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FDA

U.S. Food and Drug Administration (FDA) Approves FoundationOne®Liquid CDx as a Companion Diagnostic for AKEEGA® (niraparib and abiraterone acetate) for Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for AKEEGA® (niraparib and abiraterone acetate) from Janssen Biotech, Inc.

July 1, 2024

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6 min read

Biotech Bay

Guardant Health Receives EU IVDR Certification for Guardant360® CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746).

May 21, 2024

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8 min read

Telix Completes TLX250-CDx (Zircaix™) BLA Submission for Kidney Cancer Imaging

Telix Pharmaceuticals Limited announces that it has completed the submission of a Biologics License Application to the United States Food and Drug Administration for its investigational radiodiagnostic PET1 agent, TLX250-CDx, for the characterisation of renal masses as clear cell renal cell carcinoma.

June 2, 2024

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7 min read

Policy

TLX101-CDx (Pixclara™) Granted FDA Fast Track Designation

Telix Pharmaceuticals Limited announces that the United States Food and Drug Administration has granted Fast Track designation for the Company’s investigational glioma imaging product, TLX101-CDx.

April 15, 2024

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9 min read

Press Releases

Hemogenyx Pharmaceuticals PLC Announces CDX Development Update

September 2, 2024

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3 min read

Press Releases

FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent

October 24, 2024

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8 min read

Business

Nanostics and Protean BioDiagnostics Partner to Launch CDX Prostate for Men at Risk of Having Aggressive Prostate Cancer in the United States

September 24, 2024

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3 min read

FDA

Pillar Biosciences oncoReveal™ CDx pan-cancer solid tumor IVD now FDA approved for general tumor profiling on the Illumina MiSeq™ Dx System

Pillar Biosciences, Inc., the leader in Decision Medicine™ today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Premarket Approval (PMA) supplement application for its oncoReveal™ CDx pan-cancer solid tumor in vitro diagnostic (IVD).

April 23, 2024

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3 min read

FDA

U.S. Food and Drug Administration Approves FoundationOne®Liquid CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation

October 11, 2024

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4 min read

Press Releases

EU Notified Body (BSI Netherlands) and the EMA Grant Approval of the LeukoStrat® CDx FLT3 Mutation Assay for VANFLYTA® Therapy in the EU and EEA

October 8, 2024

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2 min read