Accelerate Diagnostics earned 510(k) clearance for a test that identifies the organism behind bloodstream infections and provides information about its antibiotic sensitivity.
The PhenoTest BC Kit, which runs on the company’s Pheno System, is the first test to identify the bacteria or yeast behind a blood infection and supply information about which antibiotics it is likely to respond to, the FDA said in a statement.
It identifies 14 species of bacteria and two species of yeast and provides antibiotic sensitivity information on 18 antibiotics, the FDA said. The test works by comparing the DNA of the infection-causing bacteria or yeast to DNA that is unique to specific organisms. The organism is then mixed with different antibiotics to determine which ones curb the organism’s growth.
Identification takes about an hour and a half, while antibiotic sensitivity information may be generated in as few as six and a half hours, according to the statement. Existing antibiotic susceptibility tests may take 24 to 48 hours to return results, the FDA said.
"By identifying organisms and knowing earlier which antibiotics the organism is likely to respond to, health care professionals can treat patients with bloodstream infections more appropriately," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health.
Bloodstream infections are particularly dangerous in infants, the elderly and those with compromised immune function. Rapid identification of appropriate antibiotics can lead to early intervention to head off complications, such as septic shock.