SBIR Phase I: Point-of-Care Electrochemical Platform for the Rapid Detection of Drug Toxicity

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is that poisoning by prescription drugs affects over one million people annually and is the leading cause of injury-related death in the United States. Other than opioids, prescribed benzodiazepines, antipsychotics, and antidepressants are the most common causes of accidental poisoning and attempted suicide. Drug testing plays a central role in the detection and management of poisoned patients, and the ability to rapidly identify the cause and institute prompt targeted treatment has the potential to reduce morbidity and save lives. Currently, screening of blood and other biological fluids for toxic drug levels requires specimen processing, taking hours or days to obtain results from commercial laboratories. Immediate, accurate, low-cost testing for urgent care in the ambulance or emergency room will improve outcomes for the rapid diagnosis and care of patients after accidental poisoning and attempted suicide. The biosensor device and drug testing methods described in this project can be performed for low cost at the first point of contact and are scalable for rapid commercial and clinical adoption into a global drug screening market valued at $1.1 billion. This Small Business Innovation Research (SBIR) Phase I project will test a new solid-state biosensor device reporting real-time and accurate quantification of toxic drug levels in the blood using inexpensive, disposable test strips similar to a diabetes glucometer or from saliva like a sublingual electronic thermometer. Current drug toxicity assays use specialized laboratory methods that require blood sample processing and can take hours to days to obtain results. Biosensors are an interface between biology and electronics that convert specific chemical information into measurable electronic signals (e.g. a glucometer). The three specific outcomes of this project will be; 1) a handheld medical device providing accurate and real-time measurement of blood levels of all classes of antipsychotic, neuroleptic, and anticonvulsant drugs in clinical use, and other common drugs of abuse, from a drop of blood or saliva, 2) validation of the accuracy of the biosensor for target drugs relative to current laboratory analysis methods (e.g., mass spectroscopy), and 3) demonstration that the biosensor can distinguish between classes of medications, drugs of abuse, and potential clinical interferents in blood using specific analytical methods and modifiable biosensor coatings. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.