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Lucira Health Announces U.S. Launch of First & Only At-Home Combination COVID-19 & Flu Test Amidst Sale Process

Lucira Health Announces U.S. Launch of First & Only At-Home Combination COVID-19 & Flu Test Amidst Sale Process

Lucira Health 宣布在销售过程中在美国推出首款也是唯一一款在家使用 COVID-19 和流感的联合检测
GlobeNewswire ·  2023/03/28 08:12

Combination Test Also Secures Point-Of-Care Authorization in Australia

组合测试还确保了澳大利亚的即时医疗授权

Lucira COVID-19 & Flu Home Test – The First & Only Combination Test for OTC Use At Home

Lucira COVID-19 和流感家庭测试 — 首次也是唯一一次在家中使用非处方药的组合测试

Is it Covid, or the Flu? It can be hard to tell which virus you have based on symptoms alone, but you need to know to get the right treatment. Now, with the Lucira COVID-19 & Flu Home Test, Americans can for the first time accurately self-diagnose whether it is Covid or the Flu with molecular level accuracy in 30 minutes or less at home. Now available at lucirahealth.com.
是Covid还是流感?仅凭症状可能很难分辨出你感染了哪种病毒,但你需要知道才能得到正确的治疗。现在,通过 Lucira COVID-19 和流感家庭测试,美国人首次可以在家中 30 分钟或更短的时间内以分子水平准确地自我诊断出是 Covid 还是流感。现已在 lucirahealth.com 上市

Lucira COVID-19 & Flu Home Test – All You Need to Answer "Is it Covid or the Flu?"

Lucira COVID-19 和流感家庭测试 — 你只需要回答 “是 Covid 还是流感?”

Flu and Covid continue to co-circulate, and it can be hard to tell which virus you have based on symptoms alone. The Lucira COVID-19 & Flu Home Test has everything you need to accurately diagnose whether it is Covid or the Flu in 30 minutes or less in the comfort of your home. Now available at lucirahealth.com.
流感和Covid继续共同传播,仅凭症状可能很难分辨出你感染了哪种病毒。Lucira COVID-19 和流感家庭测试包含了您在家中舒适地在 30 分钟或更短的时间内准确诊断出是 Covid 还是流感所需的一切。现已在 lucirahealth.com 上市

Lucira COVID-19 & Flu Home Test – The First OTC Test to Diagnose Flu at Home in History

Lucira COVID-19 和流感家庭测试——历史上第一款在家诊断流感的非处方药测试

Americans have never before been able to accurately self-diagnose Flu at-home, until today. The Lucira COVID-19 & Flu Home Test is the only combination test to diagnose Covid and Flu at home, and is the first at-home test to ever allow self-diagnosis of Flu. Now you can tell whether it is Covid or the Flu with molecular level accuracy in 30 minutes or less at home. Now available at lucirahealth.com.
直到今天,美国人还从未能够在家中准确地自我诊断流感。Lucira COVID-19 和流感家庭测试是唯一一种在家中诊断 Covid 和流感的组合测试,也是有史以来第一个允许自我诊断流感的居家测试。现在,你可以在家里 30 分钟或更短的时间内以分子水平的准确度分辨出是 Covid 还是流感。现已在 lucirahealth.com 上市
  • Lab-quality results for both COVID-19 and Flu now available at home from one single test
  • COVID-19 and Flu have similar symptoms but different treatments, requiring a fast, differential test to access time-sensitive prescription treatment options
  • Lucira's COVID-19 & Flu Home Test demonstrated similar performance for COVID-19 and Flu in head-to-head comparison study with highly sensitive lab-based PCR tests
  • Lucira also secured point-of-care test (POCT) authorization in Australia prior to southern hemisphere flu season
  • 现在,只需一次测试,即可在家中获得 COVID-19 和流感的实验室质量结果
  • COVID-19 和流感的症状相似,但治疗方法不同,需要进行快速的差异化测试才能获得时间敏感的处方治疗方案
  • Lucira 的 COVID-19 和流感家庭测试在与基于高度灵敏的实验室聚合酶链反应测试的正面对比研究中显示 COVID-19 和流感的表现相似
  • 在南半球流感季节之前,Lucira还在澳大利亚获得了即时检测(POCT)的授权

