Trek tests for antibiotic resistance--and stays in Northeast Ohio

An attractive young woman walked up to Mike Burke at a trade show a while ago. She handed him a slick magazine about RTP and invited him to come down—free of charge—to visit Research Triangle and see if he didn’t want to move his company down there. Burke, CEO of Trek Diagnostics Systems, Inc. wasn’t up for it, but they keep sending him this magazine.

Meanwhile Trek Diagnostics is busy making news, winning awards and developing new technologies, instrumentation and workflows for testing for antibiotic resistance. One of their latest is for testing blood culture—one of the most critical tests in the microbiology lab. The blood must be sterile, and morbidity (sickness) rates are high.

Many physicians put patients on drug therapy as a precaution, but with a culture you can identify that there is in fact a blood-borne pathogen. Then after you grow it in a culture bottle, you test further to see what drugs are most effective against it. The Trek test is about speed, getting positive results, and confirming the proper treatment as soon as possible to prevent using resistant antibiotic.

Trek invents and markets the software, the hardware and the background technology—users just want to know what’s available and to have tests that are easy to use

Trek has been wholly funded through equity and banking—never used any venture capital. “We were lucky that our volumes of existing products generated enough cash flow to warrant the financing,” says Burke. All product development is done in Trek labs and with an engineering firm they use. They collaborate with Hillcrest and the Clinic for workflow advice and design advice. “They’re very willing to support us by reviewing our ideas and the workflow designs we propose,” he says. “It’s a symbiotic relationship.”

Trek has undergone rather dramatic changes since it was founded as a small division of another company with 95 employees in 1999. From a fledgling organization fighting to maintain share, they’ve now achieved a very competitive position and employ 160 people. They recently won an award from an In Vitro Diagnostics organization that publishes a review, IVD Technology.

“Our products, people, and processes put us on a growth curve,” says Burke. “We’re very fortunate we have some real supporters here.” They hire med-techs from Cleveland Clinic Foundation as they added staff.

Molecular testing next

Technologies for traditional microbio testing haven’t changed significantly yet, but new testing is being developed at the molecular level that complements what’s been being done in the lab. “Molecular testing is generally faster and more accurate, but it’s not as broad, “says Burke. “For example, there’s no molecular test that can accurately read blood cultures like ours.”

Bacteria in the blood are not homogeneous, and when you draw blood, it’s easy to end up not capturing the blood going past the needle. For accurately capturing bacteria, you need larger samples 20 ml, but the test can only work with minute specimens. So you need to place it in a blood culture bottle (10 ml in aerobic and in anaerobic bottles), then grow it and detect it. Burke says molecular testing will not replace that part any time soon, but once you grow it, you can take a piece from the mass of bacteria and run a molecular test on it.

Molecular testing can tell you what the pathogen is, but it’s not good at determining resistance, according to Burke. Trek is looking at partnering with some molecular testing companies, molecular manufacturing companies, not doing it themselves. From Trek's point of view, this as an ideal type of company to attract--and would serve Northeast Ohio well for the long run.

“Molecular is the future in many areas of science,” says Burke. “I’ve heard it said that metals or building materials as we know them have been restricted by physics of the material. But at the molecular level we can get around physics by designing new materials molecularly—nanotech is an example.” New materials, not bound by physics, will be much stronger than steel or other known materials. Burke expects we will see an explosion of these materials in the next 50 years.

How’s Cleveland for resources? Burke says the work ethic is strong here. “We rely on UH and CCF and Metro to help us with certain positions, but for non-science areas, the educational level of the people here is good.”

To become a bioscience/tech hub, Burke says Northeast Ohio needs to start with dedicated organization. “Part of the Greater Cleveland Partnership or a separate funded organization like NEOBio.” Rather than trying to bring any and everything in, Burke says it make sense to build on existing areas of expertise: cardiology, orthopedics, etc. “Companies in those areas could use our institutions to leverage getting some of the R&D done here. They could develop divisions here. That’s how it’s being done in North Carolina. A lot of companies have located divisions there. Not startups or incubators; they’ve located large manufacturing divisions in these areas.”
Burke suggests the area should be specific about the types of companies it wants to attract.

