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Novel technologies to remove obscuring blood from fine needle aspiration biopsies

Award Number: R44GM106489
ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2014
PERIOD OF PERFORMANCE END DATE: 05/31/2020

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Novel technologies to remove obscuring blood from fine needle aspiration biopsies - SUMMARY/ABSTRACT Fine-needle aspiration (FNA) cytology is the standard technique for evaluating thyroid nodules. Hemorrhaging is common during the procedure, however, leading to an aspirate that is significantly diluted by blood. Subsequent slide preparations are often suboptimal, resulting in nondiagnostic outcomes that necessitate additional testing or diagnostic surgery. In fact, quality is so unpredictable that a pathologist must often be present in the operating room to certify that the slides are adequate, thus adding substantial cost and complexity to the procedure. Ancillary testing such as immunocytochemistry and fluorescence in-situ hybridization can also be used for evaluating the aspirate, but such tests are not usually carried out using smears due to a paucity of follicular cells and an abundance of red blood cells. As a result, additional slides must be prepared using expensive and time-consuming techniques. Thus, there is a significant need for increasing the capture and isolation of thyroid cells on FNA slide preparations. Affinergy is developing a novel technology for improving the quality of thyroid FNA slide preparations. We have identified proprietary peptides that binds with high affinity to thyroid cells but not to red or white blood cells, and we have developed a cell-specific coating for glass slides that provides a simple, reproducible method for preparing optimal FNA slides from samples contaminated with blood. A reduction in non-diagnostic results will lead to improved quality of care and fewer unnecessary tests and diagnostic surgeries. At the conclusion of this Phase II project, we will have sufficient data in hand to rapidly bring our peptide-conjugated slides to market.


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 = -$10,102 )
2023	2018	AFFINERGY, LLC	104 TW ALEXANDER DRIVE, BLDG. 20	DURHAM	NC	27709	DURHAM	USA	Biomedical Research and Research Training	000	4	2/22/2023	SUPPLEMENT FOR EXPANSION	-$10,102
														Subtotal = -$10,102

Issue Date FY: 2021 ( Subtotal = -$21,513 )
2021	2018	AFFINERGY, LLC	601 KEYSTONE PARK DR STE 100	MORRISVILLE	NC	27560	WAKE	USA	Biomedical Research and Research Training	000	4	12/9/2020	SUPPLEMENT FOR EXPANSION	-$21,513
														Subtotal = -$21,513

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	AFFINERGY, LLC	601 KEYSTONE PARK DR STE 100	MORRISVILLE	NC	27560	WAKE	USA	Biomedical Research and Research Training	000	4	11/8/2018	SUPPLEMENT FOR EXPANSION	$0
2019	2018	AFFINERGY, LLC	601 KEYSTONE PARK DR STE 100	MORRISVILLE	NC	27560	WAKE	USA	Biomedical Research and Research Training	002	4	4/9/2019	SUPPLEMENT FOR EXPANSION	$0
2019	2017	AFFINERGY, LLC	601 KEYSTONE PARK DR STE 100	MORRISVILLE	NC	27560	WAKE	USA	Biomedical Research and Research Training	001	4	4/9/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $203,640 )
2018	2018	AFFINERGY, LLC	601 KEYSTONE PARK DR STE 100	MORRISVILLE	NC	27560	WAKE	USA	Biomedical Research and Research Training	000	4	9/10/2018	SUPPLEMENT FOR EXPANSION	$203,640
														Subtotal = $203,640

Issue Date FY: 2017 ( Subtotal = $696,963 )
2017	2017	AFFINERGY, LLC	617 DAVIS DR STE 100	DURHAM	NC	27713	DURHAM	USA	Biomedical Research and Research Training	000	4	5/11/2017	NON-COMPETING CONTINUATION	$696,963
														Subtotal = $696,963

Issue Date FY: 2016 ( Subtotal = $702,576 )
2016	2016	AFFINERGY LLC	POST OFFICE BOX 14650	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Biomedical Research and Research Training	000	3	5/13/2016	NON-COMPETING CONTINUATION	$702,576
														Subtotal = $702,576

Issue Date FY: 2015 ( Subtotal = $698,109 )
2015	2015	AFFINERGY LLC	POST OFFICE BOX 14650	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Biomedical Research and Research Training	000	2	5/14/2015	COMPETING CONTINUATION	$698,109
														Subtotal = $698,109

Grand Total All Awards = $2,269,673

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Novel technologies to remove obscuring blood from fine needle aspiration biopsies

Award Number: R44GM106489

ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/01/2014

PERIOD OF PERFORMANCE END DATE: 05/31/2020

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