NEW YORK – Qiagen announced Tuesday that the US Food and Drug Administration has cleared the company’s QiaStat-Dx Respiratory Panel Mini syndromic multiplex qPCR test.

纽约–Qiagen周二宣布，美国食品和药物管理局已批准该公司的QiaStat Dx呼吸面板微型综合征多重qPCR检测。

The regulatory decision marks the third assay clearance for the QiaStat-Dx system in 2024, Qiagen said in a statement.

Qiagen在一份声明中说，监管决定标志着2024年QiaStat Dx系统的第三次检测许可。

The mini panel detects five respiratory pathogens considered to be the most actionable in outpatient settings. Specifically, it targets influenza A, influenza B, human rhinovirus, respiratory syncytial virus, and SARS-CoV-2.

该迷你小组检测到五种呼吸道病原体，这些病原体被认为是门诊环境中最可行的。具体而言，它针对甲型流感，乙型流感，人鼻病毒，呼吸道合胞病毒和SARS-CoV-2。

The QiaStat-Dx system provides results in approximately one hour, requiring roughly one minute of hands-on time. It also displays cycle threshold values and amplification curves on the instrument touchscreen.

QiaStat Dx系统大约在一小时内提供结果，需要大约一分钟的动手时间。它还在仪器触摸屏上显示循环阈值和放大曲线。

Qiagen previously obtained regulatory authorization for its 21-target Respiratory Panel Plus on the QiaStat-Dx, which the firm said is appropriate for hospitalized patients with risk factors for severe disease.

Qiagen之前在QiaStat Dx上获得了21 target Respiratory Panel Plus的监管授权，该公司表示，该产品适用于有严重疾病危险因素的住院患者。

Nadia Aelbrecht, VP and head of the syndromic testing franchise at Qiagen, said in the statement that the two panels 'will improve diagnostic stewardship by enabling clinicians to tailor testing to each patient's unique needs, choosing between a full, comprehensive panel or a more targeted one.'

Qiagen综合征检测专营权副总裁兼主管NadiaAelbrecht在声明中表示，这两个小组“将通过使临床医生能够根据每位患者的独特需求量身定制检测，从而改善诊断管理，可以在全面的综合小组或更有针对性的小组之间进行选择。”

In addition, Aelbrecht said, 'By streamlining the diagnostic process and delivering accurate results in about an hour for both outpatient and inpatient groups, these tests will enhance patient care, promote responsible antimicrobial stewardship, and alleviate the strain on healthcare systems.'

此外，Aelbrecht说，“通过简化诊断过程并在大约一小时内为门诊和住院患者群体提供准确的结果，这些测试将加强患者护理，促进负责任的抗菌药物管理，并减轻医疗保健系统的压力。”

A five-target mini panel from BioMérieux was cleared and CLIA waived last year, with the rhinovirus target in the mini panel added to increase diagnostic yield. That firm also recently obtained clearance and CLIA waiver for a sore throat mini panel.

去年，BioMe rieux的一个五目标迷你小组被清除，CLIA放弃了，迷你小组中的鼻病毒目标被增加，以提高诊断率。该公司最近还获得了喉咙痛迷你小组的批准和CLIA豁免。

Qiagen, meanwhile, recently launched the QiaStat-Dx 2.0 for use with the Respiratory Panel Plus and the Gastrointestinal Panel 2, while an extension for use with the Respiratory Panel Mini is planned. The upgraded system allows users to view, comment on, and confirm diagnostic test results directly from their desktop and mobile devices.

升级后的系统允许用户直接从桌面和移动设备查看、评论和确认诊断测试结果。

The higher-capacity QiaStat-Dx Rise is CE-IVD marked with a planned submission to the FDA in 2025..

更高容量的QiaStat Dx上升是CE-IVD，计划于2025年提交给FDA。

The firm has also obtained FDA clearance for its Gastrointestinal Panel 2, submitted its Meningitis/Encephalitis Panel, and plans to submit its Gastrointestinal Panel Mini to the FDA by the end of this year, Qiagen said.

Qiagen说，该公司还获得了FDA对其胃肠道面板2的批准，提交了脑膜炎/脑炎面板，并计划在今年年底之前将其胃肠道面板迷你版提交给FDA。

Qiagen has previously said it aims to double its QiaStat-Dx syndromic testing business from roughly $100 million in annual sales in 2023 to $200 million in 2028.

Qiagen此前表示，其目标是将其QiaStat Dx综合征检测业务从2023年的年销售额约1亿美元增加到2028年的2亿美元。