Litt usikker om innholdet av høringsperioden for foreslått Medicare-dekning for urinbaserte biomarkører som var her tidligere i sommer er kommentert?
Men her en transcript fra Novitas sin høringsrunde hvor COO fra Vesica (som PHO har kjøpt) deltok og argumenterte (godt?) for inkludering av AssureMDx.
Dette er en potensiell trigger, for hvis inkludert i pågående LCD vil AssureMDx nå markedet lenge før guidingen til PHO. (Potensielt allerede tidlig 2027).
Novatis høringsrunde om urinbaserte biomarkører ved mikrohematuri
**Christopher Thibodeau**
Yes. Good afternoon. And thank you again to the entire panel for allowing us to present today. My name is Christopher Thibodeau, and my conflict of interest is that I do represent Vesica Health, and our product is called AssureMDx, which we’ll discuss here shortly. And if I may ask a quick preliminary question, will you advance the slides on your end if I say?
Dr. Megan Landsverk
Yes, sir. Yep. You can just say, “Next slide, please,” and I’ll advance.
Christopher Thibodeau
That’s perfect. Thank you, Dr. Landsverk. So, thank you again to the team for allowing us to comment on the proposed LCD. Vesica Health developed AssureMDx, a urine-based genomic assay that has been evaluated in over 1,192 hematuria patients across three peer-reviewed clinical validation studies-- is included in the 2025 AUA SUFU Microhematuria Guideline. We strongly support the proposed LCD and believe it represents an important step forward for patients with microhematuria. To strengthen the proposed policy and improve access for Medicare beneficiaries, we respectfully propose two recommendations. Next slide, please. Perfect. Thank you. Our first recommendation is to include AssureMDx as a covered test under the final LCD and billing and coding article. AssureMDx is a urine-based genomic assay intended to aid in the evaluation of patients presenting with hematuria who may be at risk for urothelial carcinoma. AssureMDx is intended for patients presenting with hematuria and is designed to support risk stratification as part of the diagnostic evaluation. As shown here, the assay provides clinically actionable information that helps identify patients at very low likelihood of bladder cancer from those at higher risk who may benefit from further urologic evaluation. This intended use is directly aligned with the objective of the proposed LCD and the risk stratified framework outlined in the AUA Microhematuria Guideline.
Next slide, please. For context, AssureMDx integrates DNA methylation biomarkers, somatic mutation biomarkers, and hematuria type, within a locked algorithm, to support bladder cancer risk assessment. Next slide, please. AssureMDx demonstrates high performance across the patient populations relevant to the proposed LCD and the largest prospective multi-center validation study on a cohort of 838 subjects with hematuria, the assay achieved 96% overall sensitivity and greater than 99% negative predictive value. AssureMDx delivered strong performance for the detection of early stage disease, with a combined sensitivity of 95.9% for stage zero and stage one urothelial carcinoma, when there’s the greatest opportunity for cure. In patients presenting with microhematuria, AssureMDx achieved 93% sensitivity and 92% specificity, with greater than 99% negative predictive value and an area under the curve of 0.971. Importantly, performance was also consistent in patients under and over age 66 years, with AUC of 0.95 in both groups. These findings demonstrate that the clinical validity of AssureMDx is maintained in Medicare-aged patients. Collectively, these findings support the clinical validity of AssureMDx across a broad microhematuria population.
Next slide, please. We support coverage for validated urine-based biomarkers in appropriately selected patients with microhematuria, a risk-stratified approach consistent with the AUA guideline, and use of biomarkers that demonstrate clinical validity, robust diagnostic performance, and high negative predictive value. Our first recommendation is to include AssureMDx within the final coverage framework. The draft LCD discusses two of our clinical validation studies. And the AssureMDx evidence base includes three peer-reviewed clinical validation studies, as I mentioned, involving 1,192 patients with hematuria. Published performance meets or exceeds the clinical criteria outlined in the proposed policy. Our second recommendation is to clarify that Medicare beneficiaries, including men aged 60 years and older, remain eligible for bladder cancer detection testing and are not excluded solely on the base of age under the AUA risk stratification framework. As demonstrated in our clinical validation studies, AssureMDx maintains consistently strong performance above and below age 66 years, with an AUC of 0.95 for both groups. We respectfully report the finalization of the proposed LCD and believe the published evidence supports inclusion of AssureMDx within the final coverage framework while preserving access for appropriately selected Medicare beneficiaries with microhematuria. Thank you for your consideration.
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