FAST Diagnostics quickly is becoming one of the more promising companies in Indiana University's efforts to commercialize its discoveries.
Incorporated in November 2006, it is developing a method to measure kidney function faster and more accurately than existing techniques can. While FAST represents speed, the name actually stands for functional assessment and surveillance technology.
The fledgling firm so far has attracted more than $4 million from investors, including $2 million from the state's 21st Century Fund. BioCrossroads, Rose Hulman Ventures and the National Institutes of Health also have provided funding. Early this year, it took the top spot and $50,000 in cash and services in Purdue University's Life Sciences Business Plan Competition.
Company leaders expect to meet with U.S. Food and Drug Administration officials later this year to begin human trials.
They anticipate the two phases will finish in 2011, and estimate another $11 million to $15 million will need to be raised to complete the tests. Three years of animal studies have shown their system to be effective so far.
Jim Strickland, president of FAST Diagnostics, said it is too early to make company revenue projections, but said those involved "feel good about the way the sci- ence is coming together."
Strickland, an IU alumnus, is assisted by serial entrepreneur Joe Muldoon, who serves as CEO. Housed within IU's Emerging Technologies Center on 10th Street in Indianapolis, their charge is to get to market the technology developed by physicians Bruce Molitoris and Ruben Sandoval of the IU School of Medicine. Dr. Weiming Yu also is listed on the patent, but since has left the medical school.
Muldoon, 45, is a former president of Brightpoint Inc. who most recently served as the Indiana Venture Center's resident entrepreneur.
Strickland, 35, started his career in product development at Warsaw orthopedics manufacturer Biomet Inc. He left in 1999 to help launch DynoMed Inc., a developer of patient education software. It was acquired in December 2004 by Salt Lake City-based ChartLogic Inc.
Strickland spent a few years with the new owner in Utah before the entrepreneurial bug bit again. He started researching opportunities in Indiana in the spring of 2006 and ultimately was selected by IU's Office of Technology Transfer to commercialize Molitoris' research. Strickland, who is president of FAST Diagnostics, met Muldoon during his days at DynoMed and sought his experience.
Dr. Robert McDonald, CEO of local health care consultant Aledo Consulting Inc., assisted IU from 2005 to 2007 in identifying its most promising intellectual property. Of the 200 concepts he reviewed, FAST's method of diagnosing kidney failure was one of only four to receive his full praise.
"In places like the intensive care settings, there's really not a good way to figure out kidney function," McDonald said, "because all the tests are kind of a day late and a dollar short."
The current accepted method to detect kidney injury is to measure creatinine, a compound in the muscles and blood that is passed in urine. It typically takes 24 hours to collect the sample and an additional three to four hours to get a lab reading. In the most critically ill patients, the inaccuracy of the method increases.
The only alternative is to take a patient to a nuclear medicine facility to receive a radioactive isotope test. That's not always practical for someone in intensive care. Further, safety issues need to be considered.
FAST Diagnostics' technology uses fluorescent markers and optical sensors to measure kidney function in less than an hour. The way it works is that two molecules of different weights are injected into the bloodstream and detected by a diagnostic device. The result is an accurate and quick determination of kidney function.
Other methods don't "scream out to you, 'Hey, my kidneys shut down yesterday,'" McDonald at Aledo said. "This is right now; it's precise."
The market for the device is growing. Medical statistics show acute kidney failure affects 7 percent of all hospitalized patients and 15 percent of ICU patients. At least half of those afflicted will die.
Chronic kidney disease is at epidemic levels, particularly because of rising diabetes and hypertension rates. It is estimated that 13 percent of Americans-or one in eight-have kidney disease, contributing to higher health care rates. Detecting kidney disease quicker could cut mortality rates and health care costs.
BioCrossroads' Indiana Seed Fund invested in FAST Diagnostics. Director David Johnson declined to divulge the exact amount, but said each of its six investments has been between $250,000 and $500,000.
"We get a huge number of applications here," he said, "and they're a great company-very, very promising."
FAST's primary markets are ICU and cardiac catheterization patients. There are roughly 6,000 units nationwide that treat 55,000 patients daily. About 1.3 million cardiac catheterization procedures are performed in the United States annually.
An assessment of the glomerular filtration rate-the rate kidneys filter waste from the blood-is needed before and after the procedure due to the toxicity potential of the dyes used.
Secondary markets include pharmaceutical companies, general hospitals, nephrologists' offices and pre- and postsurgery departments.
The diagnostic device is patented while the technology is awaiting approval. About 20 students and researchers from the School of Medicine and Rose-Hulman Institute of Technology in Terre Haute also have been involved in development.