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.
The regulatory decision marks the third assay clearance for the QiaStat-Dx system in 2024, Qiagen said in a statement.
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.
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.
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.
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."
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."
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.
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. The higher-capacity QiaStat-Dx Rise is CE-IVD marked with a planned submission to the FDA in 2025.
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 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.