The role of URO17™ biomarker to enhance diagnosis of urothelial cancer – First UK pilot data
BAUS ePoster online library. Vasdev N. 11/10/20; 304116; P12-2
Mr. Nikhil Vasdev
Mr. Nikhil Vasdev
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The role of URO17™ biomarker to enhance diagnosis of urothelial cancer – First UK pilot data

Vasdev N1, Hampson A1, Agarwal S1, Swamy R1, Chilvers M1, Jahanfard S2, Kim N2
1Lister Hospital, Stevenage, United Kingdom, 2kDX Diagnostics Inc, Campbell, USA

Introduction & objectives:
We evaluate the diagnostic accuracy and sensitivity of URO17™ (Oncoprotein Keratin 17) urinary biomarker for the detection of urothelial cancer in a prospective blinded validation study. This is first data from the UK.
Materials & methods:
After receiving both local and national ethics/protocol approval,115 patients were consented and recruited into the study. All patients were scheduled to undergo cystoscopic investigations. 22 patients were excluded for reasons such as biopsies not being taken and catheters being in situ.

Results:
The full cohort consisted of 93 participants, 65 males and 28 females, with an average age of 71.3. 49% (46) were known to have previously had a diagnosis of a urothelial malignancy. The malignancies detected included both muscle-invasive and non-muscle invasive tumours, and tumours of all grades and carcinoma in situ. URO17™ was shown in the full cohort (n=93) to have an overall sensitivity of 100% and a specificity of 60.9%. In the sub analysis for new patients undergoing investigation had a sensitivity of 100% and specificity of 89%,with a negative predictive value of 1 and a positive predictive value of 0.933.

Conclusions:
URO17™ urine immunostaining can accurately exclude urothelial malignancy with minimal requirements and will indicate patients that should be thoroughly investigated. While this would not replace cystoscopy as the gold standard, and histological analysis is still required for staging. URO17™ is an effective adjunct that may help reduced the number of unnecessary cystoscopies. URO17™ was positive in every case of bladder cancer and no cases were found if there was a negative URO17™ result.
The role of URO17™ biomarker to enhance diagnosis of urothelial cancer – First UK pilot data

Vasdev N1, Hampson A1, Agarwal S1, Swamy R1, Chilvers M1, Jahanfard S2, Kim N2
1Lister Hospital, Stevenage, United Kingdom, 2kDX Diagnostics Inc, Campbell, USA

Introduction & objectives:
We evaluate the diagnostic accuracy and sensitivity of URO17™ (Oncoprotein Keratin 17) urinary biomarker for the detection of urothelial cancer in a prospective blinded validation study. This is first data from the UK.
Materials & methods:
After receiving both local and national ethics/protocol approval,115 patients were consented and recruited into the study. All patients were scheduled to undergo cystoscopic investigations. 22 patients were excluded for reasons such as biopsies not being taken and catheters being in situ.

Results:
The full cohort consisted of 93 participants, 65 males and 28 females, with an average age of 71.3. 49% (46) were known to have previously had a diagnosis of a urothelial malignancy. The malignancies detected included both muscle-invasive and non-muscle invasive tumours, and tumours of all grades and carcinoma in situ. URO17™ was shown in the full cohort (n=93) to have an overall sensitivity of 100% and a specificity of 60.9%. In the sub analysis for new patients undergoing investigation had a sensitivity of 100% and specificity of 89%,with a negative predictive value of 1 and a positive predictive value of 0.933.

Conclusions:
URO17™ urine immunostaining can accurately exclude urothelial malignancy with minimal requirements and will indicate patients that should be thoroughly investigated. While this would not replace cystoscopy as the gold standard, and histological analysis is still required for staging. URO17™ is an effective adjunct that may help reduced the number of unnecessary cystoscopies. URO17™ was positive in every case of bladder cancer and no cases were found if there was a negative URO17™ result.
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