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Improved Detection of Bladder Cancer in Diagnosis and
Surveillance Patients Using aPoint-of-Care Proteomic Assay
Barry Stein, M.D.
G. Katz, M.D.
NMP22 Clinical Investigation Group
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Study Design
• Two prospective studies: 23 facilities in 10 states; academic, private practice and VA
• 1,331 patients scheduled for cystoscopy due to increased risk of bladder cancer (hematuria (92%), history of smoking, irritative voiding symptoms), and 668 patients with a history of bladder cancer under surveillance for recurrence
• Voided urine sample for analysis of NMP22 marker (30 min, CLIA waived) and cytology prior to diagnostic cystoscopy
• Urologists were blinded to NMP22 and cytology results while performing and reporting the result of cystoscopy
• Further workup was based on clinical findings and results of cystoscopy and cytology
• TCC was diagnosed based on pathology
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Av Age yr %male %female
TotalTCC
Diagnosis DemographicsTotal Tested Population (1331) vs Patients with TCC (79)
TCC 79 / 1,331 (6%)
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Sensitivity for Detecting TCC: Diagnosis
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Ta T1 Tis T2 + LowGrade
Md Grade HighGrade
Cytology = 16%NMP22 Test = 57%
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Improved Detection withNMP22 BladderChek Test and Cystoscopy
Muscle Invasive All Cancers
Cystoscopy 91% 94%& NMP22 Test (10/11) (74/79)
Cystoscopy 55% 86%alone (6/11) (68/79)
Cancers not seen by cystoscopy but detected by NMP22 Test:Bladder CIS, T2, T3; Ureter T2; Renal Pelvis T1, T3
P=0.014
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Specificity
No GU DiseaseNo Cancer
NMP22 90% 86%Test (512/567) (1072/1249)
Cytology 99% 99%(544/547) (1198/1208)
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NED BPH Cystitis Calculi
NMP22
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Av Age yr %male %female
TotalTCC
Monitoring (Surveillance) Demographics
Total population = 668Patients with tumors = 103 (15%)
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Sensitivity for Detecting Cancer: Monitoring
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Ta T1 Tis T2 + LowGrade
Md Grade HighGrade
Cytology = 12%NMP22 Test = 50%
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Improved Detection withNMP22 BladderChek Test and Cystoscopy
Muscle Invasive All Cancers
Cystoscopy 91% 99%& NMP22 Test (10/11) (102/103)
Cystoscopy 64% 91%alone (7/11) (94/103)
Cancers not seen by cystoscopy but detected by NMP22 Test:Ta G1, 2 Cis G3, T1 G3, 2 T2 G3, 2 T4 G3
P=0.005
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Specificity
NMP22 Test 87% (493/565)
Cytology 97% (535/552)
Cystoscopy 98% (556/565)
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NED BPH Cystitis Calculi
NMP22
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Predictive Value
PPV NPV
NMP22 Test 41% 91%(51/123) (493/545)
Cytology 41% 86%(12/29) (535/621)
Cystoscopy 91% 98%(94/103) (556/565)
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Bladder Cancer Detection AlgorithmResult: >99% Negative Predictive Value
Action: Standard Surveillance
Pathway #1
NMP22 Test(NEG)
Cystoscopy (NEG)
Pathway #2
NMP22Test (POS)
Cystoscopy (NEG)
Result: Potential for undetected cancer
Action: - More intensive investigation - Review/Schedule upper tract tests
- Follow up within shorter interval
Pathway #3
NMP22Test (POS)
Cystoscopy (POS)
Result: - Up to 99% of cancers detected; - Elevated risk of muscle invasive and/or high grade cancer
Action: Prioritize for biopsy
Pathway #4
NMP22 Test(NEG)
Cystoscopy (POS)
Result: Greater likelihood nonmuscle invasive and low grade cancer
Action: Standard biopsy
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Conclusions• Cystoscopy combined with the NMP22 BladderChek
Test detected significantly more bladder tumors than cystoscopy alone
• NMP22 test detected high grade cancers not visualized by cystoscopy
• NMP22 test is significantly more sensitive than cytology for detecting cancer
• Negative Predictive Value of the NMP22 test is greater than cytology (P = 0.012) with equivalent Positive Predictive Value
• Test can be performed in the office with results available in 30 minutes at half the cost of cytology