On any given day, about one in every 25 hospital patients acquires an infection.
Preventing those infections is ideal, but hospitals don’t seem to be doing a great job of that. The next best thing is detecting and treating them as early as possible.
“Everything that’s being used right now (for detection) uses either vital signs or testing blood serum or trying to do a culture, but all of that is predicated on having enough of this pathogen in you that’s it’s causing significant changes,” Joe Kremer explained.
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Kremer is CEO of a Madison, Wisconsin startup called Isomark LLC that thinks it might be able to pick up on signs of an infection within hours of the body realizing it has one using a simple breath sample.
“If you can stop an infection before it develops too far, you’re going to keep people from developing sepsis,” Kremer said.
Sepsis is a huge problem in intensive care units – NIH estimates that 28-50 percent of the 750,000 Americans who develop it each year die.
Kremer said Isomark’s test, Canary, works so much earlier because it doesn’t rely on detecting physical symptoms of an infection or an immune response. Rather, the technology is based on metabolism. Canary looks for something called an acute-phase response that occurs when the body first realizes that it’s under attack and starts gearing up to fight the pathogen.
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“Our body starts grabbing as much energy as it can, and it grabs energy from our muscles,” he said. “The breakdown of amino acids in the muscles produces a signal that we can pick up.”
It picks up that signal by measuring the ratio of two specific carbon isotopes in a person’s breath. “When an infection is present we see an increase of carbon 12 over carbon 13 in the breath,” Kremer said.
The bulk of the device is a small spectrometer that’s specifically designed to look at carbon atoms. In its current iteration, it’s too big to be placed at the patient bedside for continuous monitoring, but that’s the ultimate goal, Kremer said. After someone breathes into it, it delivers results within five minutes.
The technology behind the device was developed by a group of seven scientists at the University of Wisconsin from a variety of disciplines, from animal sciences to nutrition to chemistry to mathematics. Isomark was spun off with their research in 2005 but didn’t raise its first angel round until 2010, when it finally set its focus on the hospital-acquired infection market.
Now it’s just wrapped up a proof-of-concept trial and is getting ready to launch a 110-patient study at University of Wisconsin Hospitals and Clinics.
In the proof-of-concept study, which tracked 17 mechanically ventilated pediatric patients and 16 adults, the test was able to identify one infection two days before it was detected in clinical practice and another case 12 hours before. For the upcoming study, the company will take breath samples from participants every four hours.
To fund that study, Isomark has recently raised $150,000 from the Wisconsin Alumni Research Foundation and another $130,000 from other investors as part of a $750,000 round. It’s following the de novo pathway to FDA approval and, if all goes well, will need to conduct at least one more clinical trial involving up to 600 patients before it can go to market.
[Image credit: Flickr user Judean Peoples Front]
