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Microbix Assisting EMQN With Novel Genetic-Test EQA Program

Microbix Assisting EMQN With Novel Genetic-Test EQA Program

Microbix正在協助EMQN開展新的基因檢測EQA項目
GlobeNewswire ·  12/10 20:00

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

用於快速識別易受抗生素引起的聽力損失的患者

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.

位於安大略省的密西沙加和英國曼徹斯特,2024年12月10日(全球新聞網)—— Microbix Biosystems Inc.(TSX:MBX,OTCQX:MBXBF,Microbix),一家生命科學創新者、製造商和出口商,以及EMQN CIC(EMQN),全球實驗室外部質量評估(「EQA」)項目的供應商,宣佈啓動一個項目,以支持準確識別那些攜帶與抗生素治療後聽力下降的基因變異相關的患者。

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.

這是首個此類EQA項目,旨在確保評估患者是否攜帶Mt-RNR100萬.1555A>G基因變異的現場檢測(「POCT」)和急性護理實驗室的能力。據估計,每500人中就有1人攜帶這種變異,暴露於氨基糖苷類抗生素時可能導致嚴重並且不可逆轉的聽力損失。這類抗生素包括慶大黴素、克林黴素、鏈黴素和託布黴素,用於治療多種「革蘭氏陰性」細菌感染。特別是新生兒被認爲面臨細菌敗血症的風險——這種生命威脅狀況如果不及時用適當的抗生素和其他急救醫療照顧來治療,可能導致多臟器衰竭和死亡。

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.

Microbix生產的質量評估產品(「QAPs」)被格式化到Copan FLOQSwabs上,正用於此EMQN EQA項目,以幫助評估這種急性護理基因檢測的能力和準確性。QAPs提供樣本,參與者可以像處理頰部或口腔拭子一樣處理這些樣本,使他們能夠驗證Mt-RNR1檢測的準確性。在訂閱這一EMQN項目後,參與者每兩個月將收到三個樣本(每年18個),幫助他們確保持續的檢測準確性,從而儘可能做出最可靠的診斷。

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."

EMQN的銷售和運營董事Sean評論道:「在這一具有開創性和重要性的新EQA項目中,能夠得到Microbix的協助讓我感到非常高興。急救醫生需要這些信息來評估抗生素治療的風險與收益,沒有患者應該面臨終身的聽力損失,而在這些風險的識別測試已經可用的情況下。」

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."

Microbix的首席執行官兼總裁Cameron Groome也評論道:「我們很高興能夠幫助創建用於臨床重要決策的EQA。我們的專業知識與EMQN和Copan的專業知識結合,以確保爲全球患者提供準確的測試和適當指導的治療。這個QAP標誌着Microbix在支持基因檢測準確性方面的首次參與,進一步增強了我們在傳染病領域的既有影響力及在腫瘤學中的新角色。」

UK and international labs can enroll in this EQA program (code POCT MT-RNR1 25) via EMQN CIC at and enquiries about Microbix QAPs can be directed to customer.service@microbix.com.

英國和國際實驗室可以通過EMQN CIC報名參加此EQA項目(代碼POCt Mt-RNR1 25),有關Microbix QAP的諮詢可以發郵件至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.

關於EMQN CIC
EMQN是一家位於英國曼切斯特的公司,通過外部質量評估(EQA)方案爲人類基因組檢測社區提供質量保證工具和專業知識。其工作幫助保證最佳的分子診斷程序、分析性能和臨床解釋。EMQN的高素質評估小組引以爲豪其思想領導地位,並承諾定期出版最佳實踐指南和其他針對分子診斷領域的信息。EMQN獲得了英國認證服務(UKAS)對EQA方案提供者國際標準ISO 17043的認證。

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.

關於Microbix Biosystems Inc.
Microbix Biosystems Inc.爲人類健康創建專有生物產品,擁有超過100名技術熟練的員工,銷售現在每月目標爲200萬加元或更多。它製造並出口一系列關鍵成分和設備,服務於全球診斷行業,特別是免疫測定用抗原和其實驗室質量評估產品(QAPs),這些產品支持臨床實驗室能力測試,促進測定的開發和驗證,或幫助確保臨床診斷工作流程的質量。其抗原驅動着大約100個診斷製造商的抗體測試,而QAPs則出售給臨床實驗室認證機構、診斷公司和臨床實驗室。Microbix的QAPs目前在超過30個國家可用,並得到國際分銷商網絡的支持。Microbix已獲得ISO 9001和13485認證,註冊於美國FDA,註冊於澳大利亞TGA,獲得加拿大健康部門的許可,並提供符合IVDR要求的CE標誌產品,覆蓋整個歐盟。

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.

前瞻性信息
本新聞稿包含「前瞻性信息」,該術語在適用的證券法中有定義。前瞻性信息包括但不限於對測試、EQA計劃、EMQN、Copan或其相關性,Microbix的產品或服務、業務及業務結果、目標或展望、與財務結果和穩定性相關的風險、如其報告中提到的發展項目、法規遵從和批准、向外國司法管轄區的銷售、工程和施工、生產(包括對成本、質量、數量或交付時間的控制)、貨幣兌換匯率、維持足夠的營運資金或以可接受的條款或根本不以任何形式籌集新資本的能力,以及其他類似的關於預期未來事件、狀況或結果的表述,這些內容不是歷史事實。這些表述反映了管理層當前的估計、信念、意圖和期望;它們並不保證未來的表現。Microbix提醒,所有前瞻性信息本質上是不確定的,實際的表現可能受到多種重要因素的影響,其中一些超出了它的控制範圍。因此,實際未來事件、情況和結果可能與前瞻性信息中表達或暗示的估計、信念、意圖和期望有重大差異。所有表述均以本新聞稿的日期爲準,並代表Microbix在本新聞稿日期的判斷,並且Microbix沒有義務更新或修改任何前瞻性信息。

Please visit or for recent Microbix news and filings.

請訪問或以獲取最新的Microbix資訊和文件。

For further information, please contact Microbix at:

如需進一步信息,請聯繫Microbix:

Cameron Groome, CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets
(647) 203-8793 ir@microbix.com
卡梅倫·格魯姆,首席執行官
(905) 361-8910
吉姆·庫裏,
首席財務官
(905) 361-8910
黛博拉·霍尼格,
投資者關係
阿德萊德資本市場
(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.

版權 2024 Microbix Biosystems Inc.
Microbix、DxTm、Kinlytic 和 QAPs 是 Microbix Biosystems Inc. 的商標。
Copan、FLOQ 和 FLOQSwab 是 Copan Italia S.p.A. 的商標。


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