Regulatory Milestone Designed to Expedite Path to FDA Clearance and CMS Coverage

旨在加快FDA批准和CMS覆盖范围的监管里程碑

SUNNYVALE, Calif., Nov. 28, 2023 /PRNewswire/ -- Inflammatix, Inc., a pioneering molecular diagnostics company, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company's lead product, the TriVerity™ Acute Infection and Sepsis Test System.

加利福尼亚州桑尼维尔，2023年11月28日/PRNewswire/-Inflammatix，Inc.，一家开创性的分子诊断公司，今天宣布美国食品和药物管理局（FDA）已授予该公司领先产品TriVerity的突破性设备名称™ 急性感染和败血症检测系统。

The TriVerity Test System, currently under development, includes the Myrna™ Instrument and the TriVerity Test and is intended to be used in emergency departments in adult patients with suspected acute infection or suspected sepsis. The TriVerity Test is designed to provide three independent readouts that reflect the likelihood of a bacterial infection, the likelihood of a viral infection, and the risk of severe illness (based on the need for critical organ support* within seven days of presentation to the emergency department)..

目前正在开发的TriVerity测试系统包括Myrna™ 仪器和TriVerity测试，旨在用于疑似急性感染或疑似败血症的成人患者的急诊科。TriVerity测试旨在提供三个独立的读数，反映细菌感染的可能性，病毒感染的可能性以及严重疾病的风险（基于在向紧急情况介绍后七天内对关键器官支持的需求）部门）。。

'We are pleased that the FDA has granted its Breakthrough Device Designation to TriVerity, as it reflects that this novel test system has the potential to help physicians improve on the current standard of care,' said Dr. Timothy Sweeney, CEO and co-founder of Inflammatix. 'By reaching this important regulatory milestone, we hope to place TriVerity on an accelerated pathway to FDA clearance, which would allow us to fill an unmet need for rapid, accurate tests for the diagnosis and prognosis of patients with suspected sepsis.'.

“我们很高兴FDA已将其突破性设备名称授予TriVerity，因为它反映了这种新型测试系统有可能帮助医生改进当前的护理标准，”Timothy Sweeney博士，首席执行官兼共同创始人Inflammatix'通过达到这一重要的监管里程碑，我们希望将三位一体放在FDA批准的加速途径上，这将使我们能够满足对疑似败血症患者的诊断和预后进行快速，准确测试的未满足需求。

The FDA established the Breakthrough Devices Program as a voluntary mechanism for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval and marketing authorization..

FDA将突破性设备计划确立为某些医疗设备和设备主导的组合产品的自愿机制，为更有效地治疗或诊断威胁生命或不可逆转地使人衰弱的疾病或病症提供服务。该计划旨在通过加速开发，评估和审查上市前批准和上市许可，为患者和医疗保健提供者提供及时使用医疗器械的机会。。

As a Breakthrough Device, TriVerity is expected to be eligible for the Centers for Medicare & Medicaid Services (CMS) New Technology Add-On Payment (NTAP) program, which will enable future Inflammatix hospital customers to receive a partial subsidy for purchases of TriVerity Acute Infection and Sepsis Tests performed on admitted patients for up to three years.

作为一项突破性设备，TriVerity有望获得医疗保险和医疗补助服务中心（CMS）新技术附加支付（NTAP）计划的资格，这将使未来的Inflammatix医院客户能够获得部分补贴，以购买TriVerity急性对入院患者进行感染和败血症测试长达三年。

In addition, assuming CMS finalizes its proposed Temporary Coverage for Emerging Technologies (TCET) rule, the TriVerity Test may be eligible for temporary coverage for tests run on discharged Medicare patients for up to four years. CMS is expected to issue its final ruling on TCET in December 2023..

此外，假设CMS最终确定其拟议的新兴技术临时覆盖（TCET）规则，那么TriVerity测试可能有资格对出院的Medicare患者进行长达四年的测试的临时覆盖。预计CMS将于2023年12月发布关于TCET的最终裁决。。

'The potential Medicare reimbursement benefits associated with Breakthrough Designation may expedite implementation of TriVerity in our partner hospitals,' commented Dr. Sweeney. 'We continue to engage with payers, hospitals, and other stakeholders on our path to commercial launch.'

Sweeney博士评论说：“与突破性指定相关的潜在医疗保险报销福利可能会加快我们合作医院TriVerity的实施。”我们继续与付款人，医院和其他利益相关者合作，共同实现商业发布

* Defined as the need for mechanical ventilation, vasopressors, or renal replacement therapy.

*定义为需要机械通气，血管加压药或肾脏替代疗法。

About the TriVerity Acute Infection and Sepsis Test System

关于TriVerity急性感染和败血症检测系统

The TriVerity™ Acute Infection and Sepsis Test System, the lead product for Inflammatix, includes the Myrna™ Instrument and the TriVerity Test. The TriVerity Test incorporates a panel of 29 messenger RNAs (mRNAs) to 'read' the body's immune response, providing three readouts to facilitate diagnosis and prognosis of adult patients with suspected acute infection or sepsis that present in US emergency departments.

三位一体™ 急性感染和败血症测试系统是Inflammatix的主要产品，包括Myrna™ 仪器和TriVerity测试。TriVerity测试结合了一组29个信使RNA（mRNA）来“读取”人体的免疫反应，提供三个读数，以促进美国急诊科疑似急性感染或败血症的成年患者的诊断和预后。

Based on internal analysis of the Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP) database, Inflammatix estimates roughly 20 million patients per year visit emergency departments with symptoms consistent with suspected acute infection..

根据医疗保健研究和质量机构（AHRQ）医疗保健成本和利用项目（HCUP）数据库的内部分析，Inflammatix估计每年约有2000万患者访问急诊科，其症状与疑似急性感染一致。。

The Myrna Instrument is capable of sample-to-answer quantitation of up to 64 mRNAs from whole blood or other sample types in about 30 minutes. While the first version of the Myrna Instrument will require standard laboratory operation, the company's roadmap includes the development of a Clinical Laboratory Improvement Amendments (CLIA)-waivable version to enable point-of-care deployments..

Myrna仪器能够在约30分钟内从全血或其他样品类型中对多达64种mRNA进行样品到答案的定量。虽然Myrna仪器的第一版需要标准的实验室操作，但公司的路线图包括开发临床实验室改进修正案（CLIA）-可撤销版本，以实现即时部署。。

The company recently announced the completion of technical development for the TriVerity Test System and has resumed its clinical studies, including its SEPSIS-SHIELD study (NCT04094818) required for 510(k) clearance of the TriVerity Test System by the FDA. The multi-center study has already enrolled 955 of the estimated 1,500 patients targeted.

该公司最近宣布完成TriVerity测试系统的技术开发，并已恢复其临床研究，包括FDA 510（k）清除TriVerity测试系统所需的SEPSIS-SHIELD研究（NCT04094818）。多中心研究已经招募了约1500名目标患者中的955名。

The company estimates study completion and FDA submission to occur in 2024..

该公司估计研究完成和FDA提交将于2024年进行。。

The TriVerity Acute Infection and Sepsis Test System is a product in development, is not for sale, and does not have marketing approval or clearance from regulatory authorities in any jurisdiction.

TriVerity急性感染和败血症检测系统是一种正在开发的产品，不销售，并且没有任何辖区的监管机构的市场批准或许可。

About Inflammatix

关于Inflammatix

Inflammatix, Inc., a pioneering molecular diagnostics company headquartered in Sunnyvale, California, USA, is developing novel diagnostics that rapidly read a patient's immune system to improve patient care and reduce major public health burdens. The Inflammatix tests will be developed to run on the company's sample-to-answer isothermal instrument platform, enabling the power of precision medicine at the point of care.

Inflammatix，Inc.是一家总部设在美国加利福尼亚州桑尼维尔的开创性分子诊断公司，正在开发新型诊断技术，可快速读取患者的免疫系统，改善患者护理并减轻重大公共卫生负担。Inflammatix测试将开发用于在公司的样品回答等温仪器平台上运行，从而在护理点实现精准医学的力量。

The company's funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, D1 Capital, and the Stanford-StartX Fund. For more information, please visit www.inflammatix.com and follow the company on LinkedIn and X (formerly Twitter) at @Inflammatix_Inc)..

该公司的资助者包括Khosla Ventures，Northpond Ventures，Think。Health Ventures，D1 Capital和Stanford StartX基金。欲了解更多信息，请访问www.inflammatix.com，并通过LinkedIn和X（以前的Twitter）在@inflammatix_Inc上关注该公司。。

Inflammatix product development has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract Nos. 75A50119C00034 and 75A50119C00044..

Inflammatix产品开发的部分资金来自卫生和公众服务部的联邦资金；准备和响应助理秘书办公室；生物医学高级研究与开发局，合同号75A50119C00034和75A50119C00044。。

TriVerity, Myrna, and Inflammatix are trademarks of Inflammatix, Inc. in the US and other countries and regions.

TriVerity，Myrna和Inflammatix是Inflammatix，Inc。在美国和其他国家和地区的商标。

SOURCE Inflammatix

源Inflammatix