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Whole Blood Point of Care Metabolic Measurement

Award Number: R44HD107897
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/17/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2024

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Whole Blood Point of Care Metabolic Measurement - Project Summary This SBIR Phase II project will translate Phase I technical innovations in sensor materials and a prototype device into a fully functional point of care technology for whole blood biomarker monitoring. It will culminate in a complete draft of a 510(k) clearance application to the U.S. Food & Drug Administration (FDA). Currently, no commercial FDA cleared point of care device is available for direct measurement of this biomarker in whole blood. All large clinical instruments require separation of plasma from whole blood via centrifugation prior to measurement. Further, current clinically used measurements, which rely on plasma separated from whole blood, suffer from inaccurate results from pre-analytical variability in sample handling. Phase I completed technical innovations supported by the National Science Foundation yielded 1) increased sensor specificity, by eliminating signals from interferents, 2) increased sensor sensitivity through sensing material improvements, and 3) direct point of care measurement from whole blood, instead of plasma separated ex-situ from the measurement device which eliminated pre-analytical variability in sample handling. This novel point of care whole blood measurement device will be used to improve at-home management of the ~10,000 people living with these rare metabolic disorders and as a newborn screening to improve identification of the ~1/3500 newborns with rare metabolic disorders out of the 3.9 million annual births in the United States. Ultimately, manufacturing of consumable, single use sensors and sensor readers will create new jobs in the United States. In this Direct Phase II project, Sequitur Health Corp. will partner with Arizona State University and Mayo Clinic to innovate a process for mass production of the laboratory-scale sensors developed from the Phase I project and subsequently analytically and clinically validate the mass-produced sensors and reader technology for FDA 510(k) clearance.


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 = $899,442 )
2023	2023	SEQUITUR HEALTH CORP.	12826 E CIBOLA RD	SCOTTSDALE	AZ	85259	MARICOPA	USA	Child Health and Human Development Extramural Research	001	3	9/1/2023	SUPPLEMENT FOR EXPANSION	$196,280
2023	2023	SEQUITUR HEALTH CORP.	12826 E CIBOLA RD	SCOTTSDALE	AZ	85259	MARICOPA	USA	Child Health and Human Development Extramural Research	000	3	8/31/2023	NON-COMPETING CONTINUATION	$703,162
														Subtotal = $899,442

Issue Date FY: 2022 ( Subtotal = $829,934 )
2022	2022	SEQUITUR HEALTH CORP	12826 E CIBOLA RD	SCOTTSDALE	AZ	85259	MARICOPA	USA	Child Health and Human Development Extramural Research	001	2	8/25/2022	NON-COMPETING CONTINUATION	$633,654
2022	2022	SEQUITUR HEALTH CORP	12826 E CIBOLA RD	SCOTTSDALE	AZ	85259	MARICOPA	USA	Child Health and Human Development Extramural Research	002	2	8/26/2022	SUPPLEMENT FOR EXPANSION	$196,280
2022	2021	SEQUITUR HEALTH CORP	12826 E CIBOLA RD	SCOTTSDALE	AZ	85259	MARICOPA	USA	Child Health and Human Development Extramural Research	000	1	6/28/2022	NEW	$0
														Subtotal = $829,934

Issue Date FY: 2021 ( Subtotal = $637,832 )
2021	2021	SEQUITUR HEALTH CORP	12826 E CIBOLA RD	SCOTTSDALE	AZ	85259	MARICOPA	USA	Child Health and Human Development Extramural Research	000	1	9/17/2021	NEW	$637,832
														Subtotal = $637,832

Grand Total All Awards = $2,367,208

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Whole Blood Point of Care Metabolic Measurement

Award Number: R44HD107897

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/17/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2024

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