Episona, which launched its epigenetic test in fertility clinics last October, is bringing it to the masses. Customers may now order the Seed test—which analyzes epigenetic marks on DNA to predict male factor infertility and poor embryo development—online for use at home.
Pasadena, California-based Episona initially rolled the test out as a physician-ordered kit that can be used at home or in the clinic. Semen samples are analyzed at a CLIA-certified lab, and two weeks later, the physician receives a report that can help guide treatment.
The test is currently offered at more than 40 fertility clinics throughout the U.S. and Canada, said Episona CEO Alan Horsager, Ph.D. But in the year since Seed’s launch, the company has received inquiries from people who wanted to get the test independently of a clinic, he said.
"Men contribute to about half the cases of infertility, but they rarely go in for doctor's appointments. We listened to the feedback from our patients, and it is now possible to order Seed online and take the test at home, all before you set foot in a doctor's office,” Horsager said in a statement.
Patients who order Seed online will receive the kit in three to five business days, after an independent physician has reviewed their case. Within three weeks, the customer and the ordering physician receive an interactive online report that can help patients make decisions about seeking fertility treatment, according to the statement.
The Seed test screens for changes in epigenetic marks in the DNA that differentiate fertile sperm from infertile sperm. Epigenetic marks are methyl groups that bind on top of DNA and regulate which genes are active or inactive. These can be thrown off-kilter by aging or environmental factors.
"As the only epigenetic test on the market for male factor infertility, Seed goes far beyond the traditional semen analysis to offer a depth of next-gen information about male fertility and embryo quality that to date has been unavailable,” said Paul Turek, M.D., medical director of The Turek Clinics and a scientific adviser to Episona, in the statement.
If epigenetic abnormalities are found in a patient’s test, Episona provides genetic counseling through a partnership with Gene Matters.