One of the most frustrating aspects of going to the doctor’s office is waiting for the lab results to come in – and knowing that there often isn’t much the doctor can do to treat you until those results are ready.
Middleton-based Lucigen Corp. is trying to take away the hassle of waiting for lab results – at least in the case of infectious diseases – through the development of an innovative point-of-care diagnostic platform. In other words, instead of sending a patient to the lab and waiting for up to two days for results, a doctor or nurse could administer a test in the office and get the results in about a half hour.
Lucigen was at the 2014 BIO International Convention in San Diego in late June to educate other companies on its unique diagnostic platform with the goal of seeking partners to help commercialize the product. The company, part of the Wisconsin delegation, had more than 30 “partnering” meetings with companies from around the world as it looks for partnership opportunities.
“All the meetings we have are related to the diagnostic platform – describing what it is, and how a company might be interested in how that technology could help whatever that company they’re working on,” said Curtis Knox, vice president of marketing and sales. “The platform is actually pretty flexible and can be used for human molecular diagnostics or animal diagnostics, any kind of infectious disease diagnostics or where you need to detect particular organisms, bacteria or viruses.”
The company hopes to change the way infectious disease diagnostics are performed with its fast, economical testing platform that still achieves the superior sensitivity and specificity of laboratory-based molecular diagnostics.
“The whole idea is having the diagnostic test and the next step in which the patient gets better all in the same visit,” said Hemanth Shenoi, Lucigen’s director of business development. “Let’s say you go to the doctor and you think you have the flu. You get a test in the physician’s office and by end of that visit, you know if you truly have the flu or if it’s just a cold, and you’re now able to immediately begin treatment. If it is the flu, you’re going to get different medicines. If it’s the common cold, they’ll tell you to get grandma’s chicken soup.”
Not only will that be more convenient for the patient and doctor, but the new testing platform has the potential to reduce health care costs as well, Knox and Shenoi said.
Take, for example, the current procedure for testing for Clostridium difficile (C. diff), a bacterial infection that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon.
“When someone comes to the hospital with a potential C. diff infection, they’re most likely to immediately quarantine that person, take a sample and then send that sample out for testing, which will take 24 hours or longer to get a definitive test back,” Knox said. “In the meantime, you’ve got hospitalization of that patient for the entire time at a cost of $2,000 a day.
“What we’re trying to do is bring a test that has that same level of sensitivity that a major lab molecular diagnostic test would provide, but turn that into a 30-minute test, where it can be done at the point of care. The patient can sit there for a half hour, get that same definitive test back, and if they’re negative, you’ve completely avoided that day of hospitalization at significant cost savings.”
Lucigen is finishing up on product development and is starting to plan for its clinical trial, which should start in early 2015. Once those results are in, the company plans to present those findings to the U.S. Food and Drug Administration for approval.
“When it comes to infectious diseases, you’re sick and want to get better,” Shenoi said. “Timeliness is of value to the physician, and it’s valuable to the patient because they want to get the outcome as quickly as possible.”
Mark Maley is the public information manager at the Wisconsin Economic Development Corp.