(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, included a late-breaking oncology abstract session, where Dr. Hideki Furuya presented a study exploring the diagnostic accuracy of Oncuria-Detect for upper tract urothelial cancers.
To begin, Dr. Furuya reviewed current strategies in diagnosing upper tract urothelial carcinoma (UTUC), including urine cytology, voided and selective, imaging with ultrasound, CT, MRI, and PET, and cystoscopy with ureteroscopy. However, he underscored the unique challenges in accurate grading and staging given the limitations of these techniques.
Onicuria® is a urine-based, multiplex immunoassay that measures 10 biomarkers, angiogenin (ANG), apolipoprotein E (APOE), alpha-1 antitrypsin (A1AT), carbonic anhydrase 9 (CA9), interleukin-8 (IL-8), matrix metallopeptidase 9 (MMP9), matrix metallopeptidase 10 (MMP10), plasminogen activator inhibitor 1 (PAI1), syndecan 1 (SDC1), and vascular endothelial growth factor (VEGF), all associated with bladder cancer. Onicuria® has three distinct tests to be used in the following clinical settings: Onicuria® Detect, for patients with hematuria, Onicuria® Monitor, for patients with a history of bladder cancer on surveillance, and Onicuria® Predict, to evaluate potential response to BCG. This study explored the utility of Onicuria® Detect in UTUC detection.
He then reviewed the phased development of the test:
Next, Dr. Furuya reviewed the results within the UTUC cohort. Oncuria™ Detect provided an AUC of 0.897 (95% CI: 0.817-0.977). The sensitivity of the test was 93.5%, while specificity was 75.6% (NPV 93.9% and PPV 74.4%). Sensitivity values of the diagnostic panel for high-grade UTUC, low-grade UTUC, non-invasive UTUC and invasive UTUC were 88.9%, 92.3%, 86.7% and 100%, respectively.
Within the cohort, urine cytology or selective ureteral cytology was associated with a sensitivity of 58.3%, specificity of 100%, NPV 79.2% and PPV 100%. Sensitivity of cytology for high-grade UTUC, low-grade UTUC, non-invasive UTUC and invasive UTUC were 50%, 100%, 80% and 42.9%, respectively.
Dr. Furuya concluded his presentation by noting the following:
- Oncuria™ Detect allowed accurate discrimination of UTUC and non-tumor bearing controls
- The test can achieve efficient and accurate detection of UTUC, even in a non-invasive setting
Presented by: Hideki Furuya, MD, PhD, Cedars Sinai Medical Center, Los Angeles, CA
Written by: Ruchika Talwar, MD, Urologic Oncology Fellow, Vanderbilt University Medical Center, during the 2023 American Urological Association (AUA) Annual Meeting, Chicago, IL, April 27 – May 1, 2023