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Biotech Beach

FDA Grants EUA to Wondfo’s WELLlife™ COVID-19/Influenza A&B Test Supported by DCN Dx Clinical Research

DCN Dx, a leading contract research organization for in vitro diagnostics, today acknowledges the FDA’s Emergency Use Authorization (EUA) of the WELLlife™ COVID-19/Influenza A&aB Test, developed by Wondfo USA.

May 15, 2024

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3 min read

Business

DCN Dx Bolsters Board with Appointment of Former Meridian Biosciences CEO Jack Kenny

DCN Dx, a global leader in the end-to-end development, manufacturing, and commercialization of point-of-use tests, announces the appointment of industry veteran Jack Kenny to its board of directors.

March 12, 2024

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2 min read

Press Releases

DCN Dx’s Clinical Research Helps Secure FDA Authorization for Cepheid HCV Test

July 10, 2024

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2 min read

Biotech Beach

DCN Dx and Mapp Biopharmaceutical Announce Subcontract

DCN Dx announced a subcontract with Mapp Biopharmaceutical, Inc., a developer of novel pharmaceuticals for the prevention and treatment of infectious diseases, focusing on unmet needs in global health and biodefense.

February 1, 2023

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3 min read

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

Press Releases

T2 Biosystems Announces Sale of Four T2Dx Instruments to Existing European Distributor

December 18, 2024

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5 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