Clinical Trials to Get Underway With Multiplo(R) Complete Syphilis (TP/nTP) Antibody Test - A Potential Game Changer to Address Syphilis Health Crisis in Canada
Clinical Trials to Get Underway With Multiplo(R) Complete Syphilis (TP/nTP) Antibody Test - A Potential Game Changer to Address Syphilis Health Crisis in Canada
HALIFAX, NS / ACCESSWIRE / August 13, 2024 / Today, MedMira Inc. (MedMira) (TSXV:MIR) announces it will conduct full clinical trials for its unique Multiplo Complete Syphilis (TP/nTP) Antibody Test (Multiplo TP/nTP) with the goal of getting it licensed in Canada. The new Multiplo TP/nTP will provide a complete system which combines screening and confirmation in one test. Just announced by Health Minister Mark Holland, the clinical trial is happening in partnership with REACH Nexus at St. Michael's Hospital's MAP Centre for Urban Health Solutions with funding from the Canadian Institute of Health Research (CIHR).
今天,MedMira公司(MedMira)(TSXV:MIR)宣布将开展其独特的多倍完整梅毒(TP / nTP)抗体检测(Multiplo TP / nTP)的全面临床试验,目的是在加拿大获得许可证。新的Multiplo TP / nTP将提供一种完整的系统,将筛查和确认结合在一次检测中。该新闻刚被卫生部长Mark Holland宣布,临床试验将与REACH Nexus以及St. Michael's Hospital的MAP Urban Health Solutions中心合作进行,并获得了加拿大卫生研究所(CIHR)的资助。 这是抗击梅毒不断增长的重要里程碑。MedMira独特的和专利的Multiplo TP / nTP提供了一种高质量快速的现场检测(POC)检测,可在支持医疗保健系统的同时立即筛查和确认,并提供最快,最具成本效益的测试解决方案。通过利用其独特的专利RVF技术,MedMira提供了唯一商业可得的筛查和确认检测,从采样到易于读取的结果仅需不到3分钟,用于检测活动梅毒感染并得到立即结果。“在REACH Nexus at MAP的巨大支持下,我们已经能够展示我们卓越的技术以及我们产品的高质量和灵活性。这导致了最近的奖项并使得MedMira能够将这个非常必要的产品带到加拿大市场。没有MAP科学家及其团队以及CIHR的资金支持,加拿大人将无法从这个必要的测试中受益。因此,我们感谢支持并相信我们的技术和产品。”MedMira的首席执行官陈宏达说。 “我们的Multiplo TP / nTP在各个方面都是独特的,没有可比的检测解决方案可以提供我们的速度,质量和成本效益。我们真切地感到这是加拿大医疗保健部门的一个美好补充,并将使医疗保健提供者在出现活动梅毒感染时能快速采取行动,同时减轻全系统的财务压力。” Multiplo TP / nTP测试将把检测T螺旋体(TP)和非螺旋体(nTP)抗体融合到单个诊断工具中。通过定位与活动和过去感染相关的生物标志物,此测试提供了一个全面的解决方案,它将全球测试协议中使用的筛查和确认阶段相结合。与传统的梅毒检测不同,我们创新的,用户友好的和耐用的诊断工具解决了对活动梅毒感染进行灵活,准确和具有成本效益的检测需求的不断增长。Multiplo TP / nTP不仅检测暴露于TP,同时也通过同时确定非螺旋体和螺旋体抗体来确定活动感染状况。
This significant achievement is a major milestone in the fight against the rising growth of syphilis. MedMira's unique and patented Multiplo TP/nTP provides a high-quality rapid point-of-care (POC) test to screen and confirm instantly while supporting the health care system with the fastest and most cost-effective testing solution. By utilizing its unique and patented RVF technology, MedMira offers the only commercially available combined screening and confirmation test which takes less than 3 minutes (from sample collection to easy-to-read results) for the detection of active syphilis infection with immediate results.
“我们需要更多批准在加拿大使用的快速现场检测(POC)选项,以抵达未经诊断的人群,并检测艾滋病毒,梅毒和其他血液传播的感染和性传播感染(STBBIs)。”REACH和MAP科学家,圣迈克尔医院(Unity Health Toronto)的REACH主任Sean b. Rourke博士说。“我们非常期待与MedMira合作进行的伙伴关系和实施科学工作将对加拿大人和全球人民产生真实的影响。
"With the tremendous support of REACH Nexus at MAP, we have been able to demonstrate our superior technology and with it our products high quality and flexibility. This led to the most recent award and enables MedMira to bring this very much needed product to the Canadian market. Without scientists and their team at MAP and the funding from CIHR, Canadians would not have been able to benefit from this essential test. Hence, we are grateful for the support and believe in our technology and products" says Hermes Chan, CEO of MedMira." Our Multiplo TP/nTP is unique in every way and there is no comparable testing solution that can provide our speed, quality and cost-effectiveness. We truly feel this is a wonderful addition to the Canadian health care sector and will enable for health care providers to act swiftly in cases of active syphilis infections while unburden the financial strain on the overall system."
