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Revolutionary Medical Breakthroughs of July 2025: Life-Changing Drugs, Diagnostic Wonders & Public Health Milestones

Revolutionary Medical Breakthroughs of July 2025: Life-Changing Drugs, Diagnostic Wonders & Public Health Milestones

On July 2, 2025, the FDA granted accelerated approval to linvoseltamab (Lynozyfic), a BCMA-targeting bispecific antibody, for adults with heavily pretreated relapsed/refractory multiple myeloma, after trials showed a 70% response rate. Also on July 2, 2025, the FDA approved sunvozertinib (Zegfrovy) as the first targeted oral therapy for advanced NSCLC with EGFR exon 20 insertion mutations following chemotherapy. In July 2025, the FDA granted Breakthrough Therapy designation to trastuzumab deruxtecan (T-DXd) plus pertuzumab for HER2-positive metastatic breast cancer. Relutrigine (PRAX-562) received FDA Breakthrough Therapy designation for two rare pediatric epileptic encephalopathies (SCN2A and SCN8A) after a Phase 2 study showed
AI Pathology Breakthrough: Roche’s Lung Cancer Diagnostic Makes FDA History

AI Pathology Breakthrough: Roche’s Lung Cancer Diagnostic Makes FDA History

In April 2025, Roche’s Ventana TROP2 (EPR20043) RxDx test became the first AI-powered diagnostic to receive FDA Breakthrough Device Designation. The device pairs an immunohistochemistry stain for TROP2 with a digital pathology AI algorithm that runs in Roche’s Navify system to analyze NSCLC biopsy slides. The AI calculates a Normalized Membrane Ratio (NMR), the ratio of surface TROP2 to internal TROP2, to classify tumors as TROP2-positive or -negative. The Ventana TROP2 RxDx is a full diagnostic system, including Roche’s slide scanners, the Navify image management software, the Ventana TROP2 IHC kit, and the AI algorithm. A positive NMR score thresholds
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