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Improving Anticoagulation Monitoring in Pediatric Patients: Use of a Microfluidic Platform to Test Low Volume Blood Samples Obtained by Heel-Stick Collection

Award Number: R44HL140662
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2018
PERIOD OF PERFORMANCE END DATE: 03/31/2025

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Improving Anticoagulation Monitoring in Pediatric Patients: Use of a Microfluidic Platform to Test Low Volume Blood Samples Obtained by Heel-Stick Collection - ABSTRACT Improving Anticoagulation Monitoring in Pediatric Patients: Use of a Microfluidic Platform to Test Low Volume Blood Samples Obtained by Heel-Stick Collection (HL140662 Phase IIB SBIR) Anticoagulation therapy is indicated for children who suffer from congenital heart defects, thrombosis, or who are at risk of developing thrombosis. Over the past decade, there has been a dramatic increase in the use of anticoagulation therapies in pediatric patients, with up to 15% of hospitalized children receiving heparin or heparinoids. The use of these therapies necessitates frequent laboratory testing (every 4 hours) of multiple analytes -- anti-thrombin function (ATIII), Factor Xa activity (Xa), and activated partial thromboplastin time (aPTT) -- to avoid underdosing (thrombotic events) or overdosing (bleeding). Existing diagnostics for heparin therapy are problematic in newborns and children as they are generally standardized for adult samples and require as much as 2 mL of whole blood per analyte or a cumulative blood volume of up to 12 mL per day for the full panel. There is a critical unmet need to develop a low-volume, minimally invasive, and rapid turn-around diagnostic test panel for monitoring heparin therapy in children that features multiple analyte testing on a single platform. Work completed through Phase I and II of this project (R44HL140662) has established feasibility to perform a panel of three critical assays (ATIII, Xa, and aPTT) for laboratory quality monitoring of anticoagulants (heparin, heparinoids) on our near patient digital microfluidic platform (FINDER). This platform was recently CE marked for glucose-6-phosphate dehydrogenase (G6PD) testing and is pending 510(k) clearance from the FDA. The proposed Phase IIB project will support full analytical validation per CLSI guidelines and a rigorous clinical validation necessary to obtain FDA clearance for our heparin assay panel. We are preparing to engage in a pre- submission with the FDA regarding our validation protocols and design of the validation studies to meet 510(k) requirements based on single test predicate devices for each analyte. We are working closely with our clinical partners at Boston Children’s Hospital to optimize the heparin testing platform workflow for seamless integration into a hospital laboratory setting upon commercialization. Funding through this Phase IIB mechanism will complete the developmental path for our FINDER heparin monitoring platform, from concept to market through anticipated FDA clearance. There is currently no single point-of-care testing platform available that supports rapid testing of ATIII, Xa, and aPTT. The small volume format inherent to our digital microfluidic technology enables all three assays to be performed with less than 50 L of whole blood or plasma, collected via heel-stick or venipuncture, and is perfectly suited for use in pediatric settings where frequent blood draws significantly increase the risk of iatrogenic anemia. By combining three technically complex assays into a single, automated platform, we can improve both technical performance of heparin monitoring assays (reduced sample-to-answer time, three analyte test results from a single blood sample) and improve clinical outcomes through reduced blood volume needed for recurrent testing of heparin and other anticoagulants.


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: 2025 ( Subtotal = -$16,894 )
2025	2023	BAEBIES, INC.	25 ALEXANDRIA WAY	DURHAM	NC	27703	DURHAM	USA	Blood Diseases and Resources Research	000	8	8/5/2025	NON-COMPETING CONTINUATION	-$16,894
														Subtotal = -$16,894

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	BAEBIES, INC.	25 ALEXANDRIA WAY	DURHAM	NC	27703	DURHAM	USA	Blood Diseases and Resources Research	000	8	10/17/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $863,466 )
2023	2023	BAEBIES INC	25 ALEXANDRIA WAY	DURHAM	NC	27703	DURHAM	USA	Blood Diseases and Resources Research	000	8	8/30/2023	NON-COMPETING CONTINUATION	$863,466
														Subtotal = $863,466

Issue Date FY: 2022 ( Subtotal = $879,482 )
2022	2022	BAEBIES, INC.	615 DAVIS DR STE 800	MORRISVILLE	NC	27560	WAKE	USA	Blood Diseases and Resources Research	000	7	3/25/2022	NON-COMPETING CONTINUATION	$878,833
2022	2018	BAEBIES, INC.	615 DAVIS DR STE 800	MORRISVILLE	NC	27560	WAKE	USA	Blood Diseases and Resources Research	001	1	9/26/2022	NEW	$649
														Subtotal = $879,482

Issue Date FY: 2021 ( Subtotal = $1,165,799 )
2021	2021	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Blood Diseases and Resources Research	001	5	6/2/2021	NON-COMPETING CONTINUATION	$253,772
2021	2021	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Blood Diseases and Resources Research	000	6	4/30/2021	COMPETING CONTINUATION	$912,027
2021	2019	BAEBIES, INC.	615 DAVIS DR STE 800	MORRISVILLE	NC	27560	WAKE	USA	Blood Diseases and Resources Research	002	3	7/30/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,165,799

Issue Date FY: 2020 ( Subtotal = $214,063 )
2020	2020	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Blood Diseases and Resources Research	001	4	8/31/2020	COMPETING CONTINUATION	$214,063
2020	2019	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Blood Diseases and Resources Research	000	3	8/27/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $214,063

Issue Date FY: 2019 ( Subtotal = $692,626 )
2019	2019	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Blood Diseases and Resources Research	002	3	7/23/2019	NON-COMPETING CONTINUATION	$692,626
2019	2018	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Blood Diseases and Resources Research	000	1	7/12/2019	NEW	-$649
2019	2018	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Blood Diseases and Resources Research	001	2	7/12/2019	EXTENSION WITH OR WITHOUT FUNDS	$649
														Subtotal = $692,626

Issue Date FY: 2018 ( Subtotal = $1,032,209 )
2018	2018	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Blood Diseases and Resources Research	000	1	1/17/2018	NEW	$224,903
2018	2018	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Blood Diseases and Resources Research	001	2	8/16/2018	EXTENSION WITH OR WITHOUT FUNDS	$807,306
														Subtotal = $1,032,209

Grand Total All Awards = $4,830,751

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Improving Anticoagulation Monitoring in Pediatric Patients: Use of a Microfluidic Platform to Test Low Volume Blood Samples Obtained by Heel-Stick Collection

Award Number: R44HL140662

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/01/2018

PERIOD OF PERFORMANCE END DATE: 03/31/2025

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