得益于加拿大卫生研究所(CIHR)的资助,Sean Rourke博士及其REACH Nexus团队正在领导努力通过与加拿大体外诊断开发商,医疗保健提供者,社区利益相关者和有生活经验的人,研究人员,卫生部和公众卫生机构进行协作,将新的POC测试带到加拿大市场-同时解决这些流行病对加拿大人的负担。
The Multiplo TP/nTP test integrates the detection of both treponemal (TP) and non-treponemal (nTP) antibodies into a single diagnostic tool. By targeting biomarkers associated with both active and past infections, this test offers a comprehensive solution that combines the screening and confirmation phases used in global testing protocols. Unlike traditional syphilis tests, our innovative, user-friendly, and durable diagnostic tool addresses the increasing need for flexible, accurate, and cost-effective detection of active syphilis infection. The Multiplo TP/nTP not only detects exposure to TP but also determines an active infection status by simultaneously identifying both non-treponemal and treponemal antibodies.
“我们解决不断增长的STBBIs数量的方法是加拿大的游戏规则改变者,”Rourke博士说。“并非每个人都可以获得他们所需的STBBIs检测,因为存在健康不平等,歧视和各种形式的歧视。我们需要使快速测试(获得加拿大卫生部批准的POC和自我测试(家庭使用))民主化,以便所有加拿大人都能获得他们需要的测试,以便在最好的时间和地点为他们自己的健康和福祉做出决策。”
"We need more rapid point-of-care (POC) testing options approved in Canada to reach the undiagnosed with HIV, syphilis and other blood-borne infections and sexually transmitted infections (STBBIs)" said Dr. Sean B. Rourke, director of REACH and MAP scientist at St. Michael's Hospital (Unity Health Toronto). "We are very excited about the partnership and implementation science work we are doing with MedMira that will have real-life impacts for Canadians, and for people around the world.
MedMira以及REACH Nexus和MAP的合作伙伴们已经确定了西部加拿大的临床和社区站点作为下一个“测试,治疗和连接”临床试验和实施科学研究的理想位置,前提是获得加拿大卫生部的授权。
With funding from the Canadian Institutes of Health Research (CIHR), Dr. Rourke and his team at REACH Nexus is leading efforts to address these epidemics by working collaboratively with Canadian in vitro diagnostic developers, health care providers, community stakeholders and people with lived experience, researchers, health ministries and public health to bring new POC tests to market here in Canada - while also addressing the burden of these epidemics to Canadians at the same time.
关于Unity Health Toronto联系
"The approach we are taking to addressing the rising number of STBBIs are game-changers for Canada," says Dr. Rourke. "Not everyone has access to the testing they need for STBBIs because of health inequities, stigma and various forms of discrimination. We need to democratize rapid testing - get more POC and self-testing (for use at home) approved by Health Canada - so that all Canadians have access to the testing they need to make decisions about their health and wellbeing, when and where it's best for them."
REACH Nexus是一个雄心勃勃的全国性研究团队,致力于研究如何在加拿大解决HIV,丙型肝炎和其他性传播和血液传播感染(STBBIs)。他们的重点是接触未经诊断的人群,实施和推广新的测试选择,加强与医疗保健的联系,改善预防措施的选择(PreP和PEP),以及消除歧视。我们与生活在HIV的人;社区组织;前线服务提供商;医疗保健提供商和决策者;公共卫生机构;研究人员;商业领袖;行业合作伙伴以及联邦,省级和区域性政策制定者合作伙伴关系。欢迎在其官网上了解更多。 游戏规则改变者 加拿大医疗保健部门的一个美好补充
MedMira along with their partners from REACH Nexus and MAP have identified clinical and community sites in the Western part of Canada as an ideal location for this next "test, treat and connect" clinical trial and implementation science study, subject to Health Canada's authorization.
对于此次实施科学研究,MedMira与REACH Nexus和MAP的合作伙伴们确定了西部加拿大的临床和社区场所为理想位置,前提是获得加拿大卫生部的授权。
MedMira's focus on syphilis is based on the tremendous impact of this sexually transmitted disease on global health. In 2018 alone, the European CDC reported about 34,000 new confirmed cases of syphilis with a 70% increase in the notification rate in 2017 compared to 2010. They also concluded that for the first time since the early 2000s EU/EEA countries reported more syphilis cases than HIV. Since treatments that can prevent the progression of syphilis are available, rapid diagnosis and treatment of infected individuals along with the rapid identification of sexual contacts is a high priority.
