Genedrive MT-RNR1 ID Kit to detect genetic variation and protect hearing in babies: early value appraisal.
The Genedrive MT-RNR1 ID Kit has potential benefits in identifying babies at risk of hearing loss from aminoglycoside due to the MT-RNR1 m.1555A>G variant, allowing for alternative antibiotics to be used instead. However, managing the risk of early access is important, including ensuring timely antibiotics, avoiding unnecessary use of alternative antibiotics, and confirming positive results. The economic evidence suggests cost-effectiveness, but upfront costs may be high. Data should be generated in centers with babies from different ethnicities to promote equality.
Recent Posts
Positive ARTISTRY-2 Trial Results for BIC LEN HIV Regimen
BIC/LEN HIV Regimen Delivers Non-Inferior Results in ARTISTRY-2
Gilead Sciences announced positive topline results from the Phase 3 ARTISTRY-2 trial, demonstrating that the investigational BIC LEN HIV regimen
Accelerating Tec-Dara Multiple Myeloma Therapy Review: A Game Changer for Patients
Accelerating Review for Transformative Multiple Myeloma Therapy
The U.S. Food and Drug Administration (
CHMP Meeting Highlights: December 2025 Advances in New Medicines Approvals
The CHMP meeting highlights from December 2025 reveal major advancements in drug approvals. What were the key outcomes of the EMA's Committee for Medicinal Products for Human Use session held December 8-11? The committee recommended seven new medicines for approval. These target critical areas li...