BCL6 Biomarker Predicts IVF Success and Failure in Pivotal Study

CiceroDx, the only company to offer BCL6 for unexplained infertility,
continues to build awareness for the ReceptivaDx™ test as a
cost-effective option for improving the success of IVF.

HUNTINGTON BEACH, Calif.–(BUSINESS WIRE)–#asrm–In the latest issue of Fertility and Sterility, a cohort
study predicted IVF outcomes using an endometrial biopsy and a
biomarker for BCL6 that is highly associated with endometriosis, a
leading cause of unexplained infertility (UI). The IRB controlled study
statistically concluded that patients with UI are likely to be BCL6
positive and, if left untreated, in a very low prognostic group for
success.

The significance of this study supports an on-going trend of IVF centers
to use ReceptivaDx™
for testing patients either ahead of the first IVF cycle or after the
first failure. The ability to identify and treat these patients earlier
in the process reduces costs to the families, reduces the number of
transfers required for success and increases the CPR (clinical pregnancy
rate) and live births of an IVF center, a major indicator used to assess
performance of fertility centers who rely on stronger success rates to
attract future patients.

The study was performed over a period of 8 years through the Fertility
Center of the Carolinas, a university centered fertility clinic. All
women entered the study with a minimum of one year of failed IVF and
were tested for BCL6. Seventy five percent of the cohort tested positive
and 25% negative. Negative BCL6 results translated to a CPR rate of 75%,
consistent with the highest success rates of all IVF patients published
by the Society for Reproductive Technology (SART). However, a positive
BCL6 result translated to an 18% CPR success rate and an 11% live birth
rate putting them in a significantly poorer prognostic group.

Treatment options typically include laparoscopy to remove the
endometriosis or hormone therapy to reduce inflammation caused by
endometriosis. Both treatments are intended to provide a stable
receptive surface for the egg and have a very high success outcome based
on centers currently using the test and then treating.

According to Dr.
Bruce Lessey, a practicing Reproductive Endocrinologist in
Greenville, SC and a co-author of this new clinical data, the suspicion
that endometriosis played a role in IVF failure has long been assumed,
but rarely followed up with. “Common sense tells us that endometriosis
is a major cause of subfertility, but women undergoing IVF are rarely
diagnosed with this disease before treatment. This test provides an
opportunity for couples to better understand the basis of their
infertility and will provide more options and higher success rates.”

Lessey further states, “One of the toughest conversations you can have
with your patient is why their IVF transfer failed.” According to the
statistics provided each year by IVF centers, over 100,000 of those
“difficult conversations” are taking place each year.

Chris
Jackson, CEO of CiceroDx, stated, “Our immediate goal is to provide
all women considering IVF access to this highly predictive test. Women
and families are spending 10’s of thousands of dollars with the hopes of
starting a family. Knowing in advance their BCL6 status will ensure a
greater likelihood of success and may reduce the number of cycles
needed.”

“There is no other test like this,” according to Dr. Aimee Eyvazzadeh, a
Harvard educated Reproductive Endocrinologist located in the San
Francisco bay area. “The ReceptivaDx™ test has given me the ability to
diagnose endometriosis in patients with a simple biopsy. Being able to
do this is life changing. Through this test, I’m able to give patients a
diagnosis, explanation and most importantly an individualized protocol
and path to successful pregnancy.”

The ReceptivaDx™ test for unexplained infertility costs $690 with
results available in 3 to 5 days. The test is currently offered in over
100 IVF centers across the U.S., Canada, Europe and South America.

For more information, please visit www.ReceptivaDx.com.

About CiceroDx

CiceroDx
is a medical diagnostic company located in Huntington Beach, Calif.
ReceptivaDx™ is the company’s first testing panel in the area of
unexplained infertility. CiceroDx intends to expand their offering
globally and is investing in continued research in the field. For more
information, visit http://www.receptivadx.com/about-cicerodx.

Contacts

CiceroDx, Inc.
Dan Angress, COO
dan@cicerodx.com