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)--Feb 19, 2019--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.
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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.
View source version on businesswire.com:https://www.businesswire.com/news/home/20190219005108/en/
CONTACT: CiceroDx, Inc.
Dan Angress, 310-227-6607
KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA
INDUSTRY KEYWORD: WOMEN HEALTH BIOTECHNOLOGY CLINICAL TRIALS GENETICS BABY/MATERNITY CONSUMER GENERAL HEALTH
SOURCE: CiceroDx, Inc.
Copyright Business Wire 2019.
PUB: 02/19/2019 03:00 AM/DISC: 02/19/2019 03:01 AM