New Meningitis Test Gets OK From Feds
Monday, March 19th, 2007WASHINGTON (AP) — A test to help doctors rapidly distinguish between viral meningitis and less common but more severe spinal cord and brain infections caused by bacteria received federal approval Friday.
The Xpert EV test can give meningitis test results in 2 1/2 hours, or far less than the week it can now take, the Food and Drug Administration said. Sunnyvale, Calif.-based Cepheid developed the test and the company’s shares jumped 78 cents, or 9 percent, to $9.44 on the Nasdaq Stock Market.
Meningitis is an infection of the fluid surrounding the spinal cord and brain. The newly approved test, when used in combination with other laboratory tests, can distinguish between viral and bacterial meningitis. That can minimize delays in treating patients, the FDA said.
Bacterial meningitis can lead to brain damage, hearing loss and even death if not treated. Patients with viral meningitis can recover on their own within two weeks - yet often are treated, ultimately unnecessarily, with antibiotics as a safeguard against bacterial meningitis, the FDA said.