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Rapid and Simple Paper Strip Test for the Multiplexed Detection of Gastrointestinal Pathogens at the Point-of-Need

Award Number: R44TR001912
ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary GoDx Phase 2 Rapid and Simple Paper Strip Test for the Multiplexed Detection of Gastrointestinal Pathogens at the Point-of-Need In this Phase 2 SBIR project, we will be developing the prototype multiplexed paper strip device for the detection of gastrointestinal pathogens at the point-of-need in < 30 minutes. We have demonstrated the feasibility of a novel and simple stool sample preparation using hollow microsphere “molecular buoys”, and the multiplexed detection of DNA using isothermal amplification in Phase 1. In Phase 2, we will develop and evaluate our multiplexed prototype device. We will evaluate the prototype device using 800 samples from an NIH-IRB approved protocol through our CRADA collaboration with Dr. Wendy A. Henderson at the NIH. We expect a sensitivity (>90%) and specificity (>90%) to the Biofire PCR GI Panel data on the same samples. The goal of the Phase 2 project is to develop an optimized prototype that will be evaluated in the IDE-exempt NIH clinical study. We will also develop for commercialization a Research Use Only kit for the point-of-need purification of nucleic acids using our microsphere sample preparation technology.


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: 2023 ( Subtotal = -$27,676 )
2023	2021	GODX INC.	510 CHARMANY DR STE 265	MADISON	WI	53719	DANE	USA	National Center for Advancing Translational Sciences	000	3	2/14/2023	SUPPLEMENT FOR EXPANSION	-$27,676
														Subtotal = -$27,676

Issue Date FY: 2021 ( Subtotal = $597,814 )
2021	2021	GODX INC.	510 CHARMANY DR STE 265	MADISON	WI	53719	DANE	USA	National Center for Advancing Translational Sciences	000	3	10/31/2020	SUPPLEMENT FOR EXPANSION	$597,814
2021	2021	GODX INC.	510 CHARMANY DR STE 265	MADISON	WI	53719	DANE	USA	National Center for Advancing Translational Sciences	002	3	6/10/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2019	GODX INC.	510 CHARMANY DR STE 265	MADISON	WI	53719	DANE	USA	National Center for Advancing Translational Sciences	001	3	6/10/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $597,814

Issue Date FY: 2020 ( Subtotal = $432,593 )
2020	2020	GODX INC.	510 CHARMANY DR STE 265	MADISON	WI	53719	DANE	USA	National Center for Advancing Translational Sciences	002	3	4/22/2020	SUPPLEMENT FOR EXPANSION	$192,999
2020	2020	GODX INC.	510 CHARMANY DR STE 257	MADISON	WI	53719	DANE	USA	National Center for Advancing Translational Sciences	001	3	12/15/2019	SUPPLEMENT FOR EXPANSION	$239,594
2020	2019	GODX INC.	510 CHARMANY DR STE 257	MADISON	WI	53719	DANE	USA	National Center for Advancing Translational Sciences	000	3	11/13/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $432,593

Issue Date FY: 2019 ( Subtotal = $1,204,574 )
2019	2019	GODX INC.	510 CHARMANY DR STE 257	MADISON	WI	53719	DANE	USA	National Center for Advancing Translational Sciences	000	2	1/28/2019	SUPPLEMENT FOR EXPANSION	$88,424
2019	2019	GODX INC.	510 CHARMANY DR STE 257	MADISON	WI	53719	DANE	USA	National Center for Advancing Translational Sciences	001	3	7/10/2019	NON-COMPETING CONTINUATION	$1,116,150
														Subtotal = $1,204,574

Issue Date FY: 2018 ( Subtotal = $966,680 )
2018	2018	GODX INC.	510 CHARMANY DR STE 257	MADISON	WI	53719	DANE	USA	National Center for Advancing Translational Sciences	000	2	7/17/2018	COMPETING CONTINUATION	$966,680
														Subtotal = $966,680

Grand Total All Awards = $3,173,985

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Rapid and Simple Paper Strip Test for the Multiplexed Detection of Gastrointestinal Pathogens at the Point-of-Need

Award Number: R44TR001912

ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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