FDA approves test for quicker detection of hospital ‘superbugs’

The Food and Drug Administration (FDA) has given a thumbs up to a test hospitals can use to identify certain types of antibiotic-resistant infections more quickly.

The test, developed by Sunnyvale, Calif.-based Cepheid, is the first of its kind to be cleared by the FDA.

The Cephid test uses rectal swabs, rather than the current method of growing bacteria from fecal matter in cultures, and then undergoing antimicrobial susceptibility testing.  The swab specimens can be more quickly tested for genetic markers associated with Carbapenem-resistant Enterobacteriaceae (CRE).

“The number of global incidents associated with these deadly bacteria is surging, and is frequently associated with high morbidity and mortality, in addition to increased hospital costs," David Persing, MD, PhD, Cepheid's Chief Medical and Technology Officer, said in a statement. "Xpert Carba-R delivers a highly accurate result in as little as 48 minutes.”

In contrast, testing bacterial cultures may take up to four days.

The hope is hospitals can use the test to quickly identify patients with CRE and place them into isolation to prevent the spread of the antibiotic-resistant infection throughout the facility.

“By using a specimen taken directly from a patient to test for the presence of genetic markers, hospitals can more quickly identify these dangerous bacteria resistant to certain antibiotics,” Alberto Gutierrez, MD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement.

The FDA said hospitals should continue performing the bacterial culture testing along with using the new method.

The approval follows other recent efforts by health agencies to prevent the spread of antibiotic-resistant infections in hospitals. The Centers for Disease Control and Prevention (CDC) recently announced $26 million in funding for research to expand and improve prevention efforts.