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Point-of-birth newborn screening for MCAD/VLCAD and galactosemia to eliminate deadly delays for time critical conditions

Award Number: R44HD088211
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: 08/15/2017
PERIOD OF PERFORMANCE END DATE: 07/31/2020

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Point-of-birth newborn screening for MCAD/VLCAD and galactosemia to eliminate deadly delays for time critical conditions - We aim to revolutionize the traditional newborn screening paradigm by developing a point-of-care digital microfluidic platform for biochemical screening of fatty acid oxidation disorders (FAOs) and galactosemia. These disorders are inborn errors of metabolism that have profound neurological and hypoglycemic effects if not detected early. Although these disorders are included in traditional newborn screening with a multi-day turnaround, infants still die due to the “deadly delays” inherent to the system of transporting dried blood spots to a central laboratory. Confirmation of a diagnosis of common FAOs by enzymatic or molecular analysis can take months, leaving families in a stressful position of uncertainty. Point-of-care testing by enzyme activity is critical to address these issues. As of yet there is not a single point-of-care newborn screening technology available for biochemical screening or diagnostic confirmation. Baebies’ digital microfluidic platform is a recognized innovative, affordable, automated microdroplet-based liquid handling system that can be configured to address this challenge. The digital microfluidic technology enables miniaturization of assays and significantly reduces reagent and sample volumes while providing timely data to guide clinical intervention. Baebies is guided by a vision that every newborn deserves a healthy start. Baebies’ current product is for a laboratory setting and has been in use for over 2 years in the state of Missouri for the first ever newborn screening pilot study of multiple lysosomal storage disorders in the United States. The proposed point-of-birth (POB) newborn screening platform utilizes the same underlying digital microfluidic technology and aims for a time-to-result of 15 minutes so that prompt treatment through a controlled feeding schedule can be initiated. The project objective is to demonstrate technical feasibility of using digital microfluidics to detect medium-chain acyl-CoA dehydrogenase (MCAD) deficiency, very-long-chain acyl-CoA dehydrogenase (VLCAD) deficiency and galactosemia in whole blood samples for improved newborn screening at the point-of-birth. The Phase I specific aims include biochemistry development of the assays on whole blood samples, integration and analytical validation of the multiplexed panel, and preliminary method comparison using blood samples from newborns at the University of Pittsburgh. In Phase II, we will complete hardware development of the point-ofbirth platform, complete development of a self-contained cartridge, and perform a pilot study for method comparison. The point-of-birth platform will have the ability to expand to other time-critical conditions in the future.


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 = -$6,750 )
2021	2018	BAEBIES, INC.	615 DAVIS DR STE 800	MORRISVILLE	NC	27560	WAKE	USA	Child Health and Human Development Extramural Research	000	3	2/7/2021	NON-COMPETING CONTINUATION	-$6,750
														Subtotal = -$6,750

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	001	3	8/12/2019	NON-COMPETING CONTINUATION	$0
2019	2016	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	1	7/15/2019	NEW	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $696,600 )
2018	2018	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	3	8/29/2018	NON-COMPETING CONTINUATION	$696,600
														Subtotal = $696,600

Issue Date FY: 2017 ( Subtotal = $917,787 )
2017	2017	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	001	2	8/15/2017	EXTENSION WITH OR WITHOUT FUNDS	$917,787
2017	2016	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	1	8/11/2017	NEW	$0
														Subtotal = $917,787

Issue Date FY: 2016 ( Subtotal = $254,130 )
2016	2016	BAEBIES INC	PO BOX 14403	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	1	9/15/2016	NEW	$254,130
														Subtotal = $254,130

Grand Total All Awards = $1,861,767

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Point-of-birth newborn screening for MCAD/VLCAD and galactosemia to eliminate deadly delays for time critical conditions

Award Number: R44HD088211

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: 08/15/2017

PERIOD OF PERFORMANCE END DATE: 07/31/2020

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