Qiagen gets FDA clearance for respiratory syndromic testing panel

LabPulse.com staff writers
May 14, 2024
Fda Button Social

Qiagen announced that it has received U.S. Food and Drug Administration (FDA) clearance for its QIAstat-Dx respiratory syndromic testing panel for clinical use.

The QIAstat-Dx Respiratory Panel Plus, previously authorized under an FDA emergency use authorization as the QIAstat-Dx Respiratory SARS-CoV-2 Panel, covers 21 viral and bacterial targets, amplifying many genetic targets at once using real-time polymerase chain reaction (PCR) technology to deliver results in an hour. Furthermore, syndromic testing systems like QIAstat-Dx enable the detection of co-infections.

Qiagen recently launched its upgraded QIAstat-Dx Analyzer 2.0 diagnostic system, which introduces an application that allows users to view, comment on, and confirm diagnostic test results directly from their desktop and mobile devices in any location.

Qiagen is currently working on expanding the QIAstat-Dx test menu in the U.S.; a meningitis/encephalitis panel is in development, and a gastrointestinal panel is currently under FDA review.        

Latest in FDA Clearance
Sepsis Bacteria Social
BioMérieux receives 510(k) certification for antimicrobial testing system
August 21, 2024
Treponema pallidum, the bacteria that cause syphilis.
NowDiagnostics granted FDA marketing authorization for OTC syphilis test
August 16, 2024
Visit our Molecular Diagnostics Community
Sponsored
Visit our Molecular Diagnostics Community
April 5, 2024
Fda Button Social
Labcorp gets FDA de novo authorization for solid tumor mutation liquid biopsy test
August 5, 2024
Related Stories
Test Tubes Social
Collaboration
Qiagen, Myriad Genetics to develop HRD test
Lab Pcr Tubes Dna Social
PCR
Qiagen partners with FBI on forensics assay
Global Collaboration Business Social
Collaboration
Qiagen, Myriad Genetics to collaborate on cancer companion diagnostics
Visit our Molecular Diagnostics Community
Sponsor Content
Visit our Molecular Diagnostics Community
More in FDA Clearance
BioMérieux receives 510(k) certification for antimicrobial testing system
By LabPulse.com staff writers
BioMérieux has received 510(k) clearance from the U.S. Food and Drug Administration for its Vitek Reveal AST system, which reports antimicrobial susceptibility testing (AST) results directly from positive blood cultures.
August 21, 2024
Sepsis Bacteria Social
NowDiagnostics granted FDA marketing authorization for OTC syphilis test
By LabPulse.com staff writers
NowDiagnostics has been granted de novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its First To Know over-the-counter (OTC) syphilis test.
August 16, 2024
Treponema pallidum, the bacteria that cause syphilis.
Thermo Fisher gets FDA 510(k) clearance for HLA typing CDx
By LabPulse.com staff writers
Thermo Fisher's SeCore CDx HLA A Sequencing System has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for use as a companion diagnostic (CDx) with Adaptimmune's T-cell receptor therapy Tecelra for synovial sarcoma.
August 7, 2024
Fda Sign Dc Social
Labcorp gets FDA de novo authorization for solid tumor mutation liquid biopsy test
By LabPulse.com staff writers
Labcorp has received de novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its PGDx Elio Plasma Focus Dx kitted assay, a pan-solid tumor liquid biopsy test that enables tumor mutation profiling.
August 5, 2024
Fda Button Social
Thermo Fisher Scientific gets FDA 510(k) clearance for multiple myeloma precursor assays
By LabPulse.com staff writers
Thermo Fisher Scientific received an extended 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Optilite Freelite assays for evaluating monoclonal gammopathy of undetermined significance, a precursor to multiple myeloma.
July 29, 2024
Multiple Myeloma Social
Diasorin C. auris test gets FDA de novo authorization
By LabPulse.com staff writers
Diasorin has received de novo authorization from the U.S. Food and Drug Administration (FDA) for its test kit for Candida auris, a multidrug-resistant fungal pathogen common in healthcare settings.
July 16, 2024
Candida 3 D Social
FDA approves Lilly’s Alzheimer’s disease treatment
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Kisunla (donanemab) for the treatment of Alzheimer’s disease.
July 3, 2024
Amyloid Plaque Alzheimer2 Social
FDA greenlights BioMérieux's mini respiratory, sore throat panel for POC testing
By LabPulse.com staff writers
BioMérieux received special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel Mini respiratory viral and bacterial testing device designed for point-of-care (POC) testing.
June 28, 2024
Business Regulation Graphic Social Resized
FDA grants 510(k) clearance to Genetic Signature for parasitic GI infection kit
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Genetic Signature's EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated molecular workflow.
June 7, 2024
Lab Petri Microbiology Social
Roche garners FDA EUA for 4-in-1 respiratory panel
By LabPulse.com staff writers
Roche has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Cobas Liat SARS-CoV-2, influenza A/B, and RSV nucleic acid test.
June 10, 2024
Fda Sign Dc Social
Diasorin receives FDA 510(k) clearance for fungal infection panel
By LabPulse.com staff writers
Diasorin has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Liaison Plex Yeast Blood Culture assay, the second molecular multiplexing panel developed for the firm's Liaison Plex system.
June 6, 2024
Fda Button Social
BioMérieux TBI test receives FDA 510(k) clearance
By LabPulse.com staff writers
BioMérieux has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its assay that screens for mild traumatic brain injury, including concussion.
May 29, 2024
Football Player Concussion Social
Page 1 of 8
Next Page