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STAT Palm-Sized Blood Counter

Award Number: R44HL099092
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/09/2010
PERIOD OF PERFORMANCE END DATE: 04/30/2019

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STAT Palm-Sized Blood Counter - ¿ DESCRIPTION (provided by applicant): The overarching objective of this proposal is to attain data for FDA 510(k) submission of a handheld miniaturized STAT Blood Counter using 5-10 µL blood to yield a complete blood count (CBC) with 3-part differential. This dramatically decreased size and sample volume creates new opportunities in delivery of these hematology tests, ultimately leading to more streamlined, available, and on demand care. In Phase I, we showed proof-of-concept for our microfluidic approach for blood dilution, developed a miniature flow cytometry module, and demonstrated impedance measurements of blood. In Phase II, we developed a microvolume sample consumable, demonstrated blood dilution in our spiral vortexer micromixer, brought our miniature optical block's performance up to par with larger cytometers, and developed a concept model of our blood sensor. Here in this Phase IIB, we plan to fully engineer a product version of our STAT Blood Counter and validate it at Boston Children's Hospital. We are proposing that most of the product development will occur in Years 1-2 and the validation and submission in Year 3. At the conclusion of the effort, we will have submitted our technology for FDA 510(k) approval for CBC with 3-part differential. This will enable capabilities for measuring blood loss, infection, and bleeding risk in a range of different settings including the clinic, emergency rooms, ambulances, developing countries, and the field.


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: 2019 ( Subtotal = $0 )
2019	2018	DNA MEDICINE INSTITUTE, INC., THE	727 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Blood Diseases and Resources Research	000	6	9/3/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $1,000,000 )
2018	2018	DNA MEDICINE INSTITUTE, INC., THE	727 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Blood Diseases and Resources Research	000	6	5/2/2018	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2017 ( Subtotal = $1,000,000 )
2017	2017	DNA MEDICINE INSTITUTE, INC., THE	727 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Blood Diseases and Resources Research	000	5	4/27/2017	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2016 ( Subtotal = $1,000,000 )
2016	2016	DNA MEDICINE INSTITUTE	727 MASSACHUSETTS AVENUE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Cardiovascular Diseases Research	000	4	5/16/2016	COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2013 ( Subtotal = $486,288 )
2013	2013	DNA MEDICINE INSTITUTE	727 MASSACHUSETTS AVENUE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Blood Diseases and Resources Research	000	3	7/1/2013	NON-COMPETING CONTINUATION	$486,288
														Subtotal = $486,288

Issue Date FY: 2012 ( Subtotal = $486,288 )
2012	2012	DNA MEDICINE INSTITUTE	727 MASSACHUSETTS AVENUE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Blood Diseases and Resources Research	000	2	6/21/2012	COMPETING CONTINUATION	$486,288
														Subtotal = $486,288

Grand Total All Awards = $3,972,576

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STAT Palm-Sized Blood Counter

Award Number: R44HL099092

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/09/2010

PERIOD OF PERFORMANCE END DATE: 04/30/2019

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