Enable Biosciences Inc. — Department of Health and Human Services SBIR Phase II: 200

Description

TypediabetesT Dis a devastating autoimmune disease that destroys islet cell insulin productionMillions of Americansespecially childrenare affected and must rely on lifelong insulin administration and struggle with life threatening co morbiditiesMost new cases of T D are diagnosed in emergency settings with presentation in potentially deadly diabetic ketoacidosisDKACurrent pre clinical diagnostic tests that can permit preventive action for T D are slow and not readily available outside of tertiary care centersIn this proposal Enable Biosciences will further develop and validate a novel low cost and high throughput immunoassay to rapidly and sensitively screen for the four cardinal autoantibody markers that predict risk for typediabetesSuch a test could supplant the current expensiveslow radioactive methodBy reducing costs while retaining sensitivity and specificity with a robust very low sample volume assayEnable Biosciencesandaposproduct will permit increased testing to reveal incipient T D in the general population at the optimal time for interventionDuring the Phase I funding periodEnable prototyped amember T D autoantibody panel using their core Antibody Detection by Agglutination PCRADAPtechnology and demonstrated substantial equivalence with the gold standard assay while removing reliance on radioactive reagentsIn this PhaseproposalEnable presents a comprehensive plan to enhance this panel via automation using a dedicated robotic liquid handling systemgreatly increasing assay throughput and reliability while further reducing costsWe will also adapt our assay chemistry to be able to use Taqman probesThis will result in further throughput acceleration and cost reductionsBuilding upon promising preliminary results from Phaseworkwe will incorporate the fourth and final T D autoantibodyZnTto create the worldandapos s first everinscreening panelcreating a product that provides the highest level of risk assessment for T D screening and diagnosisThese optimized and automated panels will then be rigorously validated with thousands of clinical samples provided by our wide network of enthusiastic academic and institutional partners that include the Joslin Diabetes CenterStanford School of Medicinethe T D Exchange and Tufts Childrenandapos s HospitalThis data will be used to plan and direct commercialization efforts that will include a phased approach from delivering a CLIA certified laboratory service to FDA approved reagent kits with companion integrated sample to answer hardware devices for easylow skill use and deployment across research and clinical laboratories and screening sites worldwide Current tests for typediabetes are too expensive and slow to be deployed early and often enough to engage adequate preventive resources or spur emerging therapeutic strategies that can slow or arrest the disease and help avoid death due to frequently fatal diabetic ketoacidosisDKAEnable Biosciences is developing the worldandapos s first fully automatedmultiplex and highthroughput autoantibody screening panel that will facilitate more frequent testing and potentially general population screening to help predict onset of T DM before it happens to help prevent death due to unanticipated DKA in childrenSuch a test could improve the lives of millions worldwide by providing both risk assessment and timely diagnosis enabling improved treatment optionsespecially for young children who are most vulnerable and disproportionately affected by T D