Cepheid, a maker of genetic-screening technology, won U.S. regulatory approval to sell the first rapid test for viral meningitis.
The Food and Drug Administration approved Cepheid’s Xpert EV test to help doctors distinguish viral meningitis from more dangerous bacterial infections within 2 1/2 hours, the agency said Friday in an e-mailed statement. Hospitals often wait days to get results of a culture screening from a lab.
The differences
Patients usually recover from viral meningitis within 10 days, while rare bacterial cases can cause brain damage, stroke or even death if they aren’t caught and treated early. Cepheid says hospitals could save $7,400 on average for every patient with symptoms of meningitis by more quickly ruling out bacterial infections and sparing unneeded hospitalizations and medication.
“You have a much better idea of what you’re dealing with,” John Bishop, chief executive of Sunnyvale-based Cepheid, said in a Feb. 15 telephone interview.
Meningitis is an infection that can cause inflammation of the membranes surrounding the brain and spinal cord. About 25,000 to 50,000 people with viral meningitis are hospitalized each year in the United States, according to the Centers for Disease Control and Prevention. About 8,600 people a year get pneumococcal or meningococcal meningitis, the two most common bacteria-borne types of the infection, according to the National Institute of Neurological Disorders and Stroke.
Cepheid plans to charge $69 for each Xpert EV test. The product, which requires a sample of fluid from the patient’s brain or spinal cord, has been tested in children and adults. Bishop estimated the potential value of the U.S. market for rapid meningitis tests at $60 million to $65 million a year.
Other contracts
The company won a $2.4 million contract from the U.S. government in December to develop a rapid screening test for a potentially fatal strain of avian influenza using the same technology as the meningitis test. Cepheid was cleared by the FDA in July to sell a rapid test for a type of strep infection that sickens newborns, pregnant women and the elderly.
Shares of Cepheid rose 78 cents, or 9 percent, to $9.94 in Nasdaq Stock Market composite trading.