available.”

Cameron Groome, CEO and President at Microbix also commented, “We’re pleased to help enable the creation of EQA for this clinically-important decision-making. Our expertise was joined to that of EMQN and Copan to ensure that accurate testing and properly-directed treatment is available for patients worldwide. This QAP marks Microbix’s entry into supporting the accuracy of genetic tests, adding to our established presence in infectious diseases and emerging role in oncology.”

UK and international labs can enroll in this EQA program (code POCT MT-RNR1 25) via EMQN CIC at https://www.emqn.org/our-eqa-schemes/ and enquiries about Microbix QAPs can be directed to customer.service@microbix.com.

About EMQN CIC
EMQN is a Manchester, UK based company that provides quality assurance tools and specialized knowledge to the human genomic testing community through External Quality Assessment (EQA) schemes. Its work helps guarantee the best possible molecular diagnostic procedure, analytical performance, and clinical interpretation. EMQN’s highly qualified peer group of assessors take pride in their thought leadership position and are committed to regularly publishing best practice guidelines and other information for the molecular diagnostics field. EMQN is accredited by the United Kingdom Accreditation Service (UKAS) to the international standard for EQA scheme providers, ISO 17043.

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 or more 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 IVDR compliant CE marked products across the EU.

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 the tests, the EQA program, EMQN, Copan, or their 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 a number of 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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