Infection Fighters

Hand-held detection device puts a pair of Wayne State doctors on the verge of a major medical breakthrough.

It’s no secret Detroit attracts inventors determined to turn innovation into reality. But here’s something not as well known: Dr. Greg Auner and Dr. Charles Shanley have quietly been inventing at the Wayne State University School of Medicine — a decade-long collaboration that’s led to some 30 patents.

Pretty impressive output from professors Auner (biomedical engineering) and Shanley (surgery).

But the process was also frustrating, creating what Shanley describes as a “translation gap” between the  lab and tangible applications. In 2011, the two formed the company Medical Engineering Partners to translate their high-tech devices into clinical practice.

Now they’re on the verge of a major breakthrough with Seraspec, an invention that could soon be the world’s first real-time, hand-held pathogen detection and identification device. Real-time detection hasn’t been possible until now. Typically, a culture needs to be taken, then sent to a lab for analysis. It can be a matter of days, at least, before bacteria, infection, or virus can be identified.

Timing can be crucial when dealing with something like a potential pandemic, such as Ebola. But the Seraspec can quickly discern the difference between a deadly virus and, say, a really bad cold. It could also be used to identify drugs, toxins, or chemicals that might result from industrial spills, radiation from a nuclear accident — or even bioterrorism.

“When you talk about vexing clinical problems, infection is often the final kind of pathway that people succumb to,” Shanley says. “To treat any infection properly and safely requires that you know what you’re treating. Otherwise you kind of take a shotgun approach, throw the kitchen sink at it, and hope that it covers it.”

That approach poses a litany of problems, not least of which is the time required to make a definitive diagnosis through a sample or culture.

“That process takes hours at a minimum, and for most cultures it takes days,” Shanley says. It also involves large, expensive, and complex technology.

The Seraspec has its origins in something called Raman spectroscopy, a technique utilizing a laser beam to provide a molecular fingerprint that can identify a particular organism.

The Raman microscope in Auner’s lab on the third floor of WSU’s College of Engineering is a refrigerator-sized mass of metal, tubes, and wires. A technician sits in the middle of it all, reading images on a screen and typing into a keyboard.

“It costs nearly $300,000,” Auner says, “and if she bumped it, it would go out of line. Plus, you need a Ph.D. to operate it. What we did is shrink that down and create a device that’s a thousand times faster, simpler, much more sensitive, and all solid state…you could drop it and it would still work.”

MEP developed two prototypes of the Seraspec. One will have a port for analyzing biological fluids. The other will feature a hand-held probe, similar to an otoscope used by physicians for ear examinations. Both will be automated and provide immediate results at the point of care.

“Imagine out in the fields of west Africa, where Ebola might be spreading,” says MEP COO Mark Trexler. “You need to quickly test hundreds of people to mitigate or track where the spread is taking place, and instantly tell if it’s a virus or bacteria.”

And by instantly, he means precisely that. Analysis of the molecular “fingerprint” starts within milliseconds, then it’s compared to a library of signatures and a diagnosis is delivered. MEP has developed signatures for many important bacteria and pandemic viruses and continue to expand their library.

MEP is working toward approval by the Food and Drug Administration. This year, they’re hoping to launch the device in the veterinary market, where the FDA stamp is not needed.

Meanwhile, they’re collaborating with governmental agencies.“We believe we can demonstrate that this not only adds value but potentially solves some of their biggest problems,” Shanley says, “like how are we going to deal with the next viral pandemic, or the next Ebola, or anthrax?”

As the testing continues, so does the quest for capital. MEP initially raised $200,000, with half coming from Paul Glantz, the founder and chairman of Novi-based Emagine Entertainment. Recent “angel” investors have boosted the tally to $1.3 million.

“It’s a challenge when you have a disruptive technology like this, because you can’t just come in with a napkin drawing,” Shanley explains. “You’re saying you’re going to displace all this other stuff, and they say, ‘I want to see this baby work!’ ”

Ultimately, the partners hope the Seraspec will become essential equipment. And that can’t happen soon enough. “My goal as a clinician,” Shanley says, “is to get this in the hands of clinicians.”

Meanwhile, the team is fine with working under a shroud of anonymity. “We prefer to stay low key and take the ‘crawl before we run’ approach,” Trexler says. “We have a long road still ahead.”