The National Institutes of Health (NIH) awarded a Phase II SBIR Fast Track grant totaling $1 million to Cicero Diagnostics, which is investigating the usefulness of the proteins SIRT1 and BCL6 as biomarkers of infertility associated with endometriosis.
The NIH grant, “SIRT1 and BCL6: Dual Biomarkers of Endometriosis and Endometrial Receptivity,” follows the completion of the Phase I portion of the award. That phase supported studies showing that both protein markers were concordant with endometriosis, one of the leading causes of unexplained female infertility.
Cicero has developed protein markers that can evaluate how uterine receptivity, which plays a crucial role in the establishment of a healthy pregnancy, is affected by inflammation associated with endometriosis. The company said its continuing commercialization of these protein markers represents a significant breakthrough when it comes to helping women conceive.
Currently, Cicero offers testing for BCL6 as part of its ReceptivaDx test, which comprises a panel of markers used for patients with unexplained infertility, unsuccessful implantation, and recurring pregnancy loss.
“We’re proud that ReceptivaDx has helped so many women challenged with infertility,” Cicero CEO Chris Jackson said in a press release. “While IVF [in vitro fertilization] 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.”
More than 300 fertility centers worldwide are using ReceptivaDx to evaluate abnormalities in the tissue lining the inside of the uterus, which are typically caused by endometriosis. ReceptivaDx alleviates the need for women to undergo laparoscopy, a surgical diagnostic procedure that is both costly and invasive.
“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,” Jackson said.
The research will build on previously published data showing the accuracy of the protein markers in identifying and treating women with unexplained infertility. The study is expected to conclude by late 2021.
The new studies supported by the Phase II grant have three aims. First, researchers will attempt to establish if SIRT1 and BCL6 can predict IVF outcomes in different patient groups using less invasive methods, such as collecting saliva.
Studies will also investigate if and how low levels of estrogen affect these biomarkers and treatment outcomes in women with suspected endometriosis who test positive for BCL6 and/or SIRT1 in the endometrium (the tissue lining the inside of the uterus).
Researchers will also seek to expand the acceptability and indications for which BCL6 and SIRT1 may be used as biomarkers.
“Phase II of the NIH grant will also let us focus on developing testing for the 85% of women in the U.S. that don’t have fertility coverage or the means for seeking advanced fertility help,” Jackson said. “Expanding the offering to the OB market has been a goal of Cicero Diagnostics from day one, and remains a primary goal looking forward.”