A saliva-based HIV test developed by a University of Florida veterinarian has entered commercial production for over-the-counter distribution in selected international markets.
OraScreen HIV Rapid Test was developed by Roger Clemmons, a veterinary neurologist and associate professor of small animal clinical sciences in UF's College of Veterinary Medicine. Beacon Diagnostics, Inc. of California has an exclusive licensing agreement with UF to manufacture and distribute the product.
OraScreen detects antibodies to the HIV virus, rather than the virus itself.
Beacon began marketing the test internationally last fall. Although the product will be sold in both over-the-counter and professional versions in international markets, Beacon expects to target professional health-care markets in the United States initially, company representatives said. Beacon expects to seek U.S. Food and Drug Administration approval within two years.
"This is the first time a saliva-based screening test for HIV -- which is simple enough to allow in-home use -- will be available in some of the countries we have targeted for our product launch," said Dr. Bert Del Villano, Beacon's executive vice president. "The most significant of these are Mexico, South Africa, Brazil, the Caribbean Islands and Greece."
Beacon announced in November that it had signed a $23.4 million deal with a subsidiary of Buenos Aires-based Roemmers for exclusive distribution of OraScreen in Latin America and certain European countries.
Laboratory blood tests are available in all areas of the world, and a
few territories permit in-home blood tests to screen for HIV, Del Villano said. However, UF's dipstick-style saliva test is as effective, easier to perform and less expensive than those tests, he added.
While saliva collection devices which are mailed to a laboratory for analysis have been approved, OraScreen offers "a huge difference," Del Villano said.
"OraScreen, which gives results in 15 minutes, does away with the problems encountered when a third-party laboratory is involved, most significantly the potential for incorrectly reporting the results and the delay in getting test results back to the individual," Del Villano said.
Clemmons and Beacon have also collaborated to develop a saliva test for hepatitis B and are currently working on several new saliva tests, as well as new blood-based technology for cancer screening.
"We are pleased that Dr. Clemmons' technology is passing a critical milestone in its development," said Arnold Heggestad, director of the Division of Entrepreneurial Programs in UF's Office of Research, Technology and Graduate Education. "The university has been a believer in this technology for several years and has supported Dr. Clemmons' research. We hope Beacon's success will make this a product widely available for the public good and will provide a strong financial return to UF to be used to invest in new projects."
Beacon is planning a public stock offering this fall, said chairman David Fowler.
"This will give the company a significant infusion of capital to expand its marketing of the HIV test and to provide for the development of future tests," Fowler said. "We also expect it to give our investors, of which the University of Florida is one, a strong return on their investment and to encourage the support of future university technologies."
In the same way that pilots practice normal and emergency flight procedures in a simulator, future doctors, anesthesiologists, nurses, paramedics and other medical personnel can prepare to treat real patients on the Human Patient Simulator's life-like mannequin. The simulator is also valuable for continuing medical education.
UF has licensed the simulator technology to Loral Data Systems of Sarasota, which has sold 14 of the $200,000 devices to medical schools around the world.
"The Human Patient Simulator is an ideal learning tool for anesthesiologists and other health-care providers," said Dr. Michael Good, assistant professor of anesthesiology in the UF College of Medicine. "Computers control the patient so it automatically responds to injected medications, changes in mechanical ventilation and other therapies. It's almost as if the mannequin comes to life."
Studies at UF indicate that students acquire and retain skills better using the hands-on simulator than they do through lectures or other passive tools, like videotapes.
Researchers from UF's colleges of medicine and engineering teamed up to develop the prototype simulator, then the university licensed the technology to Loral, which has devoted its considerable industrial resources to streamline manufacturing of the device and make it rugged enough to withstand daily use.
Among the institutions that have installed the simulators are Mount Sinai Medical Center in New York, the University of North Carolina Medical School, Hamamatsu University in Japan, and Santa Fe Community College in Gainesville.
"The response of our residents and faculty to having the simulator located near the main operating room has been one of extreme enthusiasm," said Dr. Richard Kayne, director of residency training at Mount Sinai. "Even faculty who express doubts about its merits soon find themselves teaching at the bedside of the simulated patient as if it were real."
Paul Stephan, director of clinical education for the Respiratory Therapy Program at Santa Fe Community College, said that the patient simulator "helps assure that each student receives the same clinical experiences and opportunities."
Through nearly a decade of development and refinement, the project has been supported by the Florida High Technology and Industry Council, the state Department of Education, the Anesthesia Patient Safety Foundation and the Florida Technology Research Investment Fund of Enterprise Florida. Loral also supports continuing research on the simulator.
For more information about UF technologies available for licensing, contact the Office of Technology Licensing, (352) 392-8929.