San Diego, CA – In order to detect for methane and carbon monoxide, early coals miners used to send canaries down the mine shaft to check for the deadly gases. If they heard the canary tweeting, the miners knew it was safe to follow the birds into the mine.
Early detection also is the focal point of the “Canary” breath analyzer that is being developed by Madison-based Isomark LLC, part of the Wisconsin delegation at BIO 2014 Convention in San Diego this week. The device uses the patient’s breath to measure changes in carbon dioxide levels as a metabolic indicator of infections. The technology behind the Canary has the potential to save lives by catching infections before they become deadly.
“We take a breath sample from patient and put it in a special bag that measures the isotopes in carbon in exhaled carbon dioxide,” explained Dan Bütz, Isomark’s chief science officer. “When you measure the breath delta value over time, changes in the value indicate the onset of infection at the earliest possible stage of the process.
“Isomark is specifically targeting the critically ill patient at this stage who is at a high risk of developing infections,” Bütz added. “Right now we’re using it to detect hospital acquired infections, which is a huge problem in the industry.”
However, Joe Kremer, CEO of the company, predicts that ultimately the product could be used in clinics, emergency rooms, doctors’ offices and even in the home.
“We’re particularly interested in providing this to homes with older patients or younger patients,” Kremer said. “For example, if you have a small child who gets a high fever while teething – let’s say 105 – you wonder, ‘Is this something to be freaked out about, or is this something that’s OK?’
“We can actually determine that at home,” he added. “If it’s 3 in the morning, your child is spiking a fever, and we can say whether that’s a problem and you should go see your doctor, or whether there’s no need to worry about it.”
Bütz and Kremer, who are attending BIO for meetings with possible partnerships and to seek investors, note that doctors typically use a combination of vital signs to detect for an infection, usually watching for an increase in body temperature or changes in white blood cell counts.
“You can measure temperatures and the change in white cell blood cell counts rather quickly, but the problem is that they change relatively late in the disease process,” Bütz explained. “However, the blood delta value changes very early in the disease process. And that’s what affords us the extra time to catch an infection much earlier.
“Currently, the vital signs indicate the onset of a developing infection in a critically ill patient very late in the course of the disease – almost before it’s too late,” he said.
In April, Isomark received a $150,000 grant from the Wisconsin Alumni Research Foundation to help fund a pilot study of Canary, which will begin in just a few weeks at the UW Hospital and Clinics.
Kremer said that UW has been a strong partner of Isomark in all aspects of its operations.
“The UW Hospital has been very helpful, beyond what I ever expected,” he said. “They’re helping us on the medical adviser side as well as the business side and the administrative side. We have intellectual property from UW, we have a PhD from UW who helped on the technical side of the company, we have WARF that has licensed the IP back to us and have put money in, and we have this huge institution – UW Hospital and Clinics – that is helping us as well.”
After the pilot study, the next step is a critical pivotal trial, which should start by mid-2015. That trial will take about a year, and at that point, Isomark can submit its data to the federal Food and Drug Administration for approval, which should take about nine months.
It’s a time-consuming process, but Bütz and Kremer see great potential in the Canary.
“Our big vision is that one day every single person can wake up in the morning, blow into the Isomark Canary and know whether they’re infected or not,” Kremer said.
Below is a video about the business opportunities available at the conference.
Mark Maley, public information manager at Wisconsin Economic Development Corp., will be at BIO 2014 to report on the activities of Wisconsin biotech businesses. He will post regularly for BizTimes.com through the end of the convention.