Cepheid (CPHD) Announces Commercial Launch of Xpert Bladder Cancer Monitor in CE Mark Countries

October 5, 2016 4:08 PM EDT

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There's now an easier way to confidently rule out bladder cancer recurrence, thanks to a new test from Cepheid (Nasdaq: CPHD), Xpert Bladder Cancer Monitor, now commercially available in Germany and cleared for commercial availability in all countries accepting the CE Mark.

Bladder cancer is the 5th most common cancer in Europe, affecting over 150,000 patients annually1,2 and is among the most expensive cancers on a cost per treatment basis3, in part due to high recurrence rates and invasive surveillance strategies, including cystoscopy, that have traditionally been required to manage the condition. 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 93.9% negative predictive value, providing urologists with actionable results to more confidently risk manage their patients, potentially reducing the need for as-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," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "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," said Maximilian Burger of the Department of Urology, 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."

Xpert Bladder Cancer Monitor features an overall sensitivity of 75%, sensitivity for high grade tumors, specifically, of 84%, and an overall specificity of 80.6%. The new test is available immediately in Germany, and will launch throughout Europe in the coming months.

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