Bloodstream infection detection test approved for marketing

In a first of its kind, the FDA has approved the marketing of the PhenoTest BC Kit, which is the first test to identify organisms that cause bloodstream infections. The test kit, manufactured by Accelerate Diagnostics Inc., can provide information to health professionals about which antibiotics the organism is sensitive to and potentially reduce the amount of time to provide this information. As a result, antibiotic treatment recommendations can be formulated much quicker. Unlike traditional identification and antibiotic susceptibility tests that may take 24 to 48 hours after detection in a positive blood culture to provide test results, the PhenoTest BC Kit can identify bacteria or yeast from a positive blood culture in approximately 1.5 hours. The test can identify 14 different species of bacteria and two species of yeast that cause bloodstream infections, while also providing antibiotic sensitivity information on 18 selected antibiotics for a subset of the identified organisms as appropriate.

Bacterial or yeast blood infections can occur in individuals of all ages, but are particularly severe in infants, the elderly, and those with weakened immune systems. If not treated rapidly, such bloodstream infections can lead to severe complications, such as septic shock and death. The PhenoTest BC Kit can also provide treatment recommendations within 6.5 hours of organism detection in blood cultuers.

The FDA reviewed the data for the PhenoTest BC Kit through its de novo premarket review pathway, a regulatory pathway for devices of a new type with low-to-moderate-risk that are not substantially equivalent to an already legally marketed device and for which special controls can be developed, in addition to general controls, to provide a reasonable assurance of safety and effectiveness of the devices. Although some risks with the kit included false positive findings, the FDA’s decision was based on Accerlerate’s clinical study of 1,850 positive blood cultures.  In the study, bacteria or yeast in positive blood culture was identified correctly more than 95 percent of the time.