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URO17™ Bladder Cancer Test

Accurate, Cost Effective, Non-Invasive – FDA Designated “Breakthrough Device” Significant New Revenue Stream

> 95% Sensitivity, > 90% Specificity, 100% NPV, 91% PPV

Detects both high and low grade bladder cancer

Risk stratification tool for additional workup (i.e., Cystoscopy, UroVysion™ FISH)

  • Acupath – first lab to offer nationwide (launched July 2019)
  • Used in conjunction with urine cytology or as a stand-alone test
  • Non-invasive, inexpensive, and paid in-network by most insurance plans
  • FDA designated “Breakthrough Device”; CE Approved
  • 100% NPV – provides confirmation of negative / benign urine cytology results
  • Triages indeterminate (atypical / suspicious) cytology results and helps to rule in or out additional diagnostic procedures and tests
  • Detects both low and high grade urothelial carcinoma

Keratin 17 is a sensitive and specific biomarker of urothelial neoplasia

Modern Pathology

Abstract – There is a clinical need to identify novel biomarkers to improve diagnostic accuracy for the detection of urothelial tumors. The current study aimed to evaluate keratin 17 (K17), an oncoprotein that drives cell cycle progression in cancers of multiple anatomic sites, as a diagnostic biomarker of urothelial neoplasia in bladder biopsies and in urine cytology specimens. We evaluated K17 expression by immunohistochemistry in formalin-fixed, paraffin embedded tissue specimens of non-papillary….

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The role of URO17™ biomarker to enhance diagnosis of urothelial cancer in new hematuria patients—First EuropeanData

Introduction and objectives: Novel biomarker research is vital for the progression of safe and thorough diagnostic medicine. There is now a need to improve the diagnosis of bladder cancer via a noninvasive urine test while balancing the risks of harm from investigational procedures, such as cystoscopy and radiological tests, against the likelihood of malignancy. We evaluate the diagnostic accuracy and sensitivity of Uro17™ urinary biomarker for the….

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Validation of a Novel Cytologic Biomarker for Urothelial Carcinoma

Stony Brook University

Introduction – Cytology and cystoscopy have limited sensitivity and specificity for the diagnosis of urothelial carcinoma (UC), due to inflammatory atypia, sampling errors, and other clinicopathologic factors that may obscure test results. Therefore, there remains an unmet clinical need to identify biomarkers to improve the diagnostic accuracy to detect UC. Prior research from our laboratory established that Keratin17(K17) Immunocytochemistry (ICC)…

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“URO17™ is a simple, inexpensive urinary biomarker that has tremendous potential in point-of-service testing for patients with suspected urothelial carcinoma. I have found it to be a significant upgrade over traditional cytology in the detection of both high and low grade urothelial carcinoma. In my experience, a negative URO17™ is extremely meaningful and reliable in triaging patients away from invasive procedures. Furthermore, URO17™ has been able to adjudicate indeterminate cytology results and allow me to better tailor surveillance schedules in patients with a history of bladder cancer.”

– Tom Jayram MD
Director, Advanced Therapeutics Center
Urology Associates, P.C. Nashville, TN