Feb. 19, 2020 11:00 UTC

HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)-- Cicero Diagnostics Inc., a womens 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 Diagnostics 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, Were 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 doesnt result in pregnancy. This doesnt 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 dont 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:

Cicero Diagnostics is a medical diagnostic company located in Huntington Beach, California. ReceptivaDx is the companys 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.

For more information, go to http://www.CiceroDx.com or http://www.ReceptivaDx.com.

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Cicero Diagnostics Awarded $1 Million NIH Grant to Further Research on Markers for Unexplained Infertility, Failed Implantation and Recurrent...

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