# SIRT1 and BCL6: Dual Biomarkers of Endometriosis and Endometrial Receptivity

> **NIH NIH R44** · CICERODX, INC. · 2021 · $463,322

## Abstract

PROJECT SUMMARY/ABSTRACT
Endometriosis is a common and poorly understood disease affecting millions of women around the world. The 
impact on fertility and pelvic pain is estimated to cost $22 billion dollars, but this does not include the costs to 
treat IBS, interstitial cystitis and the cost of failed Assisted Reproductive Technology (ART) cycles. It is 
estimated that 40% of failed ART cycles are due to undiagnosed endometriosis, and most women undertaking 
ART have never been tested. This proposal is based on established technology that detects all stages of 
endometriosis. Based on published results, women who over-express the oncogene BCL6 have a 47% 
reduction in live birth rate compared to women with normal BCL6. This proposal will develop this technology, 
validate these findings and pursue a less invasive test format. Aims including those in Phase I, which will 
validate and examine a second co-expressed biomarker, Sirtuin 1 (SIRT1) present in endometriosis cases at 
all phases of the menstrual cycle in women with documented endometriosis. This first phase will also study 
expression of SIRT1 and BCL6 in alternative tissue sources including blood, saliva, urine, and cervical mucous 
using ELISA technology. Aims in Phase II will examine expression of BCL6 and/or SIRT1 as predictors of 
pregnancy outcomes in at a major IVF center. In women who test positive for SIRT1/BCL6 with suspected 
endometriosis, a second multi-center study will examine whether suppression of endometriosis with a novel, 
newly approved GnRH agonist (Elagolix) followed by embryo transfer will improve outcomes. Finally, the team
will develop, validate, and commercialize a reference laboratory test for endometriosis and endometrial 
receptivity using less invasive approaches for measuring SIRT or BCL6 based on Phase I results. The final 
validation of a reference laboratory test will involve prospective testing before laparoscopy for pelvic pain or 
infertility (cases and infertile controls) and for women with fertility undergoing tubal ligation for permanent 
sterilization (fertile controls). With this approach the sensitivity, specificity, and negative and positive predictive 
value can be defined. The goal for this project is to establish a validated new, less invasive, test for 
endometriosis by 2021 that will allow all physicians treating women to shorten the time to diagnosis for 
endometriosis in a variety of clinical settings including pelvic pain, infertility, irritable bowel syndrome and other 
pelvic complaints.

## Key facts

- **NIH application ID:** 10104525
- **Project number:** 5R44HD097750-03
- **Recipient organization:** CICERODX, INC.
- **Principal Investigator:** Dan Angress
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $463,322
- **Award type:** 5
- **Project period:** 2020-02-01 → 2024-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10104525

## Citation

> US National Institutes of Health, RePORTER application 10104525, SIRT1 and BCL6: Dual Biomarkers of Endometriosis and Endometrial Receptivity (5R44HD097750-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10104525. Licensed CC0.

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