Local biopharma taps Cardinal Health as distributor for non-invasive kidney cancer diagnostic

Biotech News: A Melbourne-based biopharma company has collaborated with Cardinal Health as the distributor for its PET agent for the diagnostic imaging of kidney cancer in the U.S. This partnership is part of Telix Pharmaceuticals’ strategy to ensure widespread availability of Zircaix (TLX250-CDx) ahead of its commercial launch.

Current diagnostic methods, including imaging and renal biopsies, are not only limited but also carry risks. Many patients undergo unnecessary surgeries, with up to 30% resulting in benign findings after the removal of non-cancerous masses. The non-invasive nature of Zircaix imaging offers a significant advantage, particularly for patients at risk of complications from surgical biopsies.

Kevin Richardson, CEO of Telix Precision Medicine, emphasised, “We are pleased to build on our existing relationship with Cardinal Health to maximise patient access to this breakthrough product for non-invasive kidney cancer diagnosis.”

Richardson continued, “Through their extensive nuclear pharmacy network, which ensures broad geographic coverage and flexible scheduling, Cardinal Health has played a pivotal role in the successful commercialisation of Illuccix PSMA-PET imaging. We eagerly anticipate their integration of Zircaix into their U.S. portfolio.”

The Phase III ZIRCON trial assessed Zircaix PET/CT imaging’s sensitivity and specificity in detecting clear cell renal cell carcinoma (ccRCC) in patients with renal masses ≤7 cm, scheduled for nephrectomy. Results indicated Zircaix achieved an average sensitivity of 86%, specificity of 87%, and a positive predictive value of 93%. All three radiology readers met primary and secondary endpoints, surpassing pre-specified thresholds.

Mike Pintek, President of Cardinal Health Nuclear & Precision Health Solutions, commented, “This new agreement builds upon our successful relationship with Telix and our continued commitment to supporting innovative diagnostics and therapeutics addressing cancer patients today.

“Pending regulatory approval, our extensive commercial distribution infrastructure and expertise will facilitate reliable supply of Zircaix throughout the U.S. to help diagnose kidney cancer.”

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