Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

Developing a non-invasive, definitive diagnostic for endometriosis using biomarkers in menstrual effluence

Award Number: R44HD103159
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: 02/15/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2024

Group Awards By:

View Award Description

Developing a non-invasive, definitive diagnostic for endometriosis using biomarkers in menstrual effluence - Summary Endometriosis is a complex disease that on average, involves a ten-year gap between symptom onset and diagnosis. Moreover, due to the current surgical nature of endometriosis diagnosis (laparoscopy), research studies involving confirmed cases are both difficult to obtain and costly to recruit for. Laparoscopic surgery (recovery times 2-6 weeks) followed by histological confirmation is considered the gold standard for diagnosis. However, even with surgical intervention, 50% of patients have recurrence, underlining the fact that endometriosis shows periodic states of activation, regardless of surgical or therapeutic intervention. Consequently, a non-invasive, reliable biomarker test for endometriosis is a significant unmet medical need. A non-invasive diagnostic for endometriosis would motivate earlier detection of disease and could fundamentally change a patient’s prognosis by preventing disease progression. Menstrual fluid is a rich source of reproductive tissue that can be utilized for disease diagnosis. Next Gen Jane are developing a menstrual effluent competent collection tool, the Smart Tampon System (STS) which addresses issues of non-invasive sample accessibility and ease of sample transport to a laboratory. Toward development of a reliable biomarker for endometriosis, our preliminary data with the STS device indicates we can detect multiple RNA species in menstrual effluent, some of which have been previously discovered in other related studies. We believe that the STS provides unparalleled ease of access to menstrual effluent and markedly improves sample handling efficiencies. These factors alongside the demonstrated utility of the STS as a sample for RNASeq (amongst other studies) differentiates this proposal from other non-invasive approaches to detection of endometriosis. Our goal is to develop a non-invasive ”yes/no” diagnostic test for endometriosis by examining the genomic signatures of endometrial tissue shed into a tampon during menstruation. In order to further identify and evaluate the performance of genomic markers in menstrual fluid, we will enroll 72 patients with a negative or positive surgical confirmation of endometriosis in order to: Firstly, confirm previously identified biomarkers from pilot data that evaluates diagnosis of disease. Secondly, we will use statistical classification of RNASeq data to examine ~300 pre- and post- laparoscopy matched patient samples to confirm sensitivity and specificity of miRNA and mRNA biomarkers in concert with patient survey data.


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: 2024 ( Subtotal = $0 )
2024	2023	NEXTGENJANE INC	400 29TH ST	OAKLAND	CA	94609	ALAMEDA	USA	Child Health and Human Development Extramural Research	000	3	8/23/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $401,530 )
2023	2023	NEXTGEN JANE, INC.	400 29TH ST STE 105	OAKLAND	CA	94609	ALAMEDA	USA	Child Health and Human Development Extramural Research	000	3	1/25/2023	NON-COMPETING CONTINUATION	$401,530
														Subtotal = $401,530

Issue Date FY: 2022 ( Subtotal = $1,108,476 )
2022	2022	NEXTGEN JANE, INC.	400 29TH ST STE 105	OAKLAND	CA	94609	ALAMEDA	USA	Child Health and Human Development Extramural Research	001	2	2/8/2022	EXTENSION WITH OR WITHOUT FUNDS	$1,108,476
2022	2020	NEXTGEN JANE, INC.	400 29TH ST STE 105	OAKLAND	CA	94609	ALAMEDA	USA	Child Health and Human Development Extramural Research	000	1	2/8/2022	NEW	$0
2022	2020	NEXTGEN JANE, INC.	400 29TH ST STE 105	OAKLAND	CA	94609	ALAMEDA	USA	Child Health and Human Development Extramural Research	002	1	6/1/2022	NEW	$0
														Subtotal = $1,108,476

Issue Date FY: 2020 ( Subtotal = $267,669 )
2020	2020	NEXTGEN JANE, INC.	400 29TH ST STE 105	OAKLAND	CA	94609	ALAMEDA	USA	Child Health and Human Development Extramural Research	000	1	8/21/2020	NEW	$227,426
2020	2020	NEXTGEN JANE, INC.	400 29TH ST STE 105	OAKLAND	CA	94609	ALAMEDA	USA	Child Health and Human Development Extramural Research	001	1	9/25/2020	NEW	$40,243
														Subtotal = $267,669

Grand Total All Awards = $1,777,675

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Developing a non-invasive, definitive diagnostic for endometriosis using biomarkers in menstrual effluence

Award Number: R44HD103159

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: 02/15/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2024

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer