Research Project
8838511
DESCRIPTION (provided by applicant): Electrochemical Home Monitoring System for Lithium Blood Level Over the past 50 years, pharmaceutical lithium has been one of the most widely-used and prescribed drugs for the effective treatment of bipolar disorder and other manic disorders. Despite the long history of use and efficacy, controlling patient blood levels in the narrow therapeutic range (~0.6 - 1.2mm/L Li+) still remains a challenge. A dose below this range may be ineffective, and a dose above this range may cause serious side effects of lithium toxicity. Currently, a fast, accurate, and inexpensive point-of-care method for detecting lithium blood levels does not exist. Available methods for detecting lithium in blood all require expensive and bulky analytical instrumentation, such as atomic absorption spectrophotometry or blood chemistry analyzer systems. The time delays and high cost of sending patients or blood samples to off-site clinical analytical laboratories remains a significant impediment to effective lithium treatment, particularly with respect to the frequent monitoring required during the onset of treatment and for desired compliance monitoring. Suboptimal treatment of bipolar disorder can lead to traumatic and costly hospitalizations. Therefore, Giner proposes to offer the first commercially-available, handheld lithium monitor for rapid and inexpensive blood lithium analysis for point-of-care use, at home or in a clinician's office. During Phase II, Giner successfully designed and fabricated a tabletop prototype lithium monitor utilizing a new, patentable electroanalytical technique and low-cost disposable sensing chips for accurately detecting lithium in patient serum samples and in blood samples. During Phase IIB, Giner will further develop the lithium monitor into a commercial product that incorporates plug-and-play disposable cartridges into a handheld device performing the electroanalytical technique, and displaying the lithium blood concentration to the user. The Giner Point-of-Care Lithium Monitor will also offer an automated calibration scheme, an automated device maintenance check, and remote communication of patient data to the clinician's office. Phase IIB concludes with a comparative study with clinical blood samples from a finger prick to provide equivalency data for a 510(k) filing for the first product model.
