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FDA Warning Letter
FDA issues warning for Cue Health COVID-19 tests
The U.S. Food and Drug Administration (FDA) issued a warning to consumers and healthcare providers not to use Cue Health's COVID-19 over-the-counter test and its COVID-19 test intended for point-of-care settings due to an increased risk of false results.
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Biomarker extraction through ultrasound shows promise for cancer detection
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Northwell Health Cancer Institute opens molecular diagnostics laboratory
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Danaher launches collaboration with Johns Hopkins University on TBI diagnostics
May 9, 2024
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Business Insights
FDA Warning Letter
FDA issues warning for Cue Health COVID-19 tests
Trends and Finance
Northwell Health Cancer Institute opens molecular diagnostics laboratory
FDA Clearance
Qiagen gets FDA clearance for respiratory syndromic testing panel
Emergency Use Authorization
iHealth gets EUA for combination COVID-19/influenza at-home test
Diagnostic Technologies
Emerging Technology
Biomarker extraction through ultrasound shows promise for cancer detection
Trends and Finance
Northwell Health Cancer Institute opens molecular diagnostics laboratory
FDA Clearance
Qiagen gets FDA clearance for respiratory syndromic testing panel
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Qiagen partners with FBI on forensics assay
Diseases
Emergency Use Authorization
iHealth gets EUA for combination COVID-19/influenza at-home test
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Danaher launches collaboration with Johns Hopkins University on TBI diagnostics
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University of Florida researchers develop CRISPR-based assay for HPV detection
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Geneoscopy receives FDA approval for CRC screening test
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Qiagen gets FDA clearance for respiratory syndromic testing panel
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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.
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FDA said no to proficiency testing for LDT quality
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Cue Health to cut 230 jobs in restructuring plan
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Quest Diagnostics to add digital pathology lab, AI pathology center in Tennessee
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Astellas and Poseida to collaborate on oncology cell therapies
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