The University of Maryland (UM) in Baltimore and Sequella, Inc. have signed an exclusive license agreement for a wristwatch-sized device that will monitor a patient's compliance with a prescribed therapeutic regimen.
The parties signed an enhanced agreement on an existing deal, which will allow Sequella, Inc. to more effectively bring the invention to market.
The cost of all patients not complying properly to their drug regimens adds about $290 billion to the U.S. health care system each year, says Leo Einck, PhD, chief scientific officer with the Rockville, Md.-based pharmaceutical company.
The Event Marker System (EMS), as the company calls the invention, is designed to detect levels of a fluorescent "tag" built into pills. "Monitoring drug adherence is a hot topic and now the problem can be solved" with the EMS, says Einck. "It is easy to use, noninvasive, and a lifestyle device capable of reminding patients of their daily dosing time, and also tracking." The technology was invented by Joseph Lakowicz, PhD, a professor in the Department of Biochemistry and Molecular Biology at the UM School of Medicine.
Twenty to 33 percent of patients on new prescriptions for chronic disease do not adhere to their medications beyond the first 30 days, says Fadia Shaya, PhD, MPH, associate professor with the UM School of Pharmacy. Once patients get the first refill, their nonadherence rates can range from 20 to 60 percent depending on the medication, its side effects, and the age, gender, and race of the patient, she says.
The UM patent states that the technology can be either "for determining whether individuals are complying with prescribed therapeutic regimens, or for providing a mechanism for identifying drug-resistant strains of infectious agents." Particularly in the field of infectious disease, doctors assume that if the patient has fully complied with a course of antibiotics and the infection remains, that the pathogen is drug resistant. This device will tell doctors that the patient has not complied with the full course and the infection may not be drug resistant after all.
Lakowitz says that pills can be tagged with a harmless chemical that glows green (or other colors) when UV light is shined on it. When the patient takes the pill the chemical gets into the bloodstream. The wristwatch-sized device periodically shines the UV light and measures the presence of the chemical.
The inventors believe the device could transmit the information to a caregiver, such as a physician, nurse, or family member through a wi-fi network or a cellular phone network. It could also detect multiple colors of chemicals for multiple drugs. "We are delighted to continue this relationship with Sequella to bring this exciting technology to market," says James L. Hughes, MBA, the vice president for research and development for the Baltimore campus of the University of Maryland.
Einck is co-founder of Sequella with CEO Carol Nacy, PhD.
Lakowitz is director of the University of Maryland Center for Fluorescence Spectroscopy, supported by the National Center for Research Resources in the National Institutes of Health, with additional support from the UM School of Medicine, Center for Biomedical Engineering and Technology, and the UM Graduate School at Baltimore.