Mar. 20, 2007 — The U.S. Food and Drug Administration (FDA) has cleared for marketing Cepheid‘s MEMS-based Xpert EV, a test that uses molecular biology to quickly detect the presence of viral meningitis. The Xpert EV, when used in combination with other laboratory tests, promises to help physicians distinguish between viral meningitis and the less-common, but more severe version of meningitis caused by bacteria.

Meningitis is diagnosed by testing the fluid obtained from a patient during a spinal tap. Typically, diagnostic tests for meningitis can take up to a week to get results. But results from the Xpert EV test are available in two and one-half hours.

Bacterial meningitis can be deadly within two days. “Because this test is significantly faster than existing methods for diagnosing meningitis, it could minimize delays in treating patients. Swift recognition of the cause and appropriate treatment is critical to patient recovery,” said Daniel Schultz, M.D., director of the Center for Devices and Radiological Health.

Knowing whether the meningitis is viral or bacterial is imperative to early effective treatment. But distinguishing between the two types of infection has been difficult because of similar symptoms. Patients with viral meningitis usually recover within two weeks without any medical intervention. Bacterial meningitis, however, can lead to brain damage, hearing loss and even death if not treated properly.