Thursday, February 19, 2026 2/19/2026

Clinical utility of novel biomarkers for prediction of early pregnancy failure

Award Number: R01HD110448
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: 02/01/2023
PERIOD OF PERFORMANCE END DATE: 01/31/2028

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Clinical utility of novel biomarkers for prediction of early pregnancy failure - Abstract: The diagnosis and management for women who are at risk for ectopic pregnancy (EP) and spontaneous abortion (SAB), has not changed substantially in decades. While ultrasound can diagnose a significant portion of women at presentation, because of its limited accuracy in abnormal and early gestation, a large number of women need serial tests and procedures to determine the final location and viability of an early pregnancy. Misdiagnosis and iatrogenic complications during this time are still too common. This conundrum results in great stress and uncertainty for women undergoing clinical care and their health care teams. To date, we have demonstrated (and validated) that multiplexed biomarkers from divergent biological pathways can be used to minimize both false positive and false negative discrimination (rather than balancing the two errors with lower accuracy). In parallel, we have discovered and screened more than 54 novel biomarkers to obtain 11 candidates that can predict early pregnancy outcome. Using machine learning we have demonstrated that as few as 3 of these markers can predict the location of an early gestation (IUP vs EP or SAB) with 95% accuracy. Additionally, an overlapping group of 3 markers can predict the viability of a gestation (IUP vs SAB or EP) with 94% accuracy. When both tests are used in combination the accuracy is 96.9%. We now plan to externally validate these companion diagnostic(s) in a separate population-based prospective study and to determine the optimal conditions of use. We will optimize performance in women presenting with a pregnancy of unknown location as well as assess predictive values for all women presenting at risk for early pregnancy loss using an independent population-based prospective study (SA1). We will determine if accuracy can be improved with the combination of presenting signs, symptoms, and ultrasound findings (SA2). Moreover, we will validate our biomarker tests in two distinct populations of interest: women with high and low risk for EP: a) asymptomatic women prior to presentation for care (EAGeR Trial) and b) women diagnosed with a persistent pregnancy of unknown location (ACTorNOT Trial) (SA3). Developing novel biomarkers that distinguish normal physiology from the presence of gynecologic disorders is an NICHD research priority area. Our productive and established team is proposing rigorous cross disciplinary, state of the art, and novel research with great scientific impact that has the potential to produce a paradigm shift in clinical care models for the diagnosis and management of women in early pregnancy. Our detailed plan for biomarker development is iterative and nimble and, importantly, includes validation. Our development plan is informed by methodology from successful biomarker development, is designed to minimize known pitfalls, and is developed with FDA guidance.


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: 2026 ( Subtotal = $597,672 )
2026	2026	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Child Health and Human Development Extramural Research	000	4	1/27/2026	NON-COMPETING CONTINUATION	$597,672
														Subtotal = $597,672

Issue Date FY: 2025 ( Subtotal = $669,511 )
2025	2025	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Child Health and Human Development Extramural Research	001	3	5/9/2025	NON-COMPETING CONTINUATION	$66,951
2025	2025	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Child Health and Human Development Extramural Research	000	3	1/16/2025	NON-COMPETING CONTINUATION	$602,560
														Subtotal = $669,511

Issue Date FY: 2024 ( Subtotal = $671,048 )
2024	2024	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Child Health and Human Development Extramural Research	001	2	5/7/2024	NON-COMPETING CONTINUATION	$61,004
2024	2024	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Child Health and Human Development Extramural Research	000	2	1/29/2024	NON-COMPETING CONTINUATION	$610,044
														Subtotal = $671,048

Issue Date FY: 2023 ( Subtotal = $718,383 )
2023	2023	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Child Health and Human Development Extramural Research	000	1	1/30/2023	NEW	$718,383
														Subtotal = $718,383

Grand Total All Awards = $2,656,614

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Clinical utility of novel biomarkers for prediction of early pregnancy failure

Award Number: R01HD110448

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: 02/01/2023

PERIOD OF PERFORMANCE END DATE: 01/31/2028

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