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Trial met primary and secondary endpoints and confirmed favourable safety and tolerability profile, indicating TLX250-CDx has the potential to become a new clinical standard in the identification and characterisation of clear cell renal cell carcinoma (ccRCC): Primary endpoint met: Sensitivity of 84% and specificity of 84% in all three readers (86% / 87% overall) Considerably exceeds confirmatory trial sensitivity and specificity success targets Key secondary endpoints met, achieving 85% sensitivity and 89% specificity in small renal masses (cT1a 4cm) Full data set: 93% positive predictive value; 75% negative predictive value; 86% accuracy (secondary endpoints) cT1a masses:93% positive predictive value; 78% negative predictive value; 87% accuracy Case study presented on a 1cm mass, demonstrating potential for clinical decision making with renal masses 2cm Favourable safety and tolerability profile of TLX250-CDx also confirmed MELBOURNE, Australia, Feb. 20, 2023 /PRNewswire/ Telix Phar

United statesLos angelesKyahn williamsonColin haywardPeter muldersBrian shuchEuropean association of urologyTelix pharmaceuticalsAmerican society of clinical oncologyDrug administrationInstitute of urologic oncology los angelesTelix groupAustralian securities exchangeAustralian therapeutic goods administrationKidney cancer programCorporate communications