SiDx, Inc. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

SUMMARY Millions of blood samples are tested annually to establish blood type compatibility between blood donors and transfusion recipientsHowevercurrent testing methods are encumbered by the need for large blood samplestransportation to centralized laboratoriestime to centrifuge and perform testingspecialized reagentsand technical training needsplacing a costly burden on the medical systemIn particularreduced blood sampling volumes are desirable to avoid exacerbating anemia in patients who may require transfusionparticularly pediatric and critically ill patientsAdditionallycurrent test times create the need to maintain universal units to provide emergency transfusions when the blood type of the patient is not yet knownplacing a strain on the blood supplyThusthere is a need for smallerfasterbetterand cheaper blood group testingOur proposed solution will perform blood group testing on a multiplexedlow costand scalable silicon nanophotonic biochipThis technology has been demonstrated in proof of concept studies to detect ABand RhDDblood groups and anti A and anti B antibodies in small volume blood samplesSiDxInchas licensed the core intellectual propertyengaged an experienced FDA regulatory consultantand secured seed funding to commercialize this technologyThis application is seeking SBIR support for SiDx to advance this blood group testing technology towards readiness for FDA studieswith the future goal of FDA regulatory approval and commercialization of the product as a medical diagnosticIn this SBIR Fast Track Phase I II applicationwe propose specific aims for each of the two PhasesIn Phase I we propose one aimto develop proof of concept assays to functionalize silicon photonic biosensors for the detection of blood groups CEand KThese blood groups are critical minor blood group antigens that can provoke severepotentially life threatening immune reactions and bring value in expanding the multiplexed blood group testing capabilities of the future productIn Phase IIwe proposeaimsAim IIto study surface functionalization conditions and optimize surface capture of streptavidin via covalentsilaneand non covalentphysisorptionmeans on silicon photonic surfaces for blood group antigen and antibody assay validationand Aim IIto multiplex ABODCEand K blood group assaysand controlson optimized functional surfaces using an inkjet arrayer and test assay performanceThis aim will also assess samples that can challenge conventional testing methods in the clinical laboratorysuch as weak D and mixed field reactions This silicon photonic blood typing chip holds the promise to modernize blood group testing with simplefastfully automated multiplexed blood group testing in small volume blood samplesWe predict thatif successfulthis product holds the potential to transform both blood group testing and transfusion medicine through small sample volume requirementsfully automated testingand rapid time to resultsThis should reduce iatrogenic blood lossdelays in transfusionminimize the use of universal unitsand improve access in hospitals that currently have limited resources to support blood group testing capabilities NARRATIVE Blood type testing is done prior to blood transfusion to enable the blood bank to choose a safe blood product that is compatible with the blood type of the patientCurrent blood typing methods require large volume blood samples and must be sent to a specialized laboratory where testing is performed by trained laboratory staffresulting in delays in transfusionemergencies where patients have to be transfused without knowing their blood typeand the risk of worsening the patient s anemia by taking so much blood for testingWe propose to develop for commercialization a silicon photonic blood group testing chip that can test blood type using a small sample quicklyeasilyand near the patientenabling faster transfusion decisionsreducing strain on the blood bank s supply of universal unitsand improved patient care