SBIR-STTR Award

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.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is that poisoning by drugs of abuse affects almost 3 million people annually and is the leading cause of injury-related death in the United States. There were 100,306 opioid overdose deaths in the US in 2021, the majority of which were due to fentanyl poisoning. Screening patients for toxic drug levels currently requires specimen processing in hospital laboratories, taking hours to obtain results. Immediate, accurate detection of fentanyl poisoning at the point of contact, in the ambulance or emergency room, will create a new paradigm for the rapid diagnosis and improved care of poisoned patients and save lives. The SBIR Phase II project outcome will be an FDA-ready, hand-held sensor device capable of accurately measuring fentanyl and other drug levels from a drop of blood or saliva within minutes. The platform device uses disposable sensor strips and is low cost and scalable, permitting broad commercial adoption. Future potential applications for this point of care testing technology include its use by physicians for office-based screening for therapeutic drug monitoring to confirm compliance and optimize medication use and efficacy. This Small Business Innovation Research (SBIR) Phase II project will test an innovative, prototype biosensor device that provides the user with real time, accurate detection and quantification of toxic drug levels in the blood using inexpensive, disposable test strips similar to a diabetes glucometer. The research to be performed in the Phase II project will utilize electroanalytical methods to optimize the performance of the sensor to improve its selectivity and lowest limit of detection for fentanyl and other drugs commonly associated with poisoning. Additional methods, sensor coatings, and testing conditions will be used to detect total-drug levels in the blood and demonstrate that the biosensor can distinguish between classes of medications and potential clinical interferents as well as show equivalent results to current clinical laboratory methods. The biosensor will detect drugs of overdose and other medications below therapeutic levels, without specimen processing. Pilot large animal studies will seek to validate the correlation of drug levels in the blood with saliva to establish a proof of concept for rapid sublingual testing for drug toxicity.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.