Microfluidic Platform for Multiplexed Diagnostics

Information

  • Research Project
  • 8269155
  • ApplicationId
    8269155
  • Core Project Number
    R01AI098853
  • Full Project Number
    1R01AI098853-01
  • Serial Number
    098853
  • FOA Number
    RFA-AI-11-014
  • Sub Project Id
  • Project Start Date
    9/1/2012 - 12 years ago
  • Project End Date
    8/31/2016 - 8 years ago
  • Program Officer Name
    HALL, ROBERT H.
  • Budget Start Date
    9/1/2012 - 12 years ago
  • Budget End Date
    8/31/2013 - 11 years ago
  • Fiscal Year
    2012
  • Support Year
    01
  • Suffix
  • Award Notice Date
    8/23/2012 - 12 years ago

Microfluidic Platform for Multiplexed Diagnostics

DESCRIPTION (provided by applicant): Urgent need exists for developing next-generation clinical diagnostics devices for screening individuals exposed to and/or intoxicated with biological threat agents. These devices need to be capable of rapid, sensitive, and specific diagnosis to enable effective countermeasures including therapeutic intervention. Such systems must also be easy-to-use, automated and self-contained, and preferably have a small footprint to allow use in point-of-care and point-of-incident settings. Our goal is to develop, with our commercial partners Invetech and Bio-Rad, a manufacturable and commercializable device (SpinDx) in preparation for 510(k) submission to the FDA. The device is intended for use in primary care facilities, public health labs, and military clinics overseas for detection of NIAID priority pathogens and toxins Botulinum, Anthrax, Ricin, Shiga-like toxin, and Staphyloccocus enterotoxin B (SEB) in clinical samples. Invetech will design and develop Beta prototypes ready for field-testing at Sandia and two independent laboratories using spiked human samples as well as serum and nasal swabs from intoxicated/infected mice. A test-bed version of the device has already been demonstrated with ultra-sensitive detection of a number of analytes including biotoxins (e.g., our assay for Botulinum toxin A is ~100-fold more sensitive than the gold-standard mouse bioassay). The device uses centrifugal force-driven flow to implement bead-based sandwich immunoassays and activity assays in a plastic disk, and can rapidly (<10 min) and sensitively (~ fM) detect multiple analytes using a few ?L of clinical sample. The diagnostic device, owing to its bead-based assay format, is readily adaptable to detection of other pathogens and disease markers. The device requires no off-device sample preparation and is compatible with multiple bodily fluids including whole blood, serum, saliva, and urine. We have assembled a multidisciplinary team for development, manufacturing and testing of SpinDx which includes, in addition to Sandia, Invetech and Bio-Rad, two institutions for developing animal models for intoxication/infection - United States Department of Agriculture's Western Regional Research Center (USDA-WRRC) in Albany, CA and University of Texas Medical Branch (UTMB) at Galveston, TX; and two sites for independent, blind testing of the device at UTMB Allied Health hospital lab and USDA-WRRC. PUBLIC HEALTH RELEVANCE: The proposed device will be a multi-purpose medical diagnostic device that can be used to diagnose people potentially exposed to a biotoxin or pathogen. It can also be used to diagnose many other systemic diseases and conditions such as cancer and heart disease.

IC Name
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
  • Activity
    R01
  • Administering IC
    AI
  • Application Type
    1
  • Direct Cost Amount
    628221
  • Indirect Cost Amount
    221240
  • Total Cost
    849461
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    855
  • Ed Inst. Type
  • Funding ICs
    NIAID:849461\
  • Funding Mechanism
    Non-SBIR/STTR RPGs
  • Study Section
    ZAI1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    SANDIA CORP-SANDIA NATIONAL LABORATORIES
  • Organization Department
  • Organization DUNS
    007113228
  • Organization City
    ALBUQUERQUE
  • Organization State
    NM
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    871233453
  • Organization District
    UNITED STATES