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.
周二，QuideLortho Corporation（纳斯达克股票代码：QDEL）的QuickVue COVID-19 测试获得了美国食品药品管理局510（k）的许可。
This clearance allows the test to be used accurately and conveniently in home and medical facility settings with CLIA certificates of waiver.
该许可允许在带有CLIA豁免证书的家庭和医疗机构环境中准确、方便地使用该测试。
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 测试专为症状发作后六天内出现症状的个体而设计，经批准适用于 14 岁及以上的人进行自我检测，以及由成人给药时的 2 岁及以上人群。
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 聚合酶链反应平台和 Savanna HSV 1+2/VZV 聚合酶链反应检测获得了 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.
该许可授权向进行中度或高复杂度诊断测试的美国实验室销售和销售稀树草原多重分子平台和稀树草原HSV 1+2/VZV检测。
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，该股正在暴跌，因为该公司表示，在审查了大草原RVP4+（呼吸道病毒Panel-4）检测的表现后，决定撤回美国食品药品管理局目前提交的Savanna RVP4+分析的510（k）报告。
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).
稀树草原RVP4测定旨在与稀树草原仪器一起使用，用于同时对甲型流感、乙型流感、呼吸道合胞病毒和SARS-CoV-2（COVID-19）进行定性检测和区分。
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.
该检测所针对的四种病毒在9个月内生成的数据最初显示出良好的前景，导致FDA于2023年7月提交了报告。但是，2024年2月提交的最终数据集没有达到预期。
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，在提交待定期间，该公司继续开发下一代RVP4+检测。该公司预计，新的多重检测将在2024/2025年呼吸季节上市。
The company expects to begin clinical trials for its sexually transmitted infection panel later in the second quarter.
该公司预计将在第二季度晚些时候开始其性传播感染小组的临床试验。
RBC Capital Markets writes that despite the news, there has been no change in the price target of $81 and the Outperform rating.
加拿大皇家银行资本市场写道，尽管有这个消息，但81美元的目标股价和跑赢大盘的评级没有变化。
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.
加拿大皇家银行表示已与管理层进行了接触，他们表示一直在并行努力解决前一次小组讨论中出现的问题。
The company also mentioned no updates to Savanna's 2024 guidance of $30 million – $50 million, with dilutive EBITDA margins.
该公司还提到，Savanna2024年的3000万至5000万美元预期没有更新，息税折旧摊薄后的息税折旧摊销前利润率。
Price Action: QDEL shares are down 10.6% at $42 on the last check Tuesday.
价格走势：在周二的最后一次支票中，QDEL股价下跌10.6％，至42美元。
Photo via Shutterstock
照片来自 Shutterstock
译文内容由第三方软件翻译。