Soleno Therapeutics, Inc. — Department of Health and Human Services SBIR Phase II: NHLBI

Description

SUMMARY More thanbabies are born annually with sickle cell diseaseSCDof which occur in developing countrieswith the largest number in NigeriaA majority of children with SCD die beforeyearsbut when early SCD screening is coupled with health care managementmortality can be reduced dramaticallyUnfortunatelybecause universal screening requires blood samples from infantsit is rarely done in resource limited settings where it is expensive and hard to implementA simpleeconomical and portable point of carePOCscreening test that is well accepted by familiesavoids the need for blood samplingand is easily integrated into the existing community health care system without diverting time and resources from other healthcare priorities is critically neededTo this endCapnia has modified the portable CoSense End Tidal Carbon MonoxideETCOMonitor to make it suitable for point of care use as a SCD screening tool in tropical climatesThe monitor non invasively measures carbon monoxide in breatha byproduct of hemolysisand clearly distinguishes between children with or without SCDBecause measurements can be made without a forced breath sampleit is suitable for use in infants and young children who cannot reliably follow sample collection commandsFurtherthe only disposable item required is an inexpensive nasal cannulaThusthis simple to use device meets all of the desirable characteristics for use as a SCD screening tool in low resource settingsIn order to fully prepare the device and develop an SCD screening regimen for commercial deployment we propose four aimsIn Aimwe will determine the optimal age at which infants should be screened using ETCO and a recommended ETCO threshold at which they should be referred for further SCDWe will also define the sensitivity and specificity of detecting SCD in Nigerian childrenIn Aimwe will enhance the usability of CoSense S to make it suitable for field use in Nigeria and develop training materials to support its commercial deployment for SCD screeningWork in Aimwill test the reliability and ease of use of CoSense S in field conditions in NigeriaOur goal is to test and validate the modified monitorCoSense Sfor SCD screening in the field in NigeriaIf successfulwe will be ready to commercialize a device that will for the first time make widespread screening for SCD feasible in low resource settings