What's Going With COVID-19 Test Maker QuidelOrtho Stock On Tuesday?
What's Going With COVID-19 Test Maker QuidelOrtho Stock On Tuesday?
On Tuesday, QuidelOrtho Corporation (NASDAQ:QDEL) received FDA 510(k) clearance for its QuickVue COVID-19 test.
週二，QuideLortho Corporation（納斯達克股票代碼：QDEL）的QuickVue COVID-19 測試獲得了美國食品藥品管理局510（k）的許可。
This clearance allows the test to be used accurately and conveniently in home and medical facility settings with CLIA certificates of waiver.
該許可允許在帶有CLIA豁免證書的家庭和醫療機構環境中準確、方便地使用該測試。
The QuickVue COVID-19 test, designed for symptomatic individuals within six days of symptom onset, is cleared for use in individuals aged 14 or older when self-testing and in those aged two and older when administered by an adult.
QuickVue COVID-19 測試專爲症狀發作後六天內出現症狀的個體而設計，經批准適用於 14 歲及以上的人進行自我檢測，以及由成人給藥時的 2 歲及以上人群。
QuidelOrtho secured FDA 510(k) clearance in December 2023 for its Savanna PCR platform and Savanna HSV 1+2/VZV PCR assay.
2023 年 12 月，QuideLortho 的 Savanna 聚合酶鏈反應平台和 Savanna HSV 1+2/VZV 聚合酶鏈反應檢測獲得了 FDA 510 (k) 的批准。
This clearance authorizes the marketing and sale of the Savanna multiplex molecular platform and the Savanna HSV 1+2/VZV assay to U.S. laboratories conducting moderate or high-complexity diagnostic testing.
該許可授權向進行中度或高複雜度診斷測試的美國實驗室銷售和銷售稀樹草原多重分子平台和稀樹草原HSV 1+2/VZV檢測。
However, the shares are plunging as the company said that upon reviewing the performance of the Savanna RVP4+ (Respiratory Viral Panel-4) assay against the clinical market's expectations, a decision was made to withdraw the current FDA 510(k) submission for the Savanna RVP4+ assay.
但是，該股正在暴跌，因爲該公司表示，在審查了大草原RVP4+（呼吸道病毒Panel-4）檢測的表現後，決定撤回美國食品藥品管理局目前提交的Savanna RVP4+分析的510（k）報告。
The Savanna RVP4 Assay is intended for use with the Savanna instrument for the simultaneous qualitative detection and differentiation of influenza A, influenza B, respiratory syncytial virus, and SARS-CoV-2 (COVID-19).
稀樹草原RVP4測定旨在與稀樹草原儀器一起使用，用於同時對甲型流感、乙型流感、呼吸道合胞病毒和SARS-CoV-2（COVID-19）進行定性檢測和區分。
Data generated over a 9-month for the four viruses targeted by the assay initially showed great promise, leading to the FDA submission in July 2023. However, the final dataset, submitted in February 2024, did not meet expectations.
該檢測所針對的四種病毒在9個月內生成的數據最初顯示出良好的前景，導致FDA於2023年7月提交了報告。但是，2024年2月提交的最終數據集沒有達到預期。
In addition, during the pendency of the submission, the company has continued to develop the next-generation RVP4+ assay. The company anticipates the new multiplex assay to be commercially available during the 2024/2025 respiratory season.
此外，在提交待定期間，該公司繼續開發下一代RVP4+檢測。該公司預計，新的多重檢測將在2024/2025年呼吸季節上市。
The company expects to begin clinical trials for its sexually transmitted infection panel later in the second quarter.
該公司預計將在第二季度晚些時候開始其性傳播感染小組的臨床試驗。
RBC Capital Markets writes that despite the news, there has been no change in the price target of $81 and the Outperform rating.
加拿大皇家銀行資本市場寫道，儘管有這個消息，但81美元的目標股價和跑贏大盤的評級沒有變化。
RBC said it reached out to management, and they said that they have been working in parallel to address issues seen in the prior panel.
加拿大皇家銀行表示已與管理層進行了接觸，他們表示一直在並行努力解決前一次小組討論中出現的問題。
The company also mentioned no updates to Savanna's 2024 guidance of $30 million – $50 million, with dilutive EBITDA margins.
該公司還提到，Savanna2024年的3000萬至5000萬美元預期沒有更新，息稅折舊攤薄後的息稅折舊攤銷前利潤率。
Price Action: QDEL shares are down 10.6% at $42 on the last check Tuesday.
價格走勢：在週二的最後一次支票中，QDEL股價下跌10.6％，至42美元。
Photo via Shutterstock
照片來自 Shutterstock
譯文內容由第三人軟體翻譯。