An Ultrasensitive, High-Throughput, and Low-Cost Autoimmunity Panel for the Early Diagnosis and Improved Treatment of Type 1 Diabetes

Information

  • Research Project
  • 9559575
  • ApplicationId
    9559575
  • Core Project Number
    R44DK111005
  • Full Project Number
    2R44DK111005-02
  • Serial Number
    111005
  • FOA Number
    PA-17-302
  • Sub Project Id
  • Project Start Date
    8/1/2016 - 8 years ago
  • Project End Date
    3/31/2020 - 4 years ago
  • Program Officer Name
    ARREAZA-RUBIN, GUILLERMO
  • Budget Start Date
    4/20/2018 - 6 years ago
  • Budget End Date
    3/31/2019 - 5 years ago
  • Fiscal Year
    2018
  • Support Year
    02
  • Suffix
  • Award Notice Date
    4/20/2018 - 6 years ago
Organizations

An Ultrasensitive, High-Throughput, and Low-Cost Autoimmunity Panel for the Early Diagnosis and Improved Treatment of Type 1 Diabetes

Type 1 diabetes (T1D) is a devastating autoimmune disease that destroys islet-cell insulin production. Millions of Americans, especially children, are affected and must rely on lifelong insulin administration and struggle with life-threatening co-morbidities. Most new cases of T1D are diagnosed in emergency settings with presentation in potentially deadly diabetic ketoacidosis (DKA). Current pre-clinical diagnostic tests that can permit preventive action for T1D are slow and not readily available outside of tertiary care centers. In 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 type 1 diabetes. Such a test could supplant the current expensive, slow radioactive method. By reducing costs while retaining sensitivity and specificity with a robust very low-sample volume assay, Enable Biosciences' product will permit increased testing to reveal incipient T1D in the general population at the optimal time for intervention. During the Phase I funding period, Enable prototyped a 3-member T1D autoantibody panel using their core Antibody Detection by Agglutination-PCR (ADAP) technology and demonstrated substantial equivalence with the gold-standard assay while removing reliance on radioactive reagents. In this Phase 2 proposal, Enable presents a comprehensive plan to enhance this panel via automation using a dedicated robotic liquid handling system, greatly increasing assay throughput and reliability while further reducing costs. We will also adapt our assay chemistry to be able to use Taqman probes. This will result in further throughput acceleration and cost reductions. Building upon promising preliminary results from Phase 1 work, we will incorporate the fourth and final T1D autoantibody (ZnT8) to create the world's first ever ?4-in-1? screening panel, creating a product that provides the highest level of risk assessment for T1D screening and diagnosis. These 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 Center, Stanford School of Medicine, the T1D Exchange and Tufts Children's Hospital. This 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 easy, low-skill use and deployment across research and clinical laboratories and screening sites worldwide.

IC Name
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
  • Activity
    R44
  • Administering IC
    DK
  • Application Type
    2
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    749838
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    847
  • Ed Inst. Type
  • Funding ICs
    NIDDK:749838\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    ENABLE BIOSCIENCES, INC.
  • Organization Department
  • Organization DUNS
    079962225
  • Organization City
    MENLO PARK
  • Organization State
    CA
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    940256908
  • Organization District
    UNITED STATES