TEST:

ADXBLADDER

"Based on the results of this simulation, a marker-supported follow-up of patients with HR NMIBC is safe and offers the option to significantly reduce the number of WLCs. Further research focusing on prospective randomized trials is needed to finally find a way to implement urine markers into clinical decision-making."

P=N/A; Trial completion date: Oct 2022 --> Apr 2023 | Trial primary completion date: Oct 2022 --> Jan 2023

"Urinary biomarkers might have a complementary place in bladder cancer diagnosis and NMIBC surveillance. However, their clinical benefit remains to be confirmed."

P=N/A; N=650; Recruiting; Sponsor:Arquer Diagnostics Ltd

MCM5 has an overall moderate diagnostic accuracy for detecting BC. Subgroup analysis revealed good diagnostic performance in patients with high-grade tumors and primary diagnosis of symptomatic patients.

Patients with LG pTa tumor at the previous diagnosis, for which the risk of HG/CIS recurrence is low and the ADXBLADDER NPV for ruling out HG/CIS recurrence is 99.15%, are ideally suited for a less intensive, personalized follow-up surveillance strategy using ADXBLADDER, with omission of cystoscopy for ADXBLADDER-negative patients.

There is not enough data to reliably assess their use in the primary diagnostic setting. These results have to be confirmed in larger cohort as well as in head-to-head comparative studies.

"Our analyses support high diagnostic accuracy of the studied novel UBTs, supporting their utility in the NMIBC surveillance setting. All of these might potentially help prevent unnecessary cystoscopies safely. There are not enough data to reliably assess their use in the primary diagnostic setting. These results have to be confirmed in a larger cohort as well as in head-to-head comparative studies. Nevertheless, our study might help policymakers and stakeholders evaluate the clinical and social impact of the implementation of these tests into daily practice."

No abstracts available

No abstracts available

The main biomarker objective should be to rule out high grade tumor recurrence without the need for any invasive procedures. Nevertheless, the clinical implementation of these biomarkers in the follow up of NMIBC has to be further investigated in prospective randomized trials for low as well as high grade tumors.

We recruited 856 patients and demonstrated that the new urine test can detect bladder cancer with a high degree of accuracy, performing better than the most commonly used urine test-urine cytology. In conclusion, this novel ADXBLADDER urine test can be used to help detect bladder cancers and it can replace the current, standard urine test.

This large blinded prospective study demonstrates that in the follow-up of NMIBC patients ADXBLADDER is able to exclude the presence of the most aggressive tumours with a NPV of 99%. These results indicate that ADXBLADDER could be incorporated in the follow-up strategy of NMIBC.

P;ADXBLADDER has a moderate sensitivity and poor specificity in detecting NMIBC recurrence. However, it properly diagnoses patients with T1+ stage recurrence or high-grade tumors.

ADXBLADDER detection of both LG and HG NMIBC recurrence is superior to that of cytology, with ADXBLADDER able to exclude the presence of HG recurrence in 97.8% of cases compared to cytology's 97.1%. These results reveal a promising case for ADXBLADDER as a more reliable alternative to urine cytology in the follow up of NMIBC.

This large blinded prospective study demonstrates that in the follow up of NMIBC patients ADXBLADDER is able to exclude the presence of the most aggressive tumours with an NPV of 99%. These results indicate that ADXBLADDER could be incorporated in the follow up strategy of NMIBC.

ADXBLADDER demonstrates significantly superior sensitivity when compared to cytology for NMIBC recurrences (p=0.0002), detecting at least twice the number of recurrences than cytology for LG, HG and CIS. These results reveal a compelling case for ADXBLADDER to replace cytology in the follow up of NMIBC.