麦德米拉的关注点是梅毒,在全球健康方面造成了巨大的影响。仅在2018年,欧洲疾病预防控制中心报告了约34,000例新的梅毒确诊病例,与2010年相比,通报率增长了70%。欧洲疾病预防控制中心还得出结论,EU / EEA国家在首次自2000年以来报告了比HIV更多的梅毒病例。由于可用于预防梅毒进展的治疗,因此快速诊断和治疗感染者以及快速识别性接触者是高度优先的。
About REACH Nexus at St. Michael's Hospital's MAP Centre for Urban Health Solutions (Unity Health Toronto network)
关于Unity Health Toronto网络的REACH Nexus位于圣迈克尔医院的MAP城市健康解决方案中心
REACH Nexus is an ambitious national research group working on how to address HIV, Hepatitis C, and other sexually transmitted and blood-borne infections (STBBIs) in Canada. Their focus is on reaching the undiagnosed, implementing and scaling up new testing options, strengthening connections to care, improving access to options for prevention (PrEP and PEP) and ending stigma. We work in collaboration and partnership with people living with HIV; community-based organizations; front-line service providers; healthcare providers and decision makers; public health agencies; researchers; business leaders; industry partners, and federal, provincial and regional policymakers. Follow us more on LinkedIn and Twitter.
REACH Nexus是一个雄心勃勃的全国性研究团队,致力于研究如何在加拿大解决HIV,丙型肝炎和其他性传播和血液传播感染(STBBIs)。他们的重点是接触未经诊断的人群,实施和推广新的测试选择,加强与医疗保健的联系,改善预防措施的选择(PreP和PEP),以及消除歧视。我们与生活在HIV的人;社区组织;前线服务提供商;医疗保健提供商和决策者;公共卫生机构;研究人员;商业领袖;行业合作伙伴以及联邦,省级和区域性政策制定者合作伙伴关系。欢迎在其官网上了解更多。 LinkedIn和页面。推特.
About MedMira
关于麦德米拉
MedMira is a leading developer and manufacturer of Rapid Vertical Flow diagnostics. The Company's tests provide hospitals, labs, clinics, and individuals with instant disease diagnosis, such as HIV, Syphilis, Hepatitis, and SARS-CoV-2, in just three easy steps. The Company's tests are sold globally under the REVEAL, REVEALCOVID-19, Multiplo and Miriad brands. Based on its patented Rapid Vertical Flow Technology, MedMira's rapid HIV test is the only one in the world to achieve regulatory approvals in Canada, the United States, China and the European Union. MedMira's corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada. For more information visit medmira.com and medmira.ca. Follow us on Twitter and LinkedIn.
MedMira是快速垂直流诊断测试的领先开发商和制造商。该公司的测试提供了医院,实验室,诊所和个人即时疾病诊断,例如HIV,梅毒,肝炎和SARS-CoV-2,只需三个简单的步骤就可以完成。该公司的测试在全球范围内以REVEAL,REVEALCOVID-19, Multiplo和Miriad品牌销售。基于其专利的快速垂直流技术,MedMira的快速HIV测试是全世界唯一一款在加拿大,美国,中国和欧洲联盟获得监管批准的测试。位于加拿大新斯科舍省哈利法克斯的MedMira公司的企业总部和制造设施。欲知更多信息,请访问其官网medmira.ca。 medmira.com和页面。本新闻稿包含前瞻性声明,其中涉及风险和不确定性,并反映了公司关于未来事件的当前预期,包括有关可能的监管批准,产品推出,未来增长和新业务机会的声明。实际情况可能会与此处所述有所不同,并取决于许多因素,包括但不限于不断变化的市场条件,临床研究的成功和及时完成,与监管批准过程相关的不确定性,建立企业间联盟以及其他风险。。在推特上关注我们推特和页面。LinkedIn.
This news release contains forward‐looking statements, which involve risk and uncertainties and reflect the Company's current expectation regarding future events, including statements regarding possible regulatory approval, product launch, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings.
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Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
TSX tsx Venture交易所及其监管服务提供商(如TSX Venture交易所的政策中所定义的那样)不承担此发布的充分性或准确性的责任。
MedMira Contact
MedMira联系方式
Markus Meile
Chief Financial Officer
MedMira Inc.
ir@medmira.com
马库斯·迈勒
致富金融(临时代码)
MedMira公司
ir@medmira.com
Unity Health Toronto contact
Communications@unityhealth.to
通信@unityhealth.to
SOURCE: MedMira, Inc.
来源:MedMira, Inc.
译文内容由第三方软件翻译。