Grassroots work turns into NEOBio

The attitude of the press is critical to the success of any community-building venture, says Steve Goldberg, executive director of NEOBio. At last, he says, economic development people are beginning to realize how important the bioscences are to their work.

“We need to say what we’re doing [at NEOBio],” says Goldberg. “After a year, it’s working. Companies, associations, hospitals, government are buzzing about us. And we have to stop being secretive about funding, and so on.”

“When the press doesn’t support those efforts, it’s tough.”

How it started

It all started when Goldberg was networking for his consulting business and ran into someone in the industry who had an IT problem. Then, in the same room, same event, same hour, he saw another guy in the industry and asked him if he knew the other guy. “I grabbed him and dragged him across the room—turned out they had the same problem. I said, why don’t you guys collaborate?”

Goldberg had a similar conversation with Bob Schmidt of Cleveland Medical Devices. And then, he says, it became an unstoppable force. CWRU got on board and then, after 5 weeks of meetings, the concept took shape.

NEOBio is not meant to be a real organization, according to Goldberg. “It’s meant to facilitate a healthy, organic, self-sufficient bioscience community.” Starting with 6 member companies and 4 others interested, the group now has 37 companies after one year. Recruitment efforts took place at community events Goldberg organized. The group built a database using the social networking model—names on the list have been gathered organically rather than by purchasing any SIC-code-constructed lists. The list so far includes 222 pure bioscience companies and 74 related (consultants, providers, contract manufacturers). “It’s real It’s up-to-the-minute,” he says.

Bioscience impact in Ohio

Impact means money and jobs—taxes, payroll, head counts for employees in the industry. A 2001 Battelle study claimed there were 7100 people employed in the biosciences in Ohio—that’s half of all the jobs in the state of Ohio. “A lot’s been going on since 2001, says Goldberg. “We estimate half a billion dollars in payroll now. And when you add researchers and health care workers in our large institutions, that number explodes.”

Grant money is essential, says Goldberg, but he notes that only a small percentage of it actually goes to the people doing the jobs. NEOBio will soon be applying to the Civic Innovation Lab for a second round of funding. The organization started with funding in early 2004. “Now there are a lot of well-respected people in this area interested,” he says, but he’s a little concerned at the push to formalize the organization even further. “I reject the idea that we know what we are doing—that we can predict where we’ll be at any given moment, let alone 5 years from now.”

“Fred Rothstein, CEO of University Hospitals, says we are already doing clinical trial work here for the big companies,” says Goldberg. He says it would be even better be if those companies would set up satellite offices here and hire people in Cleveland—say, engineers to tinker with their projects.

“We have to start paying attention to the real successes in our area—when a company like Cleveland Medical Devices owns a building and employs 35 people, it’s worth recognizing.” Goldberg talks about the need to fight  constrictive legislation such as the law that now gives companies only 5 years of patent protection—instead of 17—in which to sell their creations at free market prices. “Bioscience companies pay for all the development time, all the field efforts, then they only have protection for a short while. It makes no sense.”

Goldberg says NEOBio’s goal is to connect everyone in this industry and not have them rely on any institution. Businesses should be taking an active part in the connecting part. “If you’re too busy running your business,” he says, “you’re not doing all you can to keep the environment friendly for its continued success.”

Building relationships helps people make the connections that facilitate combining areas of interest…sometimes resulting in coming up with a new blockbuster idea. Goldberg mentions Pittsburgh and Ann Arbor. “They’re paying attention,” he say. “Pittsburgh Life Science has a networking event once a quarter that some of us plan to attend.”

The structure of NEOBio has to be flexible, according to Goldberg. It must be able to “respond to serendipity.” He believes in the possibilities that arise “when you don’t do everything the old way.” It’s about helping companies do for themselves. “We are grassroots,” says Goldberg. “We don’t rely on professionals [non-profit people].”

Besides being director of NEOBio, Goldberg is also part of a bioscience consulting startup called Synventus. Check out http://www.neobio.org/ and http://www.synventus.com/