John A. Prendergass, associate director of digital health at Ben Franklin Technology Partners, who invests in medical device start-ups, said he was concerned by the high costs, false negatives and low sensitivity of the tests he had looked at.
“The entire diagnostic test space is trying to solve these issues,” he said. “That said, we know one day they are going to be a major component of health care not only in America, but all over the world.”
These diagnostics have little in common with those once promoted by Theranos, the blood-testing company that promised to rapidly diagnose a host of infections through a finger prick, but which turned out to be colossal fraud. Unlike Theranos, which was highly secretive about its technology, the mechanics of these new diagnostics are well understood, and many of the tests are already being road-tested by hospitals across the country as they wait final clearance from the F.D.A.
In addition to saving lives, the new tests could also ameliorate the growing crisis of drug-resistant infections, because pinpointing infections quickly would show doctors which antibiotic to use, rather than resorting to the shot-in-the dark dispensing of broad-spectrum antibiotics for patients with hard to diagnose infections.
Broad-spectrum antibiotics that act on a wide array of bacteria are commonly used in emergency rooms and intensive care units to combat bloodstream infections, or sepsis, which kill 270,000 Americans a year, accounting for a third of all hospital deaths. Septic shock is also quick to kill, with mortality increasing 8 percent each hour an infection goes untreated.
But at least half of all antibiotics are wrongly prescribed, researchers have found, and some studies suggest that a third of antibiotics prescribed by doctors are unnecessary, many of them dispensed without having a diagnosed infection. Such overuse is one of the major causes of mounting antibiotic resistance as germs mutate to survive.
“We believe patients should be treated based on what they’re infected with, not what doctors think they might have,” said Tom Lowery, the chief scientific officer of T2 Biosystems, a Boston company whose bacteria panel test has been the first to pass muster with the Food and Drug Administration and the Centers for Medicare & Medicaid Services.