FDA clears Qiagen’s respiratory syndromic testing panel
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Key takeaways:
- Qiagen’s respiratory panel can detect 21 viral and bacterial pathogens that can cause upper respiratory infections.
- The panel generates results in about 1 hour with less than 1 minute of hands-on time.
The FDA has cleared Qiagen’s respiratory syndromic testing panel, the company announced Monday.
QIAstat-Dx Respiratory Panel Plus is designed to detect 21 viral and bacterial pathogens that can cause upper respiratory infections and aid in diagnosing these infections quickly, Qiagen said.
According to the company, the panel can deliver results quickly with less than 1 minute of hands-on time by assessing many genetic targets at once using real-time PCR technology.
The company said the panel can make it faster to detect infections and subsequently reduce the need for additional testing and unnecessary antibiotic use.
“The QIAstat-Dx Respiratory Panel Plus addresses the challenges faced by clinicians in diagnosing respiratory infections, streamlining the process and providing accurate results in about 1 hour,” Fernando Beils, Qiagen’s senior vice president and head of molecular diagnostics business, said in a press release.
“This comprehensive diagnostic tool will improve patient care, support responsible antimicrobial stewardship, and reduce the burden on health care systems,” he added.
Previously, the system was available under an FDA emergency use authorization as a SARS-CoV-2 panel. Data from the 2021 authorization showed that the panel could detect SARS-CoV-2 antigens in people with active infections within 2 to 15 minutes, with a sensitivity of at least 80% and a specificity of 98%.
The company said it has plans to expand the QIAstat-Dx portfolio to include a meningitis and encephalitis panel, and a gastrointestinal panel — which is currently under FDA review.
Using similar technology, the company has also partnered with the FBI to create a novel digital PCR assay that can help forensic specialists detect and quantify minimal amounts of DNA — even using samples that have been compromised by age or environmental factors — with high accuracy.
References:
- Qiagen partners with FBI to develop digital PCR assay for QIAcuity for use in forensics. https://corporate.qiagen.com/English/newsroom/press-releases/press-release-details/2024/QIAGEN-partners-with-FBI-to-develop-digital-PCR-assay-for-QIAcuity-for-use-in-forensics/default.aspx. Published May 7, 2024. Accessed May 13, 2024.
- Qiagen receives FDA clearance for QIAstat-Dx respiratory syndromic testing panel for fast and accurate results. https://corporate.qiagen.com/English/newsroom/press-releases/press-release-details/2024/QIAGEN-receives-FDA-clearance-for-QIAstat-Dx-respiratory-syndromic-testing-panel-for-fast-and-accurate-results/default.aspx. Published May 13, 2024. Accessed May 13, 2024.
- Qiagen receives U.S. FDA emergency use authorization for rapid portable test that can analyze over 30 samples per hour for SARS-CoV-2 antigen. https://corporate.qiagen.com/newsroom/press-releases/press-release-details/2021/QIAGEN-receives-U.S.-FDA-emergency-use-authorization-for-rapid-portable-test-that-can-analyze-over-30-samples-per-hour-for-SARS-CoV-2-antigen/default.aspx. Published Aug. 6, 2021. Accessed May 13, 2024.
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