Positive endorsement for sure, a pity the AUA are not so forward looking as having CxBladder as part of the go to standard is the big challenge for Pacific Edge.
AUA has just released its 2020 update:
http://www.auanet.org/guidelines/bla...sive-guideline
In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)
In a patient with a history of low-risk cancer and a normal cystoscopy, a clinician should not routinely use a urinary biomarker or cytology during surveillance. (Expert Opinion)
From discussion doc guideline 9
The update review identified six new observational studies (in seven publications) including 1,604 participants and one systematic review relevant to this guideline statement. Since the guideline’s initial publication in 2016, several new urinary biomarkers have been developed to detect recurrent bladder cancer in NMIBC patients on surveillance.92-94 One such marker is CxBladder Monitor. It was designed as a high sensitivity rule-out test such that a negative result can be used to defer cystoscopy or confirm negative cystoscopy. In a cohort of 763 NMIBC patients on surveillance, CxBladder Monitor had a 93% sensitivity and 97% negative predictive value for recurrent NMIBC; however, the test specificity was not reported. Approximately one-third of patients had a negative test and could potentially avoid cystoscopy. The test performed well for both low- and high-grade recurrences92 and outperformed urine cytology, NMP22, and UroVysion FISH.95 While a patient with a negative test is unlikely to have recurrent NMIBC, a non-negative test requires continued cystoscopic surveillance and is not necessarily diagnostic of a recurrence. Although the early data on CxBladder Monitor are promising, further validation studies are needed to determine if a negative test is sufficient to defer surveillance cystoscopy and what the clinical implications are of a non-negative test.
From discussion doc guideline 10
The previously discussed CxBladder Monitor was designed to detect recurrent bladder cancer in NMIBC patients on surveillance. Although this biomarker performed well for intermediate- and high-risk NMIBC patients in a large cohort study, its sensitivity was only 53% in a small subset of patients with an EORTC risk score of 0, which is equivalent to AUA low-risk.92 As such, there is currently insufficient evidence to recommend CxBladder Monitor during surveillance for low-risk patients.