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
Combination Test Also Secures Point-Of-Care Authorization in Australia
組合測試還可在澳大利亞獲得護理點授權
Lucira COVID-19 & Flu Home Test – The First & Only Combination Test for OTC Use At Home
Lucira COVID-19 和流感家庭測試-第一個和唯一的家庭場外交易使用的組合測試
Lucira COVID-19 & Flu Home Test – All You Need to Answer "Is it Covid or the Flu?"
盧西拉 COVID-19 和流感家庭測試 — 所有你需要回答「是 Covid 還是流感?」
Lucira COVID-19 & Flu Home Test – The First OTC Test to Diagnose Flu at Home in History
Lucira COVID-19 和流感家庭測試-歷史上第一個在家中診斷流感的非處方測試
- 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
- COVID-19 和流感的實驗室質量結果現在可在家中通過一次 test 獲得
- COVID-19 和流感有類似的症狀,但治療方法不同,需要快速的差異 test 才能獲得時間敏感的處方治療選項
- Lucira 的 COVID-19 和流感家庭測試在頭對頭比較研究中,通過高度敏感的實驗室 PCR 測試,證明 COVID-19 和流感的表現相似
- Lucira 還在南半球流感季節之前在澳大利亞獲得了護理點 test(POCT)授權
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 .
加利福尼亞州埃默里維爾,2023 年 3 月 28 日(全球美通社)-盧西拉健康有限公司(「盧西拉健康」或「盧西拉」)今天宣布在美國全國推出其突破性的 Lucira COVID-19 和流感家庭測試,以及聯合測試被列入澳大利亞治療專業人員註冊(ARTG)的治療用品註冊(ARTG)照護點設定。COVID-19 和流感家居 test 是美國食品藥物管理局(FDA)第一個也是唯一一個組合 COVID-19 和流感檢測獲得緊急使用授權(EUA),可在家中和其他非實驗室場所進行非處方(OTC)使用。Lucira COVID-19 和流感家庭 test 是一種分子測試,與臨床試驗中基於實驗室的高敏感性 PCR 測試相比,COVID-19 和流感的性能相似。易於使用的多合一組合 test 可通過一個淺鼻拭子在 30 分鐘或更短的時間內提供結果,截至今天,可以在美國以 34.99 美元的入門價格購買。
"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 總裁兼執行長 Erik Engelson 表示:「這兩項成就都代表了 Lucira 的重要里程碑,並強調了 Lucira 技術平台在全球居家和照護點照護環境中的可行性。「美國消費者將有史以來第一次能夠診斷他們在家中是否患有 COVID-19 或 A 型或 B 型流感。透過我們的 Lucira Connect 網路平台一鍵式存取遠距醫療,他們現在可以在舒適的家中接收 test 結果後數小時內進入治療和恢復的道路。」
"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."
「我們同樣高興將 COVID-19 和流感測試納入澳大利亞治療產品登記冊。當流感季節在美國靜止時,流感季節通常會在南半球出現。我們相信,通過我們的聯合 test 診斷的速度和準確性可以幫助患者在澳大利亞快速獲得治療和康復。當我們尋求戰略或財務合作夥伴以恢復生產和開發其他家庭診斷產品時,這些授權證明了 Lucira 產品的未來和臨床相關性。」
For more information on the Lucira COVID-19 & Flu Home Test, please visit .
有關 Lucira COVID-19 和流感家居測試的更多信息,請訪問。
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.
關於露西拉 COVID-19 和流感家庭測試
露西拉 COVID-19 和流感家庭 test 不是抗原測試。這是一種分子核酸放大(NAAT)test,利用與 Lucira 商業化 FDA 授權的 COVID-19 test 相同的平台和設備設計,為 COVID-19,A 型流感和流感 B 提供獨立診斷。實驗室質量的一次性測試適合您的手掌,使用 2 節 AA 電池,並使用一個淺鼻拭子為 COVID-19 流感提供陽性或陰性結果,為流感 A 提供陽性或陰性結果少。每個 Lucira test 都包含運行單個 test 所需的所有內容。沒有單獨的閱讀器或儀器購買和維護。
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 .
關於露西拉健康
Lucira 是一家專注於創新傳染病測試的開發和商業化的醫療技術公司,以使實驗室質量的診斷更容易獲得。Lucira 設計的 test 平台可隨時隨地提供準確、可靠、實驗室品質的 test 結果。除了已經商業化的 COVID-19 和 COVID-19 和流感測試之外,Lucira 還在研究針對呼吸道感染和其他類別的新診斷測試,包括婦女的健康和性傳播感染(STI)。如需詳細資訊,請造訪。
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.
前瞻性陳述
本新聞稿中包含有關非歷史事實的事項的聲明是 1995 年《私人證券訴訟改革法》所指的「前瞻性陳述」。由於該等陳述受風險及不明朗因素所影響,因此實際結果可能與該等前瞻性陳述所明示或暗示的結果有重大差異。諸如「CAN」,「意志」,「尋求」,「相信」,「計劃」和類似的詞語旨在識別前瞻性陳述。這些前瞻性陳述,包括但不限於美國消費者在家中診斷 COVID-19 和 A 型流感或 B 型流感的能力,並在接收 test 結果後的幾個小時內走上治療和恢復;Lucira COVID-19 和流感家庭測試可以幫助患者快速獲得治療或在澳大利亞尋求治療和康復的能力;Lucira 和流感家庭測試可以幫助患者快速獲得治療和康復;Lucira 和流感家庭測試可以幫助患者快速獲得治療和康復;Lucira 和流感家庭測試具有幫助患者快速獲得治療或康復的能力;金融合作夥伴的恢復製造和額外的家庭的發展診斷產品;以及 Lucira 針對呼吸道感染、女性健康和性病的新診斷測試的研究,均基於 Lucira 目前的預期,並涉及可能永遠不會實現或可能證明不正確的假設。由於各種風險和不確定性,實際結果可能與此類前瞻性陳述中預期的結果有很大不同。我們在本公告中作出的任何前瞻性聲明僅在本新聞稿發布日期起發言,除非適用法律要求,否則我們沒有義務更新前瞻性聲明,無論是由於新信息,未來事件還是在本新聞稿發布日期之後的其他原因。
Media Contact:
media@lucirahealth.com
媒體聯絡人:
media@lucirahealth.com
Photos accompanying this announcement are available at
隨附此公告的照片可在