EMERYVILLE, Calif., March 28, 2023 (GLOBE NEWSWIRE) -- Lucira Health, Inc. ("Lucira Health" or "Lucira"), a medical technology company, announced today both the nationwide launch of its breakthrough Lucira COVID-19 & Flu Home Test in the United States, as well as the combination test's inclusion in the Australian Register of Therapeutic Goods (ARTG) for use by healthcare professionals in a point-of-care setting. The COVID-19 & Flu Home Test is the first and only combination COVID-19 & Flu test to be granted emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) for over the counter (OTC) use at home and other non-laboratory sites. The Lucira COVID-19 & Flu Home Test is a molecular test that demonstrated similar performance for COVID-19 and Influenza compared to highly sensitive lab-based PCR tests in clinical trials. The easy-to-use, all-in-one combination test delivers results in 30 minutes or less from one shallow nasal swab, and as of today can be purchased in the United States for the introductory price of $34.99 at .

加利福尼亚州埃默里维尔,2023年3月28日(GLOBE NEWSWIRE)——医疗技术公司Lucira Health, Inc.(“Lucira Health” 或 “Lucira”)今天宣布,将在全国范围内推出其突破性的Lucira COVID-19 和流感家庭测试,并将该组合测试纳入澳大利亚治疗用品登记册(ARTG),供医疗保健专业人员在治疗用品登记册(ARTG)中使用即时医疗设置。COVID-19 和流感家庭测试是第一项也是唯一一项获得美国食品药品监督管理局 (FDA) 紧急使用授权 (EUA) 的 COVID-19 和流感联合检测,可在家庭和其他非实验室场所进行非处方药 (OTC) 使用。Lucira COVID-19 和流感家庭测试是一项分子测试,与临床试验中基于实验室的高灵敏度聚合酶链反应测试相比,其对 COVID-19 和流感的性能相似。这种易于使用的多合一组合测试可在30分钟或更短的时间内从一个浅鼻拭子中获得结果,并且从今天起可以在美国购买,入门价格为34.99美元。

"Both of these accomplishments represent important milestones for Lucira and underscore the viability of the Lucira technology platform in both at-home and point-of-care settings around the globe," said Erik Engelson, President and CEO of Lucira Health. "U.S. consumers will, for the first time ever, be able to diagnose if they have COVID-19 or Flu A or B while at home. With one-touch access to telehealth via our Lucira Connect web platform, they can now get onto the path to treatment and recovery within hours of receiving a test result from the comfort of home."

Lucira Health总裁兼首席执行官埃里克·恩格尔森表示:“这两项成就对Lucira来说都是重要的里程碑,也凸显了Lucira技术平台在全球居家和即时医疗环境中的可行性。”“美国消费者将有史以来第一次能够在家中诊断出他们是否患有 COVID-19、甲型或乙型流感。通过我们的 Lucira Connect 网络平台一键访问远程医疗,他们现在可以在家中舒适地收到测试结果后的几个小时内走上治疗和康复之路。”

"We are equally pleased to have our COVID-19 & Flu Test be included in the Australian Register of Therapeutic Goods. When flu season quiets down in the United States, it typically picks up in the southern hemisphere, and we believe that the speed and accuracy of diagnosis from our combination test could help patients to quickly access treatment and recovery in Australia. These authorizations speak to the future and clinical relevance of Lucira products as we seek a strategic or financial partner for the resumption of manufacturing and development of additional home diagnostic products."

“我们同样很高兴我们的 COVID-19 和流感测试被纳入澳大利亚治疗用品登记册。当美国的流感季节平静下来时,南半球通常会回升,我们相信,我们的联合测试得出的诊断速度和准确性可以帮助患者在澳大利亚快速获得治疗和康复。这些授权说明了Lucira产品的未来和临床意义,因为我们正在寻找战略或财务合作伙伴,以恢复其他家庭诊断产品的生产和开发。”

For more information on the Lucira COVID-19 & Flu Home Test, please visit .

有关 Lucira COVID-19 和流感家庭测试的更多信息,请访问。

About the Lucira COVID-19 & Flu Home Test
The Lucira COVID-19 & Flu Home Test is not an antigen test. It is a molecular, nucleic acid amplification (NAAT) test that utilizes the same platform and device design as both of Lucira's commercialized FDA authorized COVID-19 tests to provide independent diagnoses for COVID-19, Flu A and Flu B. The lab-quality single-use test fits in the palm of your hand, runs on 2 AA batteries, and with one shallow nasal swab provides a positive or negative result for COVID-19, Flu A and Flu B in 30 minutes or less. Each Lucira test contains everything needed to run a single test. There is no separate reader or instrument to purchase and maintain.

关于 Lucira COVID-19 和流感家庭测试
Lucira COVID-19 和流感家庭测试不是抗原测试。这是一种分子核酸扩增 (NAAT) 测试,其平台和设备设计与 Lucira 的两项商业化 FDA 授权的 COVID-19 测试相同,可为 COVID-19、A 型流感和 B 型流感提供独立诊断。实验室质量的一次性测试可放在您的手掌中,使用 2 节 AA 电池运行,使用一块浅鼻拭子可在 30 分钟或更短的时间内得出 COVID-19、A 型流感和乙型流感的阳性或阴性结果。每个 Lucira 测试都包含运行单个测试所需的所有内容。没有单独的读卡器或仪器可供购买和维护。

About Lucira Health
Lucira is a medical technology company focused on the development and commercialization of innovative infectious disease tests to make lab-quality diagnostics more accessible. Lucira designed its test platform to provide accurate, reliable, lab-quality test results anywhere and at any time. Beyond its already commercialized molecular COVID-19 and COVID-19 & Flu tests, Lucira is working on new diagnostic tests for respiratory infections and other categories including women's health and sexually transmitted infections (STIs). For more information, visit .

关于 Lucira Health
Lucira 是一家医疗技术公司,专注于创新传染病检测的开发和商业化,以使实验室质量的诊断更容易获得。Lucira 设计的测试平台可随时随地提供准确、可靠、实验室质量的测试结果。除了已经商业化的分子 COVID-19、COVID-19 和流感检测外,Lucira还在研究呼吸道感染和其他类别的新诊断测试,包括女性健康和性传播感染(STI)。欲了解更多信息,请访问。

Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "can," "will," "seek," "believe," "plans" and similar expressions are intended to identify forward-looking statements. These forward-looking statements, including but not limited to, the ability of U.S. consumers to diagnose COVID-19 and Flu A or B while at home and get on the path to treatment and recovery within hours of receiving a test result; flu season typically picking up in the southern hemisphere as it quiets down in the United States; the Lucira COVID-19 & Flu Home Test's ability to help patients quickly access treatment and recovery in Australia; Lucira's seeking a strategic or financial partner for the resumption of manufacturing and development of additional home diagnostic products; and Lucira's work on new diagnostic tests for respiratory infections, women's health and STIs, are based upon Lucira's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and we assume no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.

前瞻性陈述
本新闻稿中包含的关于非历史事实的事项的声明是1995年《私人证券诉讼改革法》所指的 “前瞻性陈述”。由于此类陈述受风险和不确定性的影响,因此实际结果可能与此类前瞻性陈述所表达或暗示的结果存在重大差异。诸如 “可以”、“将”、“寻求”、“相信”、“计划” 之类的词语以及类似的表达方式旨在识别前瞻性陈述。这些前瞻性陈述,包括但不限于美国消费者在家中诊断 COVID-19 和甲型或乙型流感,并在收到检测结果后的几小时内走上治疗和康复之路的能力;随着美国的平静下来,流感季节通常在南半球开始回升;Lucira COVID-19 和流感家庭测试帮助患者在澳大利亚快速获得治疗和康复的能力;Lucira 正在寻找战略或财务合作伙伴恢复制造和开发更多住房诊断产品;以及露西拉在呼吸道感染、女性健康和性传播感染的新诊断测试方面的工作,均基于露西拉目前的预期,涉及的假设可能永远无法实现或可能被证明是不正确的。由于各种风险和不确定性,实际结果可能与此类前瞻性陈述中的预期结果存在重大差异。我们在本公告中作出的任何前瞻性陈述仅代表截至本新闻稿发布之日,除非适用法律要求,否则我们没有义务更新前瞻性陈述,无论是由于新信息、未来事件还是本新闻稿发布之日以后的其他原因。

Media Contact:
media@lucirahealth.com

媒体联系人:
media@lucirahealth.com

Photos accompanying this announcement are available at

本公告附带的照片可在以下网址获得


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