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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

Press Releases

Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer eligible for HER2-targeted treatment with ZIIHERA

November 25, 2024

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6 min read

Press Releases

NMPA Grants Marketing Approval to the First Co-Developed NGS-Based Companion Diagnostic for Lung Cancer in China

October 11, 2024

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5 min read

News

FDA Approves NGS-Based Companion Diagnostic for First Targeted Therapy for Patients with Grade 2 IDH-Mutant Glioma

October 21, 2024

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4 min read

FDA

Labcorp Receives FDA Approval for First Companion Diagnostic for Use with Pfizer’s Newly Approved Gene Therapy to Treat Patients with Hemophilia B

Labcorp today announced the U.S. Food and Drug Administration (FDA) has approved its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine patient eligibility for treatment with BEQVEZ™ (fidanacogene elaparvovec-dzkt), Pfizer’s recently FDA-approved hemophilia B gene therapy.

April 29, 2024

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3 min read

Business

Foundation Medicine and PMV Pharma Announce Collaboration to Develop Companion Diagnostic for Rezatapopt, a First-In-Class, Investigational, Selective p53 Y220C Reactivator

Foundation Medicine, Inc. and PMV Pharmaceuticals, Inc. announced a partnership to develop Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOne®CDx, as a companion diagnostic for PMV Pharma’s rezatapopt, a first-in-class, investigational therapy for patients with locally advanced or metastatic solid tumors that have a TP53 Y220C mutation.

May 29, 2024

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5 min read