Zomedica完成其Truforma™护理点诊断平台和第一个测定，犬总T4的验证
Zomedica Pharmaceuticals Corp. Press Release
遇到Qorvo的主要发展里程碑
Ann Arbor，Mich。，2020年4月21日（新闻界）-Zomedica Pharmaceuticals Corp.(NYSE American: ZOM) ("Zomedica" or the "Company"), a veterinary diagnostic company, announced today that it has completed the verification of TRUFORMA™, its point-of-care diagnostic biosensor platform, and the first assay, Canine total T4 ("tT4") thyroxine.
与Qorvo毕奥echnologies, LLC ("Qorvo"), a wholly-owned subsidiary of Qorvo, Inc., Zomedica is developing what both companies believe may be a first-of-its-kind, complete thyroid and adrenal detection platform that uses proprietary, non-optical Bulk Acoustic Wave ("BAW") sensor technology. The BAW sensor is a proven semiconductor technology used in telecommunications and aerospace markets. The Company believes that BAW technology has the potential to improve veterinary diagnostics by delivering reference laboratory accuracy and test performance to the veterinary clinic at the point-of-care.
TRUFORMA™ platform verification is a critical milestone on the path to transfer to commercial scale manufacturing. Verification confirms the achievement of instrument design specifications, which follows FDA Medical Device design control guidelines, to ensure the product was built correctly. Instrument verification means key performance aspects have been met, such as: hundreds of electrical and mechanical hardware design specifications, operation capabilities under a wide variety of operating conditions (temperature, humidity, noise and surface), and the safety specifications and compliance of a diagnostic device under Underwriters Laboratories guidelines. In addition to verification of the equipment, platform verification also achieves human diagnostic software requirements and standards, such as user workflow, user interface, and core controlling software.
The TRUFORMA™ diagnostic device and platform, which is smaller than a desktop printer, is anticipated to provide highly sensitive, species-specific initial assays for the diagnosis of thyroid disease in dogs and cats, and adrenal disease in dogs. Minimal clinic staff training is required to centrifuge the blood sample and dispense a small amount of serum (~100 μL) into the disposable assay cartridges which come preloaded with reagents.
在Truforma™平台上完成的第一个测定验证，在Qorvo的两种不同设施中在Qorvo上进行的，在700个样品上跨越700墨盒，是犬TT4测定。与当前行业标准犬TT4参考实验室测定相比，验证数据表明犬TT4的有希望的相关性和动态范围结果。如果在两种不同类型的机器上测试了相同的样本并达到完全相同的结果，则相关性将是r = 1。TRUFORMA™实现了r> 0.95的统计上显着的高相关性，即西门子Immulite®犬TT4测定（P值<0.0001）。动态范围是测试分析物的浓度可以以可接受的精度和精度测量的测试的功能范围。TRUFORMA™动态范围为0.45 - >30μg/ dL（与西门子免疫系列犬T4动态范围为0.5-15μg/ dL），这应该允许测量具有非常低的TT4水平（甲状腺功能率）和非常高的TT4的样品（甲状腺功能亢进）水平。
根据公司的独家开发和供应协议与Qorvo，实现这一里程碑的成就将要求公司为Qorvo提供300万美元。
TRUFORMA™TT4测定还将进行哺乳型应用的验证测试。剩余的四个上市甲状腺和肾上腺TRUFORMA™测定，正在进行额外的验证活动。验证测试中的测定项如下：犬类免费T4和犬和猫科（甲状腺刺激激素）。初始的两个肾上腺测定是：犬皮质醇和犬内源性ACTH（内源性肾上腺激素激素）。
在完成验证测试后，公司预计每次测定验证并启动专注于优化客户体验的并行试点计划。假设成功完成此核查和开发工作，Zomedica打算开始在选择战略市场中的所有五个初始测定的商业化。
As previously reported by the Company, the novel coronavirus, or COVID-19, pandemic has impacted the Company's expected timing for the completion of the development and the initiation of the commercialization of the TRUFORMA™ platform and the five initial assays. Once our development partner, validation participants and potential customers are able to return to normal operating procedures, we will assess the impact of the pandemic and update our expected timing accordingly.
Truforma™技术的灵活性提供稳定的潜在新产品发布和测试菜单扩展，超出甲状腺和肾上腺测试菜单，包括非传染性GI测定，新型肾和糖尿病标记，免疫测定，分子测定，全血样品，在同一平台上复用。
“我们认为Truforma™的创新能力将成为我们在临床点关怀的临床兽医中向临床兽医带来参考实验室测试能力的重要一步，”斯蒂芬妮莫利，Zomedica总裁。“我们认为Truforma™平台有可能将公司作为兽医动物伴侣动物诊断测试的领导者。”
关于Zomedica.
位于Zomedica（纽约美国美国人：Zom）的密歇根州安娜堡（纽约美国：Zom）是一家兽医诊断公司，通过专注于临床兽医的未满足需求，为伴侣动物（犬，猫和禽类）创造产品。Zomedica的产品组合将包括新型诊断和创新治疗方法，强调患者健康和实践健康。通过一个包括临床兽医专业人士的团队，Zomedica的使命使兽医有机会降低成本，提高生产力和增长收入，同时更好地为动物提供服务。有关更多信息，请访问www.ZOMEDICA.com.
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关于Qorvo Biotechnologies.
Qorvo Biotechnologies，LLC是Qorvo，Inc。的全资子公司（纳斯达克：QRVO），该子公司正在开发基于Qorvo的散装声波（BAW）滤波技术的传感器应用的护理点（POC）诊断系统。
前瞻性陈述
除了历史事实的陈述外，该新闻发布会包含某些“前瞻性信息”或“前瞻性陈述”（统称，“前瞻性信息”）在适用证券法的含义中。前瞻性信息经常以“计划”，“期望”，“项目”，“打算”，“预期”，“估计”和其他类似词语，或某些事件或条件的陈述"may" or "will" occur and include statements relating to Zomedica’s expectations regarding the public offering. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.
前瞻性信息基于对陈述的陈述日期管理的意见和估算，并受到各种风险和不确定性以及可能导致实际事件或结果的其他因素，以便与前方预期的那些有关看信息。可能导致结果与前瞻性信息中表达的结果不同的一些风险和其他因素包括但不限于：不确定我们的策略和商业计划是否会产生预期的福利;对发展工作和试点和关键研究的时序和结果，对监管批准，资本供应和成本的可能性和时间的不确定性;能够识别和开发和实现新产品和技术的商业成功;兽医接受我们的产品;相关产品的竞争;保持和提高产品质量所需的支出水平;技术的变化和法律法规的变化;我们能够确保和维持战略关系;风险与许可证和许可，知识产权侵权风险，与未来临床试验有关的风险，监管批准，我们产品的安全性和疗效，我们的产品使用，知识产权保护，与Covid-19大流行相关的风险及其影响 upon Zomedica's business operations generally, including Zomedica's ability to develop its diagnostic products, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR at www.sedar.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.
本新闻发布中包含的前瞻性信息由此警告声明明确限定。我们不承担更新任何前瞻性信息，以符合实际结果或更改我们的预期，除非适用证券立法另有要求。读者警告说明不会依赖于前瞻性信息。
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