New Clinical Study Further Validates Use of ReceptivaDx™ (BCL6) Testing for Women with Unexplained Infertility by Demonstrating Successful Treatment Outcomes, Improved Live Birth Rates and Reduced Miscarriage Rates

HUNTINGTON BEACH, Calif.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/asrm?src=hash” target=”_blank”gt;#asrmlt;/agt;–CiceroDx, Inc., a women’s healthcare diagnostic company, is pleased to
announce the publication of a pivotal study demonstrating the
effectiveness of both medical or surgical treatment in unexplained
infertility patients with abnormal endometrial BCL6 expression. The
paper, Medical or surgical treatment before embryo transfer improves
outcomes in women with abnormal endometrial BCL6 expression by Likes CE
et al,
published in the Journal of Assisted Reproduction and
Genetics, continues to support the growing empirical evidence showing
the relationship of BCL6 expression with endometrial inflammation and
suspected endometriosis.

Previous studies demonstrated that women with abnormal BCL6 expression
(Positive ReceptivaDx™ result) had less than a 11% chance of success in
the IVF setting if left untreated. This new study shows that if treated,
surgically or medically, the success rate leading to a live birth goes
up 4 fold to greater than 50% on the next transfer cycle. Another key
finding in the study demonstrated significantly lower miscarriage rates
in patients receiving treatment compared to a control group that was
left untreated. The study gives thousands of women with unexplained
infertility new hope and a new pathway to success, potentially saving
thousands of dollars on IVF cycles by identifying patients in advance
with low likelihood of IVF success if left untreated.

The prospective cohort study, performed over a seven-year period from
2011-2018, included women between 27-42 and with at least one year of
unexplained infertility along with a host of other qualifying
parameters, both pre and post testing to ensure a uniform patient mix.
All subjects were tested for BCL6 (ReceptivaDx™) via an endometrial
biopsy. Treatment results were divided into surgical (laparoscopy) or
medical suppression with GnRH agonist (depot leuprolide acetate;
Lupron®, Abbvie, Inc.) for two months. Both groups were compared to an
untreated control cohort.

Results are illuminating. The dramatic improvement in clinical pregnancy
rates and live birth rates as well as the reduction in miscarriage rates
among the treated segment bring into question the role of undiagnosed
endometriosis on IVF outcomes following fresh or frozen embryo
transfers. No study to date has performed this type of investigation
where endometriosis is detected using endometrial biomarker expression.

“This study supports what the 240 fertility centers currently using the
test are already experiencing by identifying women with abnormal BCL6
and treating them before proceeding to another IVF cycle. We are
delighted with the findings and will continue to pour resources into
additional studies that support our mission of finding answers for women
with unexplained infertility,” said Chris Jackson, CEO of CiceroDx, Inc.

CiceroDx is a medical diagnostic company located in Huntington Beach,
California. ReceptivaDx is the company’s first test panel in the area of
unexplained infertility. The ReceptivaDx test costs $690 with results
available in 3-5 days. The company also offers an additional marker to
detect endometritis, another condition known to impact fertility.
Working with IVF centers across the country and in Europe, CiceroDx,
Inc. intends to expand their offering globally and is investing in
continuing research in the field.

For more information or access to paper abstract, go to ReceptivaDx.com.

Contacts

CiceroDx, Inc.
Dan Angress, 310-227-6607

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