On September 5, 2023 Acupath Labs reported a white paper highlighting the impressive results of a large-scale internal study analyzing the clinical utility of its Acu-UR017 bladder cancer biomarker (Press release, Acupath Laboratories, SEP 5, 2023, View Source [SID1234634917]). Acu-URO17 is a non-invasive, cost-effective urine-based biomarker used in the diagnosis and management of bladder cancer, the 6th most common form of cancer in the US. Commercially launched nationwide in 2019, Acupath has performed over 25,000 tests and has helped urology practices nationwide leverage the inherent and significant clinical and financial benefits of the assay.
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Primary positioned as a "rule out" tool, Acu-URO17 had a negative predictive value (NPV) of 99.9%, thus helping to offset the problematic low sensitivity of traditional urine cytology, while at the same time serving as a valuable risk-stratification tool on atypical urine cytology diagnoses. Further, Acu-URO17 had a sensitivity of 96% and specificity of 82% on urine cytology cases that yielded high-grade urothelial cancer diagnoses. These results are consistent with the three peer-reviewed studies that have previously been published.
"Our team has worked tirelessly over the last 4+ years to optimize this assay and make it available to clients nationwide, and these results support the significant value that Acu-URO17 provides for both clinicians and patients. We will continue working with our clients and industry partners to increase the adoption of Acu-URO17 and provide support and guidance to urology practices and labs that seek to incorporate Acu-URO17 into their existing operations.", says John Cucci, Chief Sales Officer of Acupath.
"I have seen firsthand the clinical utility provided by Acu-URO17, especially when performed in conjunction with both traditional urine cytology and FISH. This innovative biomarker has consistently demonstrated its ability to help clinicians triage patients at risk of bladder cancer and provide the best possible diagnostic and treatment plan.", says Michael Matthews, Director of Molecular Diagnostics at Acupath.
For a PDF of the white paper and / or information on how to order Acu-URO17 or incorporate into your lab, email [email protected].