Celmatix, on a mission to help women and their doctors get better outcomes on fertility issues, has created a new test that can help women conceive easily.
The women’s health and fertility startup announced a new test called Fertilome which screens for alterations in 32 genes that are associated with reproductive health. Signs and symptoms of endometriosis, polycystic ovarian syndrome and primary ovarian insufficiency could indicate fertility issues at a time.
“We want women to be proactive, to know the risks. Genetics is not destiny – it is a guide,” Celmatix CEO and founder Dr. Piraye Yurttas Beim said.
Most women are testing for mutations in the BRCA1 and BRCA2 genes, which could also indicate increased risk of breast cancer. Beim says that fertilome tests can be similarly used to help guide a woman on her path to pregnancy.
Currently, doctors only test a single gene when a woman faces difficulty in conceiving but fertilome tests for multiple genes at a time.
However, the FDA does not regulate most genetic tests, but the situation is expected to change few years to come. Though the Centers for Medicare and Medicaid services, monitor clinical labs, they do not check whether the tests conducted in the labs are clinically meaningful.
Healthcare companies like 23andMe, conducts this genetic screening and have run into issues with the FDA in the past. They were ordered to stop issuing health guidance to customers in 2013 but received clearance to offer more limited genetic screenings in 2014.
Last year, 23andMe collaborated with Celmatix to share its genetic data for a study on fertility. Celmatic was created by Beim in 2009 with a mission to better understand women’s fertility.
Celmatix’s predictive analytics software Polaris is already used by fertility clinics to gather insights about a woman’s health and suggest fertility treatments. Fertilome is not covered by insurance and costs $1,900.
Women can request the test through their doctor who will take their blood sample and send it to a Celmatix lab that uses an FDA-approved gene sequencing device and can process tests for people in all 50 states.
It will not take more than two weeks for women to get the results, Beim said. She hopes the cost of the test will eventually reduce, especially as it becomes more affordable to sequence genes.
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