EP Inventor Is Shortening the Time to Identify Pathogens

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With every minute mattering in emergency medicine, Brett Etchebarne is fighting for more time—and winning. An assistant professor of emergency medicine in the College of Osteopathic Medicine at Michigan State University, he has developed a way to identify pathogens much faster than usual, reducing days to mere hours. Two or less, in fact.

Utilizing his background in functional genomics in animal systems and entrepreneurial stem cell medicine, Etchebarne has created a molecular diagnostic system that quickly determines whether a patient sample (blood, urine, spit, wound, stool, or cerebral spine fluid) contains dangerous bacteria such as E. coli, Staphylococcus, and some superbugs. The point-of-care test known as In-Dx is already more than a year into clinical trials and shows plenty of potential to greatly improve antibiotic stewardship.

Etchebarne was 33 and in his fourth year of med school when he came up with the idea. He was interested in all angles of medicine, but chose emergency medicine because as he says, “I just want all the answers, and I want them quickly.” Much of his motivation comes from recognizing that multiple antibiotics are prescribed because physicians don’t know what infection they’re dealing with until days after treatment and patients were rapidly deteriorating, particularly with sepsis. “I saw that it took a number of days before you knew what you were actually combatting, so that was an obvious detriment,” he said. Plus, “Empirical medicine is just way, way weaker than prescriptive medicine in my opinion.”

Etchebarne’s residency was tailored around this project, and MSU provided research start-up money in addition to plenty of mentoring influences. Now, six years after inception, Etchebarne holds one patent for the test and MSU holds another. His team processes quite a lot of samples and recently submitted results to the Journal of Clinical Microbiology. “We’re moving forward with bringing our testing to the forefront of medical practice,” he said.

While labs can take days to produce results, in just an hour or so, In-Dx has correctly identified 85% of the exact bacteria from about 300 samples it has tested. Moreover, the process is remarkably simple.  A sample is collected and concentrated into a smaller amount. After applying heat, which breaks down the sample cells, it’s then placed into the In-Dx testing panel and after 20 minutes of incubation time, the positive sample changes color, revealing the invading organism.

“I’ve always wanted my tool to be something that I can use anywhere, whether I’m in a super high tech level one trauma center somewhere or in the middle of nowhere,” Etchebarne says. “So to address that aspect, you look towards less of a quantitative analysis with outputs on Excel sheets and whatnot, but just the qualitative analysis.”

Much of the innovation lies in the primers themselves and in the methodology used for the extraction of the clinical samples. Etchebarne explains the system’s two prong approach. “To do our testing, we employ a Thermal Cycler PCR machine. A Roche LightCycler is what it’s called. It’s a 96 well plate format,” he said. “That way we can basically get a realistic handle or scientific handle on what our results look like and compare against hospital culture results.” The PCR machine detects and records changes in fluorescence with computer generated readouts, and a simple hot plate allows for visual discrimination of color change from purple to blue without involvement of computers. The indicator dye used, Area Chrome Black, has been used for other scientific investigations but not with this sort of methodology. “It doesn’t require any special technologies or equipment so to speak to arrive at your answer,” he said.

He also found ways to simplify procedures and reduce costs.  “I found unnecessary reagents as well as steps requiring separation of reagents, which did not add value to reactions were commonly used in direct amplification protocols. Their removal clearly decreases costs, as nothing is free. Condensing steps in reactions helps save processing time. All together reactions became simpler and cheaper.”

More recently, Etchebarne’s team has made reaction mixtures that are stable at room temperature for long periods of time to allow for transport of materials to be used within a time frame of greater than one month. Previously, everything was prepared fresh to run reactions. “So now we have the ability to store materials and use them when they are needed without preparing everything fresh each time,” he said. “This saves time and reduces a huge potential source of error from the experiments.”

It isn’t hard to imagine the kind of patient who would benefit most from Etchebarne’s invention. “The elderly population stand to benefit a lot because it’s way easier to say grandma’s got an E. coli infection than her dementia is getting worse,” Etchebarne said. Though he hasn’t targeted the neonatal population due to consent and other issues, the neonatal population might benefit the most, as infants will die pretty fast with a staph infection or other nasty disease. “I don’t have any kids in my study. But in the future, I would say somebody will probably take that on in some ICU setting or something,” he said.

While In-DX is still in development, it’s showing remarkable potential compared to traditional labs. “We are better at detecting things that the hospital doesn’t seem to see. They might get a primary pathogen but miss a secondary one, which by our analysis looks to be there in virtually identical concentrations,” Etchebarne said. Getting funding and FDA approval is the next big hurdle. “FDA approval is pretty expensive, and you have to have associated clinical laboratories that are already CLIA certified, that already have all of the pieces in place for getting the testing done,” he said.

Would Etchebarne consider going into business, full time, and leaving clinical practice behind? “Oh, I don’t know. I love the ER because it’s like the realest of real things…If you step away from being a clinical practitioner for too long, your skills will become rusty rather quickly, I would imagine,” he says. “I hope to get the technology out to as many people as possible because it does not hurt them and can only help them. Helping others in the end will be far more rewarding than lining my pockets!”

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