HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--Cicero Diagnostics Inc., a women’s healthcare diagnostic company, is pleased to announce the awarding of a $1 million Phase II SBIR Fast Track grant from the National Institutes of Health (NIH). The grant, titled "SIRT1 and BCL6: Dual Biomarkers of Endometriosis and Endometrial Receptivity” follows completion of Phase I, successfully demonstrating concordance of the protein markers BCL6 and SIRT1 to endometriosis, a leading cause of unexplained infertility. According to the American Society of Reproductive Medicine, endometriosis is associated with 30-50% of all cases of unexplained infertility (over 500,000 cases a year). Cicero Diagnostic’s on-going commercialization of protein markers to assess uterine receptivity impacted by endometriosis inflammation has proven to be a significant breakthrough in helping women successfully achieve pregnancy.
Cicero Diagnostics currently offers BCL6 as part of their ReceptivaDx™ test for unexplained infertility, failed implantation and recurrent pregnancy loss. Over 300 fertility centers representing more than 1,000 reproductive endocrinologists across the US and globally are successfully using the test for assessing uterine lining dysfunction typically caused by endometriosis without the cost and invasiveness of surgical laparoscopy. Once identified and treated, outcomes data from both published studies and fertility centers using the test commercially have demonstrated significantly higher success rates in women with IVF failure histories.
Chris Jackson, CEO of Cicero Diagnostics, states, “We’re proud that ReceptivaDx has helped so many women challenged with infertility. While IVF success rates are now approaching 50-60%, we remain focused on finding answers for the 40-50% of patients where IVF and genetic testing of embryos still doesn’t result in pregnancy. This doesn’t even begin to address the financial and emotional toll experienced by these women, their partners and their families as a result of those failures. By detecting uterine lining conditions without requiring expensive invasive surgery, we have created a tremendous value proposition for women that have experienced IVF failure and want answers before repeating the IVF process. Phase II of the NIH grant will also let us focus on developing testing for the 85% of women in the US that don’t have fertility coverage or the means for seeking advanced fertility help. Expanding the offering to the OB market has been a goal of Cicero Diagnostics from day one and remains a primary goal looking forward.”
The Phase II portion of the NIH grant includes a broad range of prestigious universities with significant experience in fertility studies. Patients will be drawn from three main centers and include Wake Forest Health Sciences, University of North Carolina and Stanford University. The NIH grant will continue studies building on published data already in the public domain showing the accuracy of these markers in uncovering and treating women with unexplained infertility. The study is designed to end in late 2021.
Specifically, the new studies will:
- Establish the relative impact of SIRT1 and/or BCL6 to predict IVF outcome in different patient groups and less invasive collection types such as saliva.
- Establish the role of estrogen suppression on biomarker expression and treatment outcome in women with suspected endometriosis and positive endometrial BCL6 and/or SIRT1 expression.
- Expand the acceptability and indications for BCL6/SIRT1 biomarker testing.
Cicero Diagnostics is a medical diagnostic company located in Huntington Beach, California. ReceptivaDx™ is the company’s signature test panel in the area of unexplained infertility. Cicero Diagnostics is the exclusive licensed provider of BCL6 and SIRT1 for the detection of endometriosis. Working with IVF centers across the U.S. and in 15 other countries, Cicero Diagnostics continues to expand their offering globally and is investing in continuing research in the field.