The Xpert bladder cancer monitor from Cepheid, Sunnyvale, Calif, is now commercially available in Germany and cleared for commercial availability in all countries accepting the CE mark.
Bladder cancer is the fifth most common cancer in Europe, affecting more than 150,000 patients annually. It is also among the most expensive cancers on a cost-per-treatment basis, in part due to high recurrence rates and invasive surveillance strategies.1,2,3
The newly available Xpert bladder cancer monitor is designed to provide up-to-date information on cancer recurrence for bladder cancer patients, using a noninvasive urine specimen. The test has an overall negative predictive value of 93.9%, providing urologists with actionable results to more confidently manage their patients’ risk of recurrence, and potentially reducing the need for frequent invasive testing.
“Xpert bladder cancer monitor delivers accurate results noninvasively in just 90 minutes, which may improve compliance in patients being monitored for bladder cancer recurrence,” says David H. Persing, MD, PhD, chief medical and technology officer at Cepheid. “We believe the test will also likely improve workflow management for urologists and their bladder cancer patients, because it provides same-day, clinically actionable results that inform important downstream management decisions.”
“Bladder cancer continues to have the highest lifetime treatment costs per patient out of all of the cancers and—with a rising population—those costs will continue to add up,” says Maximilian Burger of the department of urology at the University of Regensburg. “Bladder cancer continuously demands treatment decisions that can impact outcomes and quality of life. Guidance tools tailored to patient management fill this unmet need.”
The Xpert bladder cancer monitor features an overall sensitivity of 75%, sensitivity for high-grade tumors of 84%, and overall specificity of 80.6%. The new test is available immediately in Germany, and will launch throughout Europe in the coming months.
For more information, visit Cepheid.
REFERENCES
- EUCAN bladder cancer fact sheet [online]. Lyon, France: International Agency for Research on Cancer, 2012. Available at: http://eco.iarc.fr/eucan/Cancer.aspx?Cancer=32. Accessed December 7, 2016.
- Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013;49(6):1374–1403; doi: 10.1016/j.ejca.2012.12.027.
- Svatek RS, Hollenbeck BK, Holmäng S, et al. The economics of bladder cancer: costs and considerations of caring for this disease. Eur Urol. 2014;66(2):253–262; doi: 10.1016/j.eururo.2014.01.006.
