CERES NANOSCIENCES — Department of Health and Human Services SBIR Phase I: NIDA

Description

PROJECT SUMMARY Prescription drug related adverse deaths rank as the fourth leading cause of death in the United StatesOpioid pain relievers constitute the most commonly abused class of drugsinvolved in overof all drug overdose deaths inMore people die from overdoses of prescription opioids than from all other drugs combinedincluding illegal drugsFentanyl is the most widely misused prescription opioidIt is often prescribed to treat severe pain but istimes more potent than heroin and carries a high risk of overdoseIn addition to being included as part of the routine drug screeningfentanyl is on the screening panel of the National Safety Councilfor workplace screeningand is being increasingly adopted for other federal guidelinese gthe Department of Transportation into ensure compliance with responsible prescribing practices and patient adherence to opioid therapyThe tests currently used to detect fentanylhoweverare problematicThe initialpoint of caretests are often quick and simplelike a dipstick testbut are widely recognized for their lack of specificity and sensitivityPoint of care tests are not great at distinguishing between fentanyl and its derivative compounds and have high false positive andnegative ratessometimes as high asFor this reasonthe positive results from these initial tests have to undergo a second round ofconfirmatorytesting at larger clinical laboratories via either gas or liquid chromatography mass spectrometryThis added step is not efficientit means greater timesometimes weeks for resultsexpenseand back logAs reported by the Drug Enforcement Administration s National Forensic Laboratory Information SystemNFLIShundreds of thousands of samples are processed each yearand this number is expected to riseBettermore sensitiveand efficient drug testing capabilities are needed to address the growing national opioid epidemicIn line with this clear need and the objectives of the HEAL initiativeCeres NanoscienceIncproposes a Phase I SBIR to demonstrate the feasibility of its smart nanoparticle technologyNanotrapas a sample concentrator to enable the fastercheaperand more discerning detection of fentanyl and its derivatives from large volumes of urineSupported by promising proof of principle datathe specific aims for this initiative are toAimdemonstrate the feasibility of Nanotrap particles to pre concentrate and improve the detection of fentanyl and its derivatives from large volume urine samplesand Aimidentify a Nanotrap workflow suitable for sample processing in multiple contextsi emedium volume reference lab and high volume confirmatory testing lab workflowsThese studies will inform a future Phase II effort aimed at expanding the capabilities of the Nanotrap fentanyl assay and evaluating its placement in real world drug testing laboratoriesUltimatelyif successfulthe formulation of Nanotrap particles into a platform that could be used by clinicalcommercialand forensic laboratories for pre testing sample enrichment of multiple fentanyl derivativesanalogsor synthetic variants could translate into more comprehensiveefficient testing practicesreduce costs for drug testingand ultimately help to address the current technical bottlenecks that are only hindering efforts to combat this national epidemic PROJECT NARRATIVE Fentanylthe most widely misused prescription opioidis often prescribed to treat severe pain but istimes more potent than heroin and carries a high risk of overdoseAccordinglythe Centers for Disease Control and Prevention reports that fentanyl was detected inof all opioid related overdose deathsOur ability to detect the presence of fentanyl and its multiple derivatives from biological fluidslike urineis complicated by the low sensitivity and specificity of current point of care testswhile higher performance confirmatory tests are expensive and take timeWork in this Phase I SBIR will evaluate the feasibility of formulating Ceres NanoscienceIncs Nanotrap technology into a platform that could be used by clinicalcommercialand forensic laboratories for pre testing sample enrichment of multiple fentanyl derivativesanalogsor synthetic variantsThese efforts could translate into more comprehensiveefficient testing practicesreduce costs for drug testingand ultimately help to address the current technical bottlenecks that are only hindering efforts to combat this national epidemic