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For Rapid Identification of Patients Susceptible to Antibiotic-Induced Hearing LossMISSISSAUGA, 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 CICEMQN 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 InformationThis 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. Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings. For further information, please contact Microbix at: Cameron Groome, CEO(905) 361-8910Jim Currie, CFO(905) 361-8910Deborah Honig, Investor RelationsAdelaide Capital Markets(647) 203-8793 ir@microbix.com Copyright © 2024 Microbix Biosystems Inc. Microbix®, DxTM™, Kinlytic®, and QAPs™ are trademarks of Microbix Biosystems Inc.Copan®, FLOQ®, and FLOQSwab® are trademarks of Copan Italia S.p.A.

MADERA, Calif., June 25, 2024 /PRNewswire/ -- What if a gentle swab of an infant's cheek was all it took to know if giving them a common antibiotic could also lead to long-term hearing loss? Continue Reading Dr. Jeremy Woods, Valley Children's Precision Medicine Director, with machine that tests for changes in the MT-RNR1 gene Valley Children's Hospital, located in Madera, California (PRNewsfoto/Valley Children's Healthcare) That is what Valley Children's Precision Medicine Program is doing: the team is the first in the nation to use a revolutionary genetic test that can quickly let a doctor know if their tiny patient is at higher risk of hearing damage from a type of antibiotic known as an aminoglycoside. Once a doctor knows that the baby has a particular version of a key hearing gene, they can then choose a different course of care to treat an infection. "Genes are like the individual instructions in a book that tell the body how to build and work, so understanding them is important in creating a treatment plan for each patient," said Dr. Jeremy Woods, Valley Children's geneticist and director of the Precision Medicine Program. Aminoglycosides are a class of antibiotics often used to treat infections for infants in the neonatal intensive care unit (NICU). But in addition to attacking bacteria, the medicines can also attack human proteins that are vital to hearing development. That's not usually a problem, but for babies born with certain variants of the MT-RNR1 gene, the risk for aminoglycoside-induced hearing loss (AIHL) is much greater. Insights suggest that this could be the explanation for at least 1% of hearing loss that occurs in children before language development, and likely more. The problem until now was being able to check the baby's genetic "map" quickly if they got sick. Valley Children's has solved that with a simple, non-invasive test. A small saliva sample from the baby's cheek is then analyzed by a special machine that tests for changes in the MT-RNR1 gene. The machine is no larger than an inkjet printer and can deliver results to physicians in under an hour when time is of the essence. Valley Children's Precision Medicine team is conducting MT-RNR1 rapid testing for patients outside of the hospital, with plans to standardize this process for babies in the hospital later this year. "Previously, we would have to wait weeks for the results of MT-RNR1 genetic testing. Now, we can have results back in under an hour," Dr. Woods said. "That gives us plenty of time to choose a safer antibiotic to treat a seriously ill baby." This life-changing advancement is one of several innovative tools pioneered by Valley Children's Precision Medicine Program. Earlier this year, the hospital began using an advanced genetic testing module as part of the electronic patient information system. This system allows providers to effortlessly order a comprehensive genetic test (whole genome sequencing) that includes one or both parents and provides instant care recommendations based on a child's specific genetic map. Valley Children's was also one of only five institutions to participate in a Medi-Cal pilot program called Project Baby Bear, which used rapid whole genome sequencing to improve the care for critically ill infants with undiagnosed illnesses. "Standardizing genome testing in the NICU underscores our commitment to utilizing cutting-edge technology and genetics to provide our patients with more than the best care, but the specialized kind of care they need," Dr. Woods said. About Valley Children's Healthcare Valley Children's Healthcare provides Central California's only high-quality, comprehensive care exclusively for children, from before birth to young adulthood. Our network offers highly specialized medical and surgical services to care for children with conditions ranging from common to the highly complex at its 358-bed stand-alone children's hospital that includes 28 NICU beds at partner hospitals. In addition, the Valley Children's Healthcare network includes specialty care centers, pediatric primary care practices and women's health services. Our family-centered, pediatric services extend from a leading pediatric cancer and blood diseases center on the West Coast, and a pediatric heart center known for its expertise and pioneering treatments, to an 88-bed Regional Level IV neonatal intensive care unit (NICU), the highest-level referral center between Los Angeles and the Bay Area. Valley Children's was the first children's hospital west of the Rockies to receive Magnet Nursing designation, the highest nursing benchmark in the world. In 2023, U.S. News and World Report again named Valley Children's one of the best children's hospitals in the country in seven pediatric specialties. With more than 670 physicians and 3,500 staff, Valley Children's delivers high-quality, comprehensive care to more than 1.3 million children from Kern County to the state capital and from the Central Coast to the Sierra. For more information, please visit SOURCE Valley Children's Healthcare