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QIAGEN’s QIAstat-Dx Respiratory Syndromic Testing Panel Gains the US FDA’s Clearance to Diagnose Upper Respiratory Infections

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QIAGEN

QIAGEN’s QIAstat-Dx Respiratory Syndromic Testing Panel Gains the US FDA’s Clearance to Diagnose Upper Respiratory Infections

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  • Following the EUA, the company’s QIAstat-Dx Respiratory Panel Plus syndromic test has been cleared by the US FDA to diagnose upper respiratory infections, covering over 21 viral & bacterial targets. It is designed in the Analyzer (combines up to 4 Analytical Modules) & Rise higher-capacity versions (test for up to 160 tests per day using 8 Analytical Modules)
  • The test utilizes QIAstat-Dx’s real-time PCR technology to amplify the genetic samples for providing outcomes incl. Cycle threshold (Ct) values & amplification curves in an hour
  • Furthermore, the company anticipates QIAstat-Dx portfolio expansion across the US with a Gastrointestinal Panel under the US FDA review & a Meningitis/Encephalitis Panel

Ref: QIAGEN | Image: QIAGEN

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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