Sepsis is a dangerous bloodstream infection, one that can develop from even a minor cut yet lead to organ failure and death. It accounts for about 1.6 million hospitalizations a year (about 4,600 patients every day). Add to that a mortality rate of between 20 and 50 percent, and the FDA s approval of a new device for making more rapid and accurate identification of such bacterial infections seems like very good news indeed.
The newly approved device, developed by Nanosphere, Inc., is called the Verigene Gram-positive Blood Culture Nucleic Acid Test. Instead of the two-to-three days typically required for specific results to be obtained from a conventional blood culture panel, the device is able to identify bacterial strains responsible for septicemia (bacteria in the blood) within just three hours, as well as to determine which antibiotics will be effective against the pathogen in question.
The FDA approval was based on a study of 1,642 patient blood samples that compared conventional testing methods with the Verigene device and found that the new device s accuracy ranged from 93 to 100 percent. That accuracy, and the speed with which the device dispatches it, is critical. Too often, when a patient shows signs of sepsis, such as fever, low blood pressure, and a racing heartbeat, it can be difficult for doctors to distinguish it from other conditions. Yet because of the delay in diagnosis, treatment may come too late. And countering the unknown with immediate treatment of broad-spectrum antibiotics may just be futile when the infection is due to a resistant bacterial strain.
The Verigene device currently costs between $50,000 and $100,000, and a high-traffic lab might need as many as four. However, the president of Nanosphere estimates that it could significantly reduce the current $20,000 cost of a single conventional sepsis workup.
ACSH's Dr. Josh Bloom is impressed with the device s apparent capabilities, which he regards as significant breakthroughs. Being able to identify these bacteria quickly and accurately will provide significant guidance to physicians who have had to decide on treatments based on minimal knowledge of the pathogen," he says, "since a normal bacterial culture takes about two days.