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Novel technologies for detection of podocytes from preeclamptic patients

Award Number: R44HD090786
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: 09/22/2016
PERIOD OF PERFORMANCE END DATE: 08/31/2021

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Novel technologies for detection of podocytes from preeclamptic patients - Preeclampsia is a complication of pregnancy characterized by elevated blood pressure, proteinuria, and endothelial dysfunction involving multiple organ systems. Worldwide, preeclampsia is the largest cause of fetal and maternal morbidity and mortality, and accounts for nearly 16% of maternal deaths in the United States alone each year. Currently, there is no approved diagnostic test to predict which patients will develop preeclampsia. Patients with preeclampsia require hospitalization and continuous monitoring of the mother and fetus, thus, there is an urgent and unmet need for a diagnostic test that can identify those patients at risk for preeclampsia. Preeclampsia is diagnosed when a patient’s blood pressure measures =140/90 mm Hg twice at least 4 hours apart and either proteinuria or one of the following conditions is present: thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema or visual disturbances. Significant efforts are underway to detect preeclampsia prior to disease onset. Recently, it was demonstrated that glomerular podocytes are shed into the urine of preeclamptic patients and can be visualized using podocyte-specific antibodies. Moreover, shed podocytes can be detected in the second trimester, prior to preeclampsia diagnosis, with high sensitivity and specificity. Methods to detect podocytes currently rely on overnight culture and sedimentation of cells onto collagen-coated slides or Cytospin, which is prone to high false-positive rates due to contaminating red blood cells (RBCs) or casts. Inconsistencies in the method of podocyte detection and lengthy, overnight incubations susceptible to contamination weaken the utility of podocytes as a diagnostic marker of preeclampsia. We have identified proprietary peptides that bind with high affinity to podocytes but not to blood or urothelial cells, and we have developed a cell-specific coating for glass slides that provides a simple, reproducible method for preparing optimal capture slides from samples contaminated with blood and urothelial cells. A reduction in non-diagnostic results will improve the quality of podocyte capture and lead to significant cost savings by minimizing turnaround time and the need for expensive equipment. 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: 2022 ( Subtotal = $0 )
2022	2019	AFFINERGY, LLC	104 TW ALEXANDER DRIVE, BLDG. 20	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	4	2/28/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $653,488 )
2019	2019	AFFINERGY, LLC	601 KEYSTONE PARK DR STE 100	MORRISVILLE	NC	27560	WAKE	USA	Child Health and Human Development Extramural Research	000	4	8/3/2019	NON-COMPETING CONTINUATION	$653,488
														Subtotal = $653,488

Issue Date FY: 2018 ( Subtotal = $638,707 )
2018	2018	AFFINERGY, LLC	601 KEYSTONE PARK DR STE 100	MORRISVILLE	NC	27560	WAKE	USA	Child Health and Human Development Extramural Research	000	3	8/7/2018	NON-COMPETING CONTINUATION	$638,707
														Subtotal = $638,707

Issue Date FY: 2017 ( Subtotal = $707,804 )
2017	2017	AFFINERGY, LLC	601 KEYSTONE PARK DR STE 100	MORRISVILLE	NC	27560	WAKE	USA	Child Health and Human Development Extramural Research	000	2	9/11/2017	COMPETING CONTINUATION	$707,804
														Subtotal = $707,804

Grand Total All Awards = $1,999,999

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Novel technologies for detection of podocytes from preeclamptic patients

Award Number: R44HD090786

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: 09/22/2016

PERIOD OF PERFORMANCE END DATE: 08/31/2021

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