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Policy

Co-Diagnostics, Inc. Submits First FDA 510(k) Application for Co-Dx PCR Pro Platform

Co-Diagnostics, Inc. announced that the Company has completed its first U.S. Food and Drug Administration application for 510 clearance for the Co-Dx™ PCR Pro™ instrument, and the Co-Dx PCR COVID-19 Test for over-the-counter use.

June 14, 2024

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4 min read

Business

Reveal Genomics® to Evaluate Prospective Real-time Performance of HER2DX® Genomic Test in the United States

Reveal Genomics® to Evaluate Prospective Real-time Performance of HER2DX ® Genomic Test in the United States.

June 18, 2024

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4 min read

Reveal Genomics® HER2DX® Genomic Test Demonstrates Significant Potential in HER2-Positive Advanced Gastric Cancer

Reveal Genomics ® HER2DX ® Genomic Test Demonstrates Significant Potential in HER2-Positive Advanced Gastric Cancer.

June 27, 2024

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5 min read

QIAGEN expands QIAstat-Dx syndromic testing menu in the U.S. with launch of molecular test to improve gastrointestinal care

QIAGEN announced the launch of the QIAstat-Dx Gastrointestinal Panel 2 in the United States.

June 3, 2024

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8 min read

Biotech Bay

Personalis to Participate at the TD Cowen 3rd Annual Tools / Dx Revolution Conference

Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, announced today that Chris Hall, CEO and President, will join a panel and speak at the TD Cowen 3rd Annual Tools / Dx Revolution Conference on Tuesday, June 25, 2024 at 5:30 p.m. Eastern Time.

June 18, 2024

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1 min read

FDA

Indica Labs Receives First FDA Clearance for HALO AP Dx Digital Pathology Platform

Indica Labs announced today that it received FDA clearance for HALO AP Dx, an enterprise digital pathology platform, for primary diagnosis.

May 8, 2024

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4 min read

Press Releases

QIAGEN receives FDA clearance of QIAstat-Dx meningitis/encephalitis panel to support emergency diagnostics

November 4, 2024

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6 min read

Policy

QIAGEN receives FDA clearance for QIAstat-Dx respiratory syndromic testing panel for fast and accurate results

QIAGEN announced that the U.S. Food and Drug Administration has cleared the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use.

May 13, 2024

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6 min read

Press Releases

QIAGEN receives FDA clearance for QIAstat-Dx mini panel to improve precision in outpatient respiratory treatment

October 29, 2024

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7 min read

Biotech Bay

Agilent Receives European IVDR Class C Certification for GenetiSure Dx Postnatal Assay

Agilent Technologies Inc. (NYSE: A) today announced that its GenetiSure Dx Postnatal Assay has received European IVDR Class C Certification.

April 15, 2024

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2 min read