NEW YORK--(BUSINESS WIRE)--Today, Celmatix, a next-generation women’s health company, announced that the Fertilome® genetic test has received full regulatory approval by the New York State (NYS) Department of Health (DOH) Clinical Laboratory Evaluation Program (CLEP). The Fertilome test is the first multigene panel test for reproductive conditions to be approved by NYS, which is known for having the most stringent requirements of the state agencies that regulate laboratory developed tests (LDTs). LDTs are not currently regulated by the FDA.
Announced in January 2017, the Fertilome test has already been ordered for numerous women by reproductive specialists and OB-GYNs across the U.S. through a pre-approval program administered by NYS. The test offers physicians genetic insights into how a woman’s DNA may be impacting her reproductive health in sub-clinical ways that may not be apparent through traditional fertility tests that interrogate hormone levels.
The test was developed after seven years of ground-breaking research. Celmatix scientists combined insights from over 1.1 million unique data points from more than 5,000 published clinical studies with findings from thousands of functional studies. This big data analysis resulted in the identification and statistical validation of 49 variants in 32 genes that have been associated with reproductive conditions that can impact a woman’s fertility including endometriosis, recurrent pregnancy loss, polycystic ovary syndrome, and early menopause.
“We chose to launch in New York--the only state that requires that a test demonstrate both clinical validity and clinical utility to be eligible for approval--because from the beginning, we were committed to creating a test that is both clinically valid and useful,” said Dr. Piraye Yurttas Beim, PhD, Founder and CEO of Celmatix. “We are very sensitive to the emotional and financial burdens on women considering egg freezing or undergoing fertility treatments. Personalized medicine, which leverages genetic insights about an individual to guide treatment and counseling decisions, is nascent in the field of reproductive health. Many genomics companies launch in New York State last or not at all because of the high bar set by the NYS DOH. We felt it was important, both to deliver peace of mind to our customers and also to set the standards high for the field, to hold ourselves to the highest standards from day one.”
“The stringent criteria for approval in New York State serves as a guidepost for clinical laboratories across the country, and having achieved this approval is a strong validation of the science and methodology behind our groundbreaking test,” said Dr. Lesley E. Northrop, PhD, FACMG, Clinical Laboratory Director, Celmatix Clinical Laboratories. “We are proud of this landmark moment for Celmatix and for the field of reproductive health. The era of personalized reproductive medicine has begun.”
For more information on Celmatix and the Fertilome test, please visit http://www.celmatix.com.
About Celmatix Inc.
Celmatix is a next-generation women’s health company transforming reproductive health care through genomics and big data. Founded in 2009 and based in New York City, Celmatix is disrupting how women approach their lifelong fertility journey by empowering them and their physicians with more personalized information. The company’s research-driven products include the Fertilome® test, the world’s first multigene panel test that reveals what a woman’s DNA says about her reproductive health, and Polaris®, a real-time predictive analytics platform in use at leading fertility clinics across the U.S., which helps physicians optimize patient outcomes and improve the patient experience.