Skip to main content

Cepheid Launches CE Marked Bladder Cancer Test

NEW YORK (GenomeWeb) – Cepheid has launched a CE marked bladder cancer test that is currently commercially available in Germany and will launch throughout Europe in the coming months.

The Xpert Bladder Cancer Monitor test runs on the firm's GeneXpert molecular diagnostics system. It has about a 94 percent negative predictive value, so could be particularly useful in more confidently ruling out bladder cancer and reducing the need for more invasive testing, Cepheid said.

The test "delivers accurate results noninvasively in just 90 minutes, which may improve compliance in patients being monitored for bladder cancer recurrence," David Persing, Cepheid's chief medical and technology officer, said in a statement.

Overall sensitivity for the test is 75 percent, with a sensitivity for high-grade tumors of 84 percent, and overall specificity of about 81 percent, the firm said.

Bladder cancer affects over 150,000 patients annually in Europe and is the fifth most common cancer. It is also among the most expensive cancers on a cost-per-treatment basis, Cepheid noted.

"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," said Persing.