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Microfluidic Platform for Multiplexed Diagnostics

Award Number: R01AI098853
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2012
PERIOD OF PERFORMANCE END DATE: 08/31/2017

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2021 ( Subtotal = -$88 )
2021	2015	NATIONAL TECHNOLOGY & ENGINEERING SOLUTIONS OF SANDIA, LLC	1515 EUBANK SE	ALBUQUERQUE	NM	87123	BERNALILLO	USA	Allergy and Infectious Diseases Research	002	4	10/3/2020	NON-COMPETING CONTINUATION	$88
2021	2015	NATIONAL TECHNOLOGY & ENGINEERING SOLUTIONS OF SANDIA, LLC	1515 EUBANK SE	ALBUQUERQUE	NM	87123	BERNALILLO	USA	Allergy and Infectious Diseases Research	000	4	10/1/2020	NON-COMPETING CONTINUATION	-$88
2021	2015	NATIONAL TECHNOLOGY & ENGINEERING SOLUTIONS OF SANDIA, LLC	1515 EUBANK SE	ALBUQUERQUE	NM	87123	BERNALILLO	USA	Allergy and Infectious Diseases Research	001	4	10/3/2020	NON-COMPETING CONTINUATION	-$88
														Subtotal = -$88

Issue Date FY: 2018 ( Subtotal = -$1,901 )
2018	2015	NATIONAL TECHNOLOGY & ENGINEERING SOLUTIONS OF SANDIA, LLC	1515 EUBANK SE	ALBUQUERQUE	NM	87123	BERNALILLO	USA	Allergy and Infectious Diseases Research	000	4	2/1/2018	NON-COMPETING CONTINUATION	-$1,901
														Subtotal = -$1,901

Issue Date FY: 2015 ( Subtotal = $671,492 )
2015	2015	SANDIA NATIONAL LABORATORIES	P.O. BOX 5800	ALBUQUERQUE	NM	87185	BERNALILLO	USA	Allergy and Infectious Diseases Research	000	4	8/13/2015	NON-COMPETING CONTINUATION	$671,492
														Subtotal = $671,492

Issue Date FY: 2014 ( Subtotal = $1,091,058 )
2014	2014	SANDIA NATIONAL LABORATORIES	P.O. BOX 5800	ALBUQUERQUE	NM	87185	BERNALILLO	USA	Allergy and Infectious Diseases Research	000	3	7/31/2014	NON-COMPETING CONTINUATION	$1,091,058
														Subtotal = $1,091,058

Issue Date FY: 2013 ( Subtotal = $906,932 )
2013	2013	SANDIA NATIONAL LABORATORIES	P.O. BOX 5800	ALBUQUERQUE	NM	87185	BERNALILLO	USA	Allergy and Infectious Diseases Research	000	2	8/9/2013	NON-COMPETING CONTINUATION	$906,932
														Subtotal = $906,932

Issue Date FY: 2012 ( Subtotal = $849,461 )
2012	2012	SANDIA NATIONAL LABORATORIES	P.O. BOX 5800	ALBUQUERQUE	NM	87185	BERNALILLO	USA	Allergy and Infectious Diseases Research	000	1	8/23/2012	NEW	$849,461
														Subtotal = $849,461

Grand Total All Awards = $3,516,954

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Microfluidic Platform for Multiplexed Diagnostics

Award Number: R01AI098853

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2012

PERIOD OF PERFORMANCE END DATE: 08/31/